Abstract
Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing. The objectives of this research were to assess the impact of an exercise intervention in addition to routine evidence‐based care on the healing rates, functional ability and health‐related quality of life for adults with venous leg ulcers (VLUs). This study included 63 patients with VLUs. Patients were randomised to receive either a 12‐week exercise intervention with a telephone coaching component or usual care plus telephone calls at the same timepoints. The primary outcome evaluated the effectiveness of the intervention in relation to wound healing. The secondary outcomes evaluated physical activity, functional ability and health‐related quality of life measures between groups at the end of the 12 weeks. A per protocol analysis complemented the effectiveness (intention‐to‐treat) analysis to highlight the importance of adherence to an exercise intervention. Intention‐to‐treat analyses for the primary outcome showed 77% of those in the intervention group healed by 12 weeks compared to 53% of those in the usual care group. Although this difference was not statistically significant due to a smaller than expected sample size, a 24% difference in healing rates could be considered clinically significant. The per protocol analysis for wound healing, however, showed that those in the intervention group who adhered to the exercise protocol 75% or more of the time were significantly more likely to heal and showed higher rates for wound healing than the control group (P = 0·01), that is, 95% of those who adhered in the intervention group healed in 12 weeks. The secondary outcomes of physical activity, functional ability and health‐related quality of life were not significantly altered by the intervention. Among the secondary outcomes (physical activity, functional ability and health‐related quality of life), intention‐to‐treat analyses did not support the effectiveness of the intervention. However, per protocol analyses revealed encouraging results with those participants who adhered more than 75% of the time (n = 19) showing significantly improved Range of Ankle Motion from the self‐management exercise programme (P = 0·045). This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to standard care are more likely to heal and have better functional outcomes than those who do not adhere to the exercises in conjunction with usual care.
Keywords: Exercise, Healing rates, Range of Ankle Motion, Self‐management, Venous leg ulcers
Introduction
Venous leg ulcers (VLUs) account for approximately 70% of all chronic leg ulcers 1 and are the result of chronic venous insufficiency (CVI) or venous disease in the lower leg. CVI is a dysfunction of the venous system that occurs as a result of an impairment of the calf muscle pump 2. Calf muscle pump dysfunction is associated with reduced ankle range of motion, which is a risk factor for delayed healing of VLUs. Exercise that targets ankle joint mobility may lead to improvement in calf muscle pump function and subsequent healing 3, 4, 5, 6. However, little is known regarding the effect of exercise on healing, functional ability and health‐related quality of life 7, 8.
Adults with VLUs appear to have an increased risk of disease‐related comorbidities 9 such as cardiac disease and diabetes 10 for which exercise is beneficial. However, patients with VLUs have been reported as being less physically active than age‐matched controls 11, which is a concern. Although patients' problems such as sleep disturbances, impaired mobility and decreased vitality 9, 12 appear to be lifestyle related, adequate advice to improve physical activity levels is not part of common wound management practice 13.
Current treatment of VLUs includes compression therapy, local wound management and more sophisticated treatments such as bioengineered cellular technologies and negative pressure therapy. However, up to 15–30% of chronic VLUs do not respond to compression treatment 14 and remain unhealed even after a year of treatment 15, suggesting that alternative adjunct treatments are necessary.
Exercise has the potential to be both a preventative measure and a treatment. There is also evidence that lack of physical activity can impair healing 16. Despite evidence to suggest that exercise improves calf muscle function in this patient population 6, 13, 17, 18, 19, to date, few studies 13, 17, 20, 21, 22 have investigated the effect of improving calf muscle pump function on healing rates. A self‐managed exercise programme may be an important strategy in the management of VLUs as cost‐effective delivery systems are now demanded in the health care system.
The primary aim of this study was to apply a theory‐based intervention and establish whether a home‐based exercise programme facilitated by a telephone management component was effective in promoting the healing rates of VLUs. The secondary aims of this study were to determine whether a home‐based exercise programme facilitated by a telephone management component improved physical activity levels, functional ability and health‐related quality of life for adults experiencing venous leg ulceration.
Methods
Study design
A randomised controlled trial (RCT) was undertaken to determine the effectiveness of a home‐based progressive resistance exercise programme in comparison with usual care on the effects on healing rates, functional ability and health‐related quality of life for VLU patients. The study was an open‐label RCT (ACTRN12612000475842).
Patients were randomised after signed informed consent was obtained, according to a predetermined computer generated randomisation scheme, into one of two groups: a control (usual care) or intervention (exercise) group.
A team of wound care nurses at the respective clinics were trained in the protocol compression techniques for consistency. The ulcers were cleansed and dressed with routine evidence‐based care 23.
All the participating patients gave their written informed consent. The protocol was approved by the human research ethics committee at each participating centre and complied with the Helsinki Declaration ethical rules for human experimentation. Patients' freedom to withdraw consent at any time was offered.
Participants
Patients were recruited from two outpatient wound services in Queensland and a community nursing service in Victoria, Australia. All patients at the clinics were screened for inclusion in the study. The case definition for venous ulceration was any break in the skin on the lower leg, no other causative aetiology being present, appearing clinically venous and having an ankle brachial pressure index (ABPI) ≥ 0·8 ≤ 1·2. Patients were included if they were aged 18 years or older, were able to give informed consent and met the case definition. Patients were excluded if there was cognitive impairment (clinician determined), ulcers of non‐venous aetiology and/or inability to understand English.
Sample size calculations prior to commencement of the study found a sample of 110 participants would be required. Power analyses were based on the following parameters: 80% power; 95% significance level 24. Significant clinical differences between groups were based on results from previous work in this area (e.g., a 0·2 difference in proportions of patients healed) and allowing for a 20% early drop‐out rate. Detailed information on the intervention protocol has been published 25.
Intervention
Patients in the intervention group participated in a home‐based progressive resistance exercise programme for 12 weeks. These exercises could be reproduced in the patients' own homes without the use of any additional equipment and had previously been demonstrated as feasible 20. For patients randomised to the exercise programme, the research nurse demonstrated the exercise protocol and provided feedback to the patient regarding their technique. All patients in the intervention group received an author‐developed exercise booklet (available upon request), a pedometer (used as a motivational tool to improve daily step count), ‘Keep it up’ worksheets to diarise their sets and repetitions of the exercises recommended and to record their daily steps and a ‘Taking care of your legs’ information sheet. The exercise protocol (Table 1) was designed with the intention that all patients started at the same level and only graduated to the next level upon successful completion of the current level for at least 3 days or until recommended by the first author. All patients received telephone calls at regular time points (weeks 1, 2, 4, 6, 8 and 12) throughout the 12 weeks. The purpose of the calls to the intervention group participants was to record current exercise level and set goals for the next phase. Stretching was recommended prior to and following each exercise session. These stretches targeted the calf and hamstring musculature and were performed in both of the lower limbs. Patients were instructed to perform each stretch to the point that elicited comfortable tension but no pain. At the point of tension, each stretch was held for 20 seconds. Detailed information on the intervention protocol has been previously published 25.
Table 1.
Exercise protocol
| Stage 1. Seated heel‐rises (both legs) |
| 10 × 3 sets three times per day everyday |
| 15 × 3 sets three times per day everyday |
| 20 × 3 sets three times per day everyday |
| 25 × 3 sets three times per day everyday |
| Stage 2. Standing heel‐rises (both legs) |
| 10 × 3 sets three times per day everyday |
| 15 × 3 sets three times per day everyday |
| 20 × 3 sets three times per day everyday |
| 25 × 3 sets three times per day everyday |
| Stage 3. One‐legged heel‐rises |
| 10 × 3 sets three times per day everyday |
| 15 × 3 sets three times per day everyday |
| 20 × 3 sets three times per day everyday |
| 25 × 3 sets three times per day everyday |
Usual care group
The patients assigned to the usual care group were required to complete the questionnaires at baseline and the activity diary throughout the study. In order to minimise attrition over the 3‐month study duration, patients in the usual care group received a bag with a generic information brochure ‘Taking care of your legs’, a pedometer (used as a motivational tool to improve daily step count) and ‘Keep it up’ worksheets to diarise their step count. The usual care group received phone calls at the same time points as the intervention group; however, they were not provided with any exercise‐related goal setting strategies or advice from the principal author. If at any point a participant in the usual care group asked for exercise advice, they were referred to the wound care nurses in the clinic to discuss standard advice.
Outcome measures
Data on demographics, health, medical history and ulcer characteristics were collected from medical records and patient questionnaires at baseline. Information on variables known to influence ulcer healing, that is, ulcer size, duration and age 10, were collected to include in the final analysis. Data on progress in healing and treatments were collected fortnightly or monthly for 12 weeks from baseline. The primary outcome was ulcer healed (yes/no). Progress in wound healing was measured with the following methods: the ulcer area was calculated from wound tracings and a portable digital planimetry device, Visitrak Digital (Smith & Nephew Medical Limited, Hull, England), was used to determine ulcer areas. The Pressure Ulcer Healing Score (PUSH) tool for ulcer healing 26 was used to provide a broader measure of healing than examining the area alone, covering area, exudate and the type of wound bed tissue, and clinical data related to healing progress such as presence of oedema, eczema, inflammation and signs of infection were also collected.
Secondary outcome measures included self‐reported physical activity from the Yale Physical Activity Survey (YPAS) 27. Functional ability measures included the Tinetti Gait and Balance measure 28 and Range of Ankle Motion (ROAM), which was measured in degrees by goniometry [baseline plastic 360° ISOM (STFR), New York] with the participant sitting with their knee at a 45° angle; this was validated by Back et al. (1995) 29. The health‐related quality of life measure was the Medical Outcomes Survey Short Form‐8 questionnaire (SF‐8) 30.
Exercise adherence data were obtained from the data sheets recorded on paper during phone calls. Adherence to leg exercises was defined as undertaking the recommended exercise intervention for ≥75% of the time in order to comply with protocol. All patients received phone calls to measure self‐reported exercise at weeks 2, 4, 6, 8 and 12. A Likert scale that asked the participants how often they were performing leg exercises and/or walking was used; response categories were 0 = not at all, 1 = some or a little of the time and 2 = most or all of the time. The same scale was used for both the leg exercises and walking measure. Therefore, the maximum score a participant could record across the 5 data collection points was 10.
Statistical analysis
Data analysis was conducted using the software package SPSS for Windows Release 21.0 (SPSS Inc., Chicago, IL). Baseline demographic, health and ulcer characteristics were analysed to check for comparability of the two groups. Descriptive analyses were undertaken for all variables. A χ 2 test for independence was used to identify if there was a significant difference between the numbers in each group healed by week 12. To test for the effect of the intervention over time, a two‐way analysis of variance (ANOVA) was conducted on the remaining outcome variables. Group (intervention versus usual care) was the between‐subject factor, and time (baseline and week 12) was the within‐subject or repeated measures factor. Because of the small sample size, further tests were conducted to check the assumptions of the statistical tests to be used. The results showed that using Mauchly's Test, the sphericity assumptions of repeated measures for ANOVA were met. Furthermore, tests of homogeneity of variance of assumptions also confirmed that this assumption was met.
Results
Between July 2012 and April 2014, 340 patients were screened, 63 of whom underwent randomisation (Figure 1). Reasons for exclusion were (i) not meeting the inclusion criteria, (ii) not wishing to participate and (iii) unable to be followed up.
Figure 1.
Flow of participants through study.
Sixty‐two patients with venous leg ulceration, 32 males (51·6%) and 30 females (48·4%) aged between 31 and 97 years (mean 71·5 ± 14·6 years), met all the inclusion criteria and were randomised per protocol to an intervention or usual care group for the duration of the study. The mean age of the intervention group was 71·3 years (SD ± 15·8) and usual care group was 71·7 years (SD ± 13·4) which were comparable, t (−0·007) = 479·5, P = 0·99. Baseline ulcer characteristics are detailed in Table 2, and Table 3 provides comparison between groups for the physical, functional and health‐related quality of life outcomes. Baseline characteristics (ulcer area and ulcer duration) of the randomised patients were homogenous in the two compared groups.
Table 2.
Baseline ulcer characteristics for the entire cohort and groups
| Test | |||||
|---|---|---|---|---|---|
| Mann–Whitney U | |||||
| Ulcer characteristics | Total | Usual care Median (range) | Intervention | t‐test | P |
| Ulcer duration (weeks) | 16 (2–416) | 14 (3–234) | 16 (2–416) | 462·5 | 0·85 |
| Mean (SD) | |||||
|---|---|---|---|---|---|
| Ulcer area (cm2) | 7·5 (±11) | 6·0 (±8·3) | 8·8 (±1·4) | −0·9 | 0·34 |
| PUSH score* | 9·2 (±3·5) | 9·7 (±3·3) | 9·2 (±3·5) | 0·58 | 0·49 |
| Total, n (%) | Usual care, n (%) | Intervention, n (%) | x 2 | ||
|---|---|---|---|---|---|
| Compression (>30 mmHg) | 33 (53%) | 16 (53%) | 17 (53%) | 0·00 | 0·99 |
Pressure Ulcer Healing Score (PUSH) (0–17).
Table 3.
Baseline and week 12 characteristics for the physical, functional and health‐related quality of life measures
| Baseline | Week 12 | |||||
|---|---|---|---|---|---|---|
| Usual care | Intervention | Test | P | Usual care | Intervention | |
| t‐test | ||||||
| PCS* | 42 (±8·8) | 45 (±8·3) | −1·42 | 0·14 | 43 (±8·9) | 46 (±10·2) |
| Mann–Whitney U | ||||||
| ROAM† | 23 (9–50) | 29 (8–55) | 311 | 0·18 | 24 (9–50) | 32 (12–55) |
|
YPAS‡ Total activity index§ |
21 (8–89) | 30 (11–79) | 578 | 0·06 | 21 (8–86) | 37 (12–93) |
| Tinetti Gait and Balance¶ | 20 (7–28) | 25 (6–28) | 531 | 0·21 | 16 (7–28) | 23 (10–28) |
| MCS** | 50 (26–65) | 53 (16–63) | 427·5 | 0·91 | 51 (32–66) | 51 (16–65) |
Physical Component Summary Scale of the SF‐8 survey, a health‐related quality of life measure. The scale is designed to have a mean of 50 where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Range of ankle motion – range 0–60°, where higher scores indicate greater ankle range of motion.
Yale Physical Activity Survey.
Total activity index = frequency × duration × weighting factor for activities (possible range 0–137).
Tinetti gait and balance score ‐ range 0–28, where higher scores indicate greater balance and gait ability
Mental Component Summary Scale of the SF‐8. The scale is designed to have a mean of 50 where 0 indicates the lowest level of health and 100 indicates the highest level of health.
Effectiveness
Of the sample, 63% had healed within 12 weeks, while 37% had not. Intention‐to‐treat analysis showed that 77% of those in the intervention group had healed compared to 53% of those in usual care. A χ 2 test for independence indicated no significant difference in the proportion of those who healed in the intervention group compared with those in the usual care group, X 2 (1, n = 59) = 2·75, P = 0·09.
Among secondary outcomes, the YPAS analysis revealed no interaction effect between group and time or the main effect for comparing usual care to intervention. However, there was a significant improvement over time, Wilks λ = 0·88 (F1, 56 = 7·41, P = 0·01).
The Tinetti Gait and Balance analysis revealed no interaction effect between group and time, and the main effects for comparing group and time were also not significant. ROAM analysis revealed no interaction effect between group and time or the main effect for comparing usual care to intervention. However, there was a significant improvement over time, Wilks λ = 0·92 (F1, 47 = 4·04, P = 0·05).
Physical and mental health‐related quality of life [Physical Component Score (PCS) and Mental Component Score (MCS)] analysis revealed no interaction effect between group and time, and the main effects for comparing group or time were also not significant. The overall results for the effectiveness analyses are presented in Table 4.
Table 4.
Summary of the effectiveness and efficacy of the secondary outcomes
| Effectiveness | Efficacy | |||||
|---|---|---|---|---|---|---|
| Outcome | Group × time | Time | Group | Group × time | Time | Group |
| Yale Physical Activity Survey | 0·44 | 0·01* | 0·09 | 0·20 | 0·01* | 0·04† |
| Tinetti Gait and Balance score | 0·45 | 0·17 | 0·15 | 0·75 | 0·33 | 0·04† |
| Balance | 0·57 | 0·17 | 0·34 | 0·81 | 0·31 | 0·17 |
| Gait | 0·69 | 0·43 | 0·68 | 0·13 | 0·96 | 0·20 |
| Range of ankle motion | 0·07 | 0·05† | 0·06 | 0·07 | 0·06 | 0·05† |
| Physical component summary | 0·71 | 0·39 | 0·13 | 0·32 | 0·16 | 0·03† |
| Mental Component summary | 0·81 | 0·74 | 0·93 | 0·71 | 0·94 | 0·93 |
Significant P ≤ 0·01.
Significant P ≤ 0·05.
Per protocol analysis
Adherence in this study was defined as completing either the leg and/or walking exercises 75% of the time, determined as any score ≥7·5 out of 10. A χ 2 test for independence indicated a significant difference in the proportion of those who healed between those who were adherent in the intervention group (n = 19) compared with those in the usual care group, x 2 (1, n = 47) = 7·31, P = 0·001.
Among the secondary outcomes in the per protocol analysis, the YPAS revealed no interaction effect between group and time. The main effect for comparing the usual care group to ‘adherers’ of the intervention was significant (F1, 45 = 4·26, P = 0·04), and there was also a main effect for time, Wilks λ = 0·84 (F1, 45 = 8·31, P = 0·01).
The Tinetti Gait and Balance combined score revealed no interaction effect between group and time. The main effect for group was significant, Wilks λ = 0·91 (F1, 43 = 4·5, P = 0·04). However, there was no main effect for time. The ROAM score revealed no interaction effect between group and time. The main effect for comparing group was significant, Wilks λ = 0·89 (F1, 40 = 3·9, P = 0·05). There was no main effect for time.
The PCS score revealed no interaction effect between group and time. The main effect for comparing usual care to intervention was significant, Wilks λ = 0·86 (F1, 42 = 5·07, P = 0·03).There was no main effect for time. The MCS score revealed no interaction effect between group and time. The main effects for group and time were also not significant.
Discussion
Patients who received a home‐based exercise self‐management programme in addition to usual care (evidence‐based compression therapy plus wound care) as an intervention demonstrated a trend toward healing at a faster rate compared to participants in the usual care group. The study, as originally designed, required a sample size of 55 per group for 80% power and α 0·05; however, as only 63 participants were enrolled, the study was underpowered to detect an effect. It is noteworthy that to date, this is the largest RCT to assess the effectiveness of an exercise programme on the healing rates of open VLUs; other studies have had samples ranging between 12 and 40 patients 17, 20, 21.
In the present study, the overall healing rate following 12 weeks of compression therapy was 63%. Seventy‐seven percent of those in the intervention group healed by 12 weeks compared to 54% who healed in the usual care group. These overall healing rates were similar to those in previous studies. An experimental study of prescribed walking and multilayer compression bandaging 21 reported between 76% and 83% of ulcers healed at 12 weeks. Another RCT 31 found that at 16 weeks, 62% of venous ulcers healed with four‐layer bandaging and 73% with short‐stretch bandaging.
The only other studies to measure healing as an outcome in an exercise study have reported mixed outcomes with varying endpoints, making direct comparison difficult. Heinen et al. 13 reported that their intervention group had less wound days (P < 0·01), and Meagher et al. 21 observed that participants who took more steps at both the baseline and 4‐week assessment healed more quickly than those who took fewer steps (P = 0·052 and P = 0·008 for baseline and week 4, respectively). In contrast, Jull et al. 17 reported no significant differences in ulcer healing parameters (change in area, percentage change in area, number healed at 12 weeks, time to healing).
Adherence is often poorly defined in exercise studies; however, it is an important factor contributing to the effectiveness of exercise‐based programmes 32. Of the 32 participants randomised to the intervention group, only 59% (n = 19) adhered to the prescribed leg exercises ≥ 75% of the time as per self‐reported data. However, it is of statistical and clinical significance to note that of those 19 who adhered, 18 healed during the 12‐week intervention. Self‐management is often difficult to achieve as indicated by poor rates of adherence to treatment guidelines 33. The poor adherence rates observed in this current study are in direct contrast to the same protocol applied in a face‐to‐face clinic setting 20. Jull et al. 17 also reported high adherence rates with nurses recommending exercises, suggesting the importance of face‐to‐face exercise advice for this patient population.
Interestingly, all patients improved their general physical activity levels over time. It is worthwhile to note that this is a similar finding to Heinen et al. 13 where it was also observed that walking behaviour was enhanced in both the intervention and usual care groups as part of being involved in an exercise study; however, the general improvement in physical activity does not seem to translate to improved healing outcomes.
The exercise protocol was designed to activate the calf muscle pump to promote venous return; however, our qualitative study has previously highlighted the need to address balance and gait in this population 34. A significant difference in pre–post testing for the Tinetti Gait and Balance measure was noted between groups for those who adhered to the intervention compared to usual care. This is clinically significant, and further research is warranted to include specific gait training to determine if this translates to improve healing and functional outcomes for adults with VLUs.
Similar to the time effect noted for improvement in physical activity levels, participants were also shown the type of ankle exercises at baseline prior to randomisation. Therefore, the demonstration may also have led to those in the usual care implementing their own ankle exercise routine. However, a group effect was noted for those who adhered to the exercise protocol, highlighting an important finding that the intervention is effective is improving ROAM as a self‐management program. However, a recent study has suggested that ankle range of motion is not important in VLU healing or, more likely, is overcome by compression 35. Further research is warranted.
The overall findings regarding functional ability in the current study support those found by other recent research 13 in the ‘lively legs programme,’ where the authors concluded that the non‐significant effects regarding physical outcomes may relate to the frailty of the sample. While this may also apply to the current sample, it is also likely that non‐adherence to a self‐management programme may also be a reason for the non‐significant results. This may also be one reason why unsupervised home‐based exercise programmes are deemed ineffective when in reality, ‘an inefficient regimen effect’ has occurred 36.
Numerous studies have found diminished quality of life scores for patients with VLUs compared with the general population or patients with milder CVI 37, 38. However, studies investigating the effect of exercise intervention on quality of life with this population have been scarce 19, 39. The intention‐to‐treat analysis revealed no interaction effect between group and time or between groups or time overall for PCS or MCS. However, PCS between groups was significant for the per protocol analysis. It is postulated that 12 weeks is not a very long period of time to significantly affect health‐related quality of life, or the measure of health‐related quality of life needs to be disease‐specific instead of being general as in the SF‐8.
Limitations
There are several limitations to this study. First, the sample size calculation was not stratified based on factors such as ulcer duration or size, recruitment site or physical activity levels because of the additional number in sample size that would have been required. In addition, the smaller‐than‐anticipated sample hindered the effort to detect significant change. The study was stopped prior to the desired sample size being reached because of the constraints within a PhD timeline. Although statistical significance was not reached in relation to the wound‐healing primary outcome, it could be argued with a larger sample size, it would be likely to be significant. An interaction effect was not observed for the effectiveness analyses for the primary and secondary outcomes. Interestingly though, it was noted that a time effect was observed. This is possibly because of an attention effect, suggesting that perhaps less information and demonstration given at recruitment prior to randomisation may be needed to see a true effect between groups. Second, outcome assessment was unblinded as was treatment allocation. Participants could not be blinded to treatment assignment. Because virtually all measures of daily functioning and Health related quality of life (HRQoL) are based on self‐report, knowledge of treatment could bias findings. Investigator bias is possible as the analysis was primarily conducted by the first author who provided the home‐based exercise programme. However, this was limited by following a strict protocol and predetermined sheet for collecting data and providing support during the telephone follow‐up. Third, this study was only for a 12‐week period. The self‐management programme consisted of self‐management activities that were expected to be self‐sustainable and could have been followed‐up long term. Therefore, assessment of outcome variables was only carried out during this period. The study was conducted over a limited amount of time compared to the duration of chronic venous leg ulceration. Improvement of some of the outcome variables, such as quality of life, may need a longer duration to appear. A longer observation period is suggested for future studies. Finally, the ethnic make‐up of this sample limits generalisability, with the majority of participants being Caucasian.
Conclusion
Studies have shown that calf muscle exercises are effective in improving the haemodynamics of the venous system. This study has shown that those participants who adhere to the exercise programme as an adjunctive treatment to usual care are significantly more likely to heal than those who do not adhere to the exercises and standard care. Future studies should focus on ways to improve adherence with this patient population.
Authors' contributions
JOB conceived the study and was involved with the design, recruitment, data collection, analysis and draft of the manuscript. HE, KF and GK participated in the design of the study and statistical analysis. All authors read and approved the final manuscript.
Acknowledgements
No competing interests to be declared.
References
- 1. Abbade LPF, Lastoria S. Venous ulcer: epidemiology, physiopathology, diagnosis and treatment. Int J Dermatol 2005;44:449–56. [DOI] [PubMed] [Google Scholar]
- 2. Yim E, Kirsner RS, Gailey RS, Mandel DW, Chen SC, Tomic‐Canic M. Effect of physical therapy on wound healing and quality of life in patients with venous leg ulcers: a systematic review. JAMA Dermatol 2014;151:320–27. [DOI] [PubMed] [Google Scholar]
- 3. Qiao T, Liu C, Ran F. The impact of gastrocnemius muscle cell changes in chronic venous insufficiency. Eur J Vasc Endovasc Surg 2005;30:430–6. [DOI] [PubMed] [Google Scholar]
- 4. Van Uden CJT, Van der Vleuten CJM, Kooloos JGM, Haenen JH, Wollersheim H. Gait and calf muscle endurance in patients with chronic venous insufficiency. Clin Rehabil 2005;19:339–44. [DOI] [PubMed] [Google Scholar]
- 5. Orsted HL, Radke L, Gorst R. The impact of musculoskeletal changes on the dynamics of the calf muscle pump. Ostomy Wound Manage 2001;47:18. [PubMed] [Google Scholar]
- 6. Yang V, Stacey S. Effect of exercise on calf muscle pump function in patients with chronic venous disease. Br J Surg 1999;86:338–41. [DOI] [PubMed] [Google Scholar]
- 7. Simka M. Calf muscle pump impairment and delayed healing of venous leg ulcers: air plethysmographic findings. J Dermato 2007;34:537–44. [DOI] [PubMed] [Google Scholar]
- 8. Barwell JR, Taylor M, Deacon J, Davies C, Whyman MR, Poskitt KR. Ankle motility is a risk factor for healing of chronic venous leg ulcers. Phlebology 2001;16:38–40. [Google Scholar]
- 9. Persoon A, Heinen MM, van der Vleuten CJ, de Rooij MJ, van de Kerkhof PC, van Achterberg T. Leg ulcers: a review of their impact on daily life. J Clin Nurs 2004;13:341–54. [DOI] [PubMed] [Google Scholar]
- 10. Margolis DJ, Knauss J, Bilker W. Epidemiology and health services research medical conditions associated with venous leg ulcers. Br J Dermatol 2004;150:267–73. [DOI] [PubMed] [Google Scholar]
- 11. Heinen M, Van Der Vleuten C, De Rooij M, Uden C, Evers A, Van Achterberg T. Physical activity and adherence to compression therapy in patients with venous leg ulcers. Arch Dermatol 2007;143:1283–8. [DOI] [PubMed] [Google Scholar]
- 12. Heinen M, Persoon A, Otero M, Van Achterberg T. Ulcer‐related problems and health care needs in patients with venous leg ulceration: a descriptive, cross‐sectional study. Int J Nurs Stud 2007;44:1296–303. [DOI] [PubMed] [Google Scholar]
- 13. Heinen M, Borm G, van der Vleuten C, Evers A, Oostendorp R, van Achterberg T. The lively legs self‐management programme increased physical activity and reduced wound days in leg ulcer patients: results from a randomized controlled trial. Int J Nurs Stud 2012;49:151–61. [DOI] [PubMed] [Google Scholar]
- 14. O'Meara S, Cullum N, Nelson E. Compression for venous leg ulcers. Cochrane Database Syst Rev 2009;1:CD000265. [DOI] [PubMed] [Google Scholar]
- 15. Kurd SK, Hoffstad OJ, Bilker WB, Margolis DJ. Evaluation of the use of prognostic information for the care of individuals with venous leg ulcers or diabetic neuropathic foot ulcers. Wound Repair Regen 2009;17:318–25. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 16. Radek KA, Baer LA, Eckhardt J, DiPietro LA, Wade CE. Mechanical unloading impairs keratinocyte migration and angiogenesis during cutaneous wound healing. J Appl Physiol 2008;104:1295–303. [DOI] [PubMed] [Google Scholar]
- 17. Jull A, Parag V, Walker N, Maddison R, Kerse N, Johns T. The PREPARE pilot RCT of home‐based progressive resistance exercises for venous leg ulcers. J Wound Care 2009;18:497–503. [DOI] [PubMed] [Google Scholar]
- 18. Kan M, Delis K. Hemodynnamic effects of supervised calf muscle exercise in patients with venous leg ulceration: a prospective controlled study. Arch Surg 2001;136:1364–9. [DOI] [PubMed] [Google Scholar]
- 19. Padberg FT Jr, Johnston MV, Sisto SA. Structured exercise improves calf muscle pump function in chronic venous insufficiency: a randomized trial. J Vasc Surg 2004;39:79–87. [DOI] [PubMed] [Google Scholar]
- 20. O'Brien J, Edwards H, Stewart I, Gibbs H. A home‐based progressive resistance exercise programme for patients with venous leg ulcers: a feasibility study. Int Wound J 2013;10:389–96. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 21. Meagher H, Ryan D, Clarke‐Moloney M, O'Laighin G, Grace PA. An experimental study of prescribed walking in the management of venous leg ulcers. J Wound Care 2012;21:421–30. [DOI] [PubMed] [Google Scholar]
- 22. Kelechi TJ, Mueller M, Spencer C, Rinard B, Loftis G. The effect of a nurse‐directed intervention to reduce pain and improve behavioral and physical outcomes in patients with critically colonized/infected chronic leg ulcers. J Wound Ostomy Continence Nurs 2014;41:111–21. [DOI] [PubMed] [Google Scholar]
- 23. Australian Wound Management Association (AWMA) . Austalian and New Zealand clinical practice guidelines for prevention and management of venous leg ulcers. Barton: ACT, 2011. [Google Scholar]
- 24. Collett D. Modelling Survival Data in Medical Research, 2nd edn. Boca Raton: Chapman & Hall/CRC, 2003. [Google Scholar]
- 25. O'Brien JA, Finlayson KJ, Kerr G, Edwards HE. Testing the effectiveness of a self‐efficacy based exercise intervention for adults with venous leg ulcers: protocol of a randomised controlled trial. BMC Dermatol 2014;14:16. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 26. Stotts NA, Rodeheaver GT, Thomas DR, Frantz RA, Bartolucci AA, Sussman C, Ferrell BA, Cuddigan J, Maklebust J. An instrument to measure healing in pressure ulcers: development and validation of the pressure ulcer scale for healing (PUSH). J Gerontol A Biol Sci Med Sci 2001;56:M795–9. [DOI] [PubMed] [Google Scholar]
- 27. Dipietro L, Caspersen CJ, Ostfeld AM, Nadel ER. A survey for assessing physical activity among older adults. Med Sci Sports Exerc 1993;25:628–42. [PubMed] [Google Scholar]
- 28. Kegelmeyer DA, Kloos AD, Thomas KM, Kostyk SK. Reliability and validity of the tinetti mobility test for individuals with parkinson disease. Phys Ther 2007;87:1369–78. [DOI] [PubMed] [Google Scholar]
- 29. Back TL, Padberg FT Jr, Araki CT, Thompson PN, Hobson RW 2nd.. Limited range of motion is a significant factor in venous ulceration. J Vasc Surg 1995;22:519–23. [DOI] [PubMed] [Google Scholar]
- 30. Ware JE, GlaxoSmithKline . How to score and interpret single‐item health status measure: a manual for users of the SF‐8 Health Survey. Lincoln: Quality Metric Incorporated, 2001. [Google Scholar]
- 31. Partsch H, Damstra RJ, Tazelaar DJ, Schuller‐Petrovic S, Velders AJ, de Rooij MJ, Tjon Lim Sang RRM, Quinlan D. Multicentre, randomised controlled trial of four‐layer bandaging versus short‐stretch bandaging in the treatment of venous leg ulcers. J Vascul Dis 2001;30:108–13. [DOI] [PubMed] [Google Scholar]
- 32. Bollen JC, Dean SG, Siegert RJ, Howe TE, Goodwin VA. A systematic review of measures of self‐reported adherence to unsupervised home‐based rehabilitation exercise programmes, and their psychometric properties. BMJ Open 2014;4:e005044. [DOI] [PMC free article] [PubMed] [Google Scholar]
- 33. Newman S, Steed L, Mulligan K. Self‐management interventions for chronic illness. Lancet 2004;364:1523–37. [DOI] [PubMed] [Google Scholar]
- 34. O'Brien J, Finlayson K, Kerr G, Edwards H. Perspectives about exercise from adults with venous leg ulcers: an exploratory study. J Wound Care 2014;23:496–509. [DOI] [PubMed] [Google Scholar]
- 35. Yim E, Richmond NA, Baquerizo K, Van Driessche F, Slade HB, Pieper B, Kirsner RS. The effect of ankle range of motion on venous ulcer healing rates. Wound Repair Regen 2014;22:492–6. [DOI] [PubMed] [Google Scholar]
- 36. Sackett D. A compliance practicum for the busy practitioner. Baltimore: Johns Hopkins University Press, 1979:286–94. [Google Scholar]
- 37. Kahn SR, M'lan CE, Lamping DL, Kurz X, Bérard A, Abenhaim LA. Relationship between clinical classification of chronic venous disease and patient‐reported quality of life: results from an international cohort study. J Vasc Surg 2004;39:823–8. [DOI] [PubMed] [Google Scholar]
- 38. Moura RM, Gonçalves GS, Navarro TP, Britto RR, Dias RC. Relationship between quality of life and the CEAP clinical classification in chronic venous disease. Braz J Phys Ther 2010;14:99–105. [PubMed] [Google Scholar]
- 39. Zajkowski PJ, Draper T, Bloom J, Henke PK, Wakefield TW. Exercise with compression stockings improves reflux in patients with mild chronic venous insufficiency. Phlebology 2006;21:100–4. [Google Scholar]