Abstract
Aims
To clarify the long-term effects of short-term exercise instructions by physical therapists in Japanese people with type 2 diabetes (T2D).
Methods
This was a follow-up study of 2 years after randomized controlled study of short-term exercise instructions included 18 patients (5 in the non-intervention and 13 in the intervention groups). Motor skills, including 6 min walk test scores, and transtheoretical model was evaluated at baseline (week 0), the end of the study of the previous study (week 8), and 2 years after (2 years).
Results
In the intervention group, changes in 6 min walk distance, which was significant at 8 weeks (from 445 (420–480) m to 490 (450–520) m, p = 0.01)), were maintained at 2 years (496 (420–540) m, p = 0.05), whereas in the non-intervention group, there were no changes in 6 min walk distance at 8 weeks (from 460 (458–493) m to 464 (460–485) m, p = 0.86) and 2 years (490 (480–506) m, p = 0.63). Furthermore, the changes in transtheoretical model, which was significant at 8 weeks (p = 0.008), were maintained at 2 years (p = 0.02), whereas in the non-intervention group, there were no changes in 6 min walk distance at 8 weeks and 2 years. On the other hand, the other markers were not significantly different between week 8 and 2 years compared to baseline in both groups.
Conclusions
Short-term outpatient exercise instruction by physical therapists may lead to long-term improvement effect on walking ability in people with T2D.
Keywords: Diabetes mellitus, Exercise, Physical therapist, 6 min walking test, Transtheoretical model
Introduction
The number of people with diabetes are increasing and reaching 537 million in 2021 [1]. To prevent the onset and progression of diabetic complications is a major global challenge from the perspective of extending healthy life expectancy and reducing healthcare costs [2]. It is well known that exercise therapy is one of an important part of the treatment of diabetes [3, 4]. However, about 30% of people with diabetes did not receive exercise guidance; furthermore, there was little instruction provided by physical therapists in Japan [5].
Previous studies have shown the effectiveness of instruction of aerobic exercise for people with type 2 diabetes (T2D) in western countries [6]. On the other hand, few studies have investigated the effectiveness of instruction of exercise in Japanese people with T2D. We have shown the effectiveness of instruction of aerobic exercise by physical therapists for people with T2D, which indicated that intervention by physical therapists at 0 and 4 weeks was effective for glycemic control, number of steps per day, lower extremity muscle strength, and 6 min walk test after 8 weeks [7].
Few studies have examined the long-term effects of exercise training intervention in people with diabetes [8, 9]. In this follow-up study 2 years after the study, we investigated the long-term effects of short-term exercise instructions by physical therapists in Japanese people with T2D.
Patients and methods
Ethics
The study was approved by the local ethics committee of Matsushita Memorial Hospital (approval number: 22017) and conducted according to the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants.
Inclusion and exclusion criteria
In this study, we included the people who participated the study conducted previously [7]. Briefly, people with T2D, without pregnant or breastfeeding, HbA1c ≥ 10%, receiving insulin therapy or contraindications to exercise therapy were participated the previous study [7]. In this follow-up study, we excluded the people who have not attended our hospital, people who were unable to perform the assessment due to acute illness, and people who were not agree with participation to this study.
Study participants
In this study, the participants were divided into two groups, control and intervention groups, referring to the pervious study [7]. In the previous study, all participants were provided ambulatory accelerometers (Active style Pro HJA-750C) and were instructed to hold them when exercising or going out from week 4 to week 8 and medication were not changed during the study period. The participants of intervention group received exercise instructions from physical therapists for 30 min by referring to ambulatory accelerometer records at week 0 and week 4 [10]. During the two years following the end of the first study, there was no exercise instruction in either group and no intervention in the clinical settings including visiting doctor.
Data collection
Each data, including laboratory parameters, motor skills, body composition and transtheoretical model were measured at baseline (week 0) and the end of the study of the previous study (week 8), and 2 years after the previous study (2 years after). Participants were classified as past or current smokers or non-smokers. A multifrequency impedance body composition analyzer (InBodyS10, Tokyo, Japan), which has been reported to correlate well with dual-energy X-ray absorptiometry findings [11], was used to evaluate body composition. Skeletal muscle mass index (kg/m2), dividing appendicular muscle mass (kg) by height squared (m2), was calculated. Motor skills, including 6 min walk test scores, lower extremity muscle strength [12], and handgrip strength, were evaluated in the same methods as before [7]. The participants were divided into precontemplation, contemplation, preparation, action, or maintenance using the transtheoretical model, which was assessed by physical therapists at baseline (week 0) and the end of the study of the previous study (week 8), and 2 years after the previous study (2 years after) [13].
Statistical analyses
Variables are presented as absolute number or median ± interquartile range. The p-value < 0.05 was set as statistically significant. Statistical analyses were performed using the JMP software, version 13.2.1.
Participants were divided into control and intervention groups. The intervention group was the group that received physical therapist intervention in the previous study.
Wilcoxon’s rank sum test for continuous variables and Fisher’s exact test for categorical variables were performed for comparison between the groups. Wilcoxon’s signed-rank test was performed for comparison of changes within group.
Results
Study participants
Of the 29 patients with type 2 diabetes previously included in the study (13 in the non-intervention group and 16 in the intervention group), 26 patients (12 in the non-intervention group and 14 in the intervention group) who were attending our hospital were included in the study. After excluding dropouts (7 in the non-intervention group and 1 in the intervention group (refusal to participate in the study, hospitalization due to complications), 5 patients in the non-intervention group and 13 in the intervention group were included in the analysis (Fig. 1). The background of study participants at baseline (week 0) is shown in Table 1. Mean age (61 (54–65) years in the non-intervention group and 66 (55–72) years in the intervention group, p = 0.62), gender (3 male in the non-intervention group and 11 males in the intervention group, p = 0.53), and HbA1c levels (7.4 (7.4–7.5) % in the non-intervention group and 7.3 (7.2–8.0) % in the intervention group, p = 0.32) were not significantly different between the groups. Furthermore, there were no significant differences between the groups at baseline in any other factor.
Fig. 1.
Inclusion and exclusion flow
Table 1.
Characteristics at baseline
| Non-intervention group | Intervention group | P | |
|---|---|---|---|
| Age (years) | 61 (54–65) | 66 (55–72) | 0.62 |
| Sex (male/female) | 3/2 | 11/2 | 0.53 |
| Body mass index (kg/m2) | 26.0 (22.9–30.2) | 23.9 (22.9–27.8) | 0.53 |
| Skeletal muscle mass (kg) | 29.2 (25.5–32.0) | 26.5 (24.9–28.9) | 0.20 |
| Body fat mass (kg) | 21.9 (14.8–34.7) | 19.8 (18.7–26.6) | 0.91 |
| Skeletal muscle mass index (kg/m2) | 7.8 (7.1–9.0) | 7.5 (6.9–7.7) | 0.16 |
| Visceral fat area (cm2) | 94.4 (58.8–159.0) | 100.2 (84.0–140.9) | 0.82 |
| Smoking (never/past or current) | 2/3 | 7/6 | 1 |
| HbA1c (%) | 7.4 (7.4–7.5) | 7.3 (7.2–8.0) | 0.32 |
| Handgrip strength (kg) | 30.3 (23.6–35) | 31.1 (25.2–36.9) | 0.85 |
| Lower-extremity muscle strength (kg) | 32.4 (29.5–32.6) | 34.0 (25.3–37.6) | 0.92 |
| 6-min walk test (m) | 460 (458–493) | 445 (420–480) | 0.40 |
| Montreal cognitive assessment-Japanese | 27 (26–28) | 26 (24–27) | 0.66 |
| Transtheoretical model (precontemplation, contemplation, preparation, action or maintenance) (n = 12 in intervention group) | 1/1/2/1 | 6/5/1/0 | 0.09 |
All continuous variables are presented as median (interquartile range) or absolute number. Differences were considered statistically significant at P values < 0.05
Change of each parameter from baseline in each group
Table 2 shows change of parameters from baseline in each group. In the intervention group, changes in 6 min walk distance, which was significant at 8 weeks (from 445 (420–480) m to 490 (450–520) m, p = 0.01)), were maintained at 2 years (496 (420–540) m, p = 0.05), whereas in the non-intervention group, there were no changes in 6 min walk distance at 8 weeks. Furthermore, the changes in transtheoretical model, which was significant at 8 weeks (p = 0.008), were maintained at 2 years (p = 0.02), whereas in the non-intervention group, there were no changes in 6 min walk distance at 8 weeks and 2 years.
Table 2.
Change of each parameter from baseline in each group
| Non-intervention group | Intervention group | |||||
|---|---|---|---|---|---|---|
| Week 0 | Week 8 | 2 years | Week 0 | Week 8 | 2 years | |
| Body mass index (kg/m2) | 26.0 (22.9–30.2) | 26.5 (23.1–29.8) | 25.2 (22.5–28.5) | 23.9 (22.9–27.8) | 23.8 (23.3–28.4) | 23.8 (22.2–28.4) |
| HbA1c (%) | 7.4 (7.4–7.5) | 7.5 (7.4–7.8) | 7.4 (7.1–7.5) | 7.3 (7.2–8.0) | 6.9 (6.7–7.3)* | 7.0 (6.6–7.3) |
| Skeletal muscle mass (kg) | 29.2 (25.5–32.0) | 27.9 (25.5–32.5) | 26.6 (24.5–30.6) | 26.5 (24.9–28.9) | 27.0 (24.6–28.8) | 26.1 (24.7–28.5) |
| Body fat mass (kg) | 21.9 (14.8–34.7) | 22.4 (14.3–34.8) | 22.2 (14.0–32.7) | 19.8 (18.7–26.6) | 20.6 (18.0–28.2) | 19.3 (17.9–28.3) |
| Skeletal muscle mass index (kg/m2) | 7.8 (7.1–9.0) | 7.8 (7.3–9.0) | 7.3 (7.0–8.5) | 7.5 (6.9–7.7) | 7.5 (6.6–7.9) | 7.2 (6.8–7.7) |
| Visceral fat area (cm2) | 94.4 (58.8–159.0) | 99.5 (62.4–161.4) | 96.5 (63.9–148.9) | 100.2 (84.0–140.9) | 94.5 (76.5–148.5) | 103.3 (83.1–146.3) |
| Handgrip strength (kg) | 30.3 (23.6–35) | 30.1 (24.6–36.8) | 28.1 (26–33.9) | 31.1 (25.2–36.9) | 31.4 (25.7–35.8) | 33.2 (24.6–36.1) |
| Lower-extremity muscle strength (kg) | 32.4 (29.5–32.6) | 33.4 (30.2–34.2) | 32.9 (27.3–34) | 34.0 (25.3–37.6) | 37.4 (31.7–46.7)* | 35.7 (31.6–40.9) |
| 6-min walk test (m) | 460 (458–493) | 464 (460–485) | 490 (480–506) | 445 (420–480) | 490 (450–520)* | 496 (420–540)** |
| Transtheoretical model (precontemplation, contemplation, preparation, action or maintenance) (n = 12 in intervention group) | 1/1/2/1 | 1/2/1/1/ | 1/3/0/1 | 6/5/1/0 | 0/1/0/11* | 0/1/6/5** |
Wilcoxon’s signed-rank test was performed for within-group comparison of changes from week 0
Change from baseline was evaluated
*P < 0.01
**P < 0.05
On the other hand, in lower limb muscle strength of the intervention group, the significant difference observed at 8 weeks (from 34.0 (25.3–37.6) kg to 37.4 (31.7–46.7) kg, p = 0.005) disappeared after 2 years (35.7 (31.6–40.9) kg, p = 0.33).
Body mass index, HbA1c, skeletal muscle mass, body fat mass, visceral fat area, skeletal muscle mass index, and grip strength were not significantly different between week 8 and 2 years compared to baseline in both groups.
Discussion
This study was the long-term follow-up of changes in physical function in Japanese patients with T2D with and without short-term exercise instruction intervention by a physical therapist [7]. The results revealed that the intervention group maintained their behavioral change stage 2 years after the end of the exercise instruction intervention and maintained their 6 min walking distance.
Although the exercise therapy is one of the most important treatments for diabetes, about half of the patients did not practice exercise therapy [5]. Furthermore, 30% of patients with diabetes had never received exercise therapy instruction, and only 15% received instruction from the professional staff, including a physical therapist [5].
This study showed that even a short-term exercise instruction intervention by a physical therapist was able to maintain motivation and 6 min walking distance of the people with T2D over the following two years.
The possible reason why the intervention group was able to maintain a 6 min walking distance over the following 2 years might be followed. The previous randomized controlled study showed that physical therapists performing outpatients exercise instructions increased physical activity through improving motor performance and transtheoretical model [7]. Due to the small number of participants, there was no significant difference in the behaviour change stage at 2 years between the non-intervention group and the intervention group. However, the non-intervention group had a higher proportion of pre-contemplation and contemplation stages, whereas most participants in the intervention group tended to be remained in the preparation stage or later stages, which might be the reason why the intervention group was able to maintain their exercise habits. The transtheoretical model that was predominant at 8 weeks in the intervention group was maintained 2 years later, although it is unclear how much physical activity the intervention group maintained afterwards, because of no usage of activity meters in this study. In fact, a previous study of community-dwelling older adults reported that a 3 month exercise intervention was able to prevent long-term regression of exercise habits, indicating that the acquisition and maintenance of exercise habits are associated with improved physical function [14]. Furthermore, in this study, the dropout rate in the non-intervention group was higher than that in intervention group. The possible reason why the dropout rate in the non-intervention group was higher than that in intervention group is that the stage of behavior change. There was no significant difference of the stage of behavior change between the non-intervention and intervention groups due to the small number of participants. However, most participants in the intervention group remained in the preparatory stage or later, while most participants in the non-intervention group were in the pre-contemplation and contemplation stages of behavior change at 2 years. This suggests that the non-intervention group in the previous study may not have been able to maintain their motivation for exercise therapy, because of no exercise instruction. On the other hand, the intervention group may have been able to maintain their motivation for exercise and willing to participate in this study because they received specific exercise instruction.
Type 2 diabetes was reported to be an independent factor of decreases 6 min walking distance in the older [15] and people with heart failure [16]. It has been reported that 6 min walking distance in people with T2D decreased to 85% of that in healthy people [17]. In addition, there was negative correlation between 6 minute walking distance and HOMA-IR [18]. Furthermore, a previous study in people with dialysis reported that longer 6 min walking distance results in improving the risks of all- cause mortality and cardiovascular events [19]. Therefore, although there was no significant improvement in glycemic control in the intervention group in this study, maintaining the 6 min walking distance might be an important for maintaining good glycemic control and preventing further events.
On the other hand, the improvement in lower extremity muscle in the intervention group obtained at 8 weeks was lost at the 2 year follow-up. It has been reported that lower extremity muscle strength is affected by body fat percentage and lower extremity muscle strength has been reported to be lower with higher intramuscular fat content [20]. In addition, an association between increased intramuscular fat mass and decreased motor function, including lower extremity muscle strength, has been reported in the older and people with T2D [21–23]. The improvement in lower extremity muscle strength observed in the previous study [7] may have resulted from improvement in intramuscular fat due to increased physical activity. On the other hand, after 2 years, the decline was suppressive compared to the non-intervention group, but the effect disappeared, suggesting that sufficient physical activity might not have been maintained until lower limb muscle strength improved.
Limitation of this study should be mentioned. First, the relatively short duration of the previous study (8 weeks) allowed us to examine changes in various parameters with exercise instruction alone, without change of the medication. On the other hand, no restrictions were performed on change of the medication during the 2 years prior to this study, which may have influenced the results of the present study. Second, there is a possibility that selection bias may have affected the results of present study. Since the study participants were relatively small and the drop out of non- interventions groups were relatively high, although it was an observational study. Third, it would be desirable to use ambulatory accelerometers to accurately monitor the amount of physical activity, it is difficult to loan ambulatory accelerometers for two years because of material management, so we decided to use only the behavior change stage in this study.
In conclusion, short-term outpatient exercise instruction by physical therapists for patients with T2D may lead to long-term improvements in behaviour change towards exercise therapy and long-term maintenance of improved walking ability. On the other hand, the results suggest that further study for exercise instruction intervention is necessary to maintain and improve physical function, and good glycemic control.
Acknowledgements
None.
Author contributions
Conceptualization; YH, HO, HM and MF; Data curation; HI, TS, YH, HO, MH; Formal analysis; HI and YH; Funding acquisition; MF; Investigation; HI, TS, YH, JM and MH; Project administration; YH; Supervision; HO, HM and MF; Visualization; YH; Roles/Writing—original draft; HI; Writing—review & editing; TS, YH, JM, HO, HM, and MF.
Data availability
The data that support the findings of this study are available from the corresponding author, YH upon reasonable request.
Declarations
Conflict of interest
Dr Hashimoto received personal fees from Eli Lilly Japan K.K., Sanwa Kagaku Kenkyusho Co. Ltd, Novo Nordisk Pharma Ltd, Sanofi K.K., Nippon Boehringer Ingelheim Co. Ltd, Kowa Pharma Co. Ltd, Mitsubishi Tanabe Pharma Corp., and Taisho Pharma Co., Ltd, outside the submitted work. Dr Okada received personal fees from Sanofi K.K., Kissei Pharmaceutical Co., Ltd, Ono Pharmaceutical Co., Ltd., Eli Lilly Japan K.K, Novo Nordisk Pharma Ltd., Sumitomo Dainippon Pharma Co., Ltd., MSD K.K., Mitsubishi Tanabe Pharma Corp, Mochida Pharma Co. Ltd., Teijin Pharma Ltd., AstraZeneca K.K., Kowa Pharmaceutical Co., Ltd., Daiichi Sankyo Co., Ltd, Kyowa Hakko Kirin Company Ltd, and Takeda Pharmaceutical Co., Ltd. Dr. Murata received personal fees from Alexion pharmaceuticals inc. Prof. Fukui received grants from Sumitomo Dainippon Pharma Co., Ltd., Kowa Pharma Co., Ltd., Taisho Pharma Co., Ltd., Kissei Pharma Co., Ltd., Eli Lilly, Japan, K.K., Novo Nordisk Pharma Ltd., Sanofi K.K., Kyowa Kirin Co., Ltd., Sanwa Kagagu Kenkyusho CO., Ltd., Daiichi Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Ono Pharma Co., Ltd., Oishi Kenko Inc., Yamada Bee Farm, Terumo Corp., Mitsubishi Tanabe Pharma Corp., Takeda Pharma Co., Ltd., Astellas Pharma Inc., MSD K.K., Abbott Japan Co., Ltd., Tejin Pharma Ltd., Nippon Chemiphar Co., Ltd., and Johnson & Johnson K.K. Medical Co., and received personal fees from Sanwa Kagagu Kenkyusho CO., Ltd., Novo Nordisk Pharma Ltd., Daiichi Sankyo Co., Ltd., Nippon Boehringer Ingelheim Co., Ltd., Kyowa Kirin Co., Ltd., Sumitomo Dainippon Pharma Co., Ltd., MSD K.K., Kissei Pharma Co., Ltd., Sanofi K.K., Takeda Pharma Co., Ltd., Astellas Pharma Inc., Kowa Pharma Co., Ltd., Ono Pharma Co., Ltd., and Mitsubishi Tanabe Pharma Corp. outside of the submitted work. The other authors declare that they have no relevant financial interests.
Informed consent
Written informed consent was obtained from all participants.
Research involving human participants and/or animals
Human.
Human rights statement and informed consent
The study was approved by the local ethics committee of Matsushita Memorial Hospital (approval number: 22017, date of approval: Aug 18th 2022.) and conducted according to the principles of the Declaration of Helsinki.
Footnotes
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The data that support the findings of this study are available from the corresponding author, YH upon reasonable request.

