Hartmann 1997.
Methods |
Aim: To determine the potential long‐term effects of a programme of combined physical therapy consisting of exercises, external compression and brief cold stimuli on venous circulation in the legs and on participants' symptoms Duration of participation: 24 weeks Frequency of intervention: 2 days/week Inclusion criteria: Individuals suffering from manifest varicose veins in both lower extremities with increased venous capacity, as determined by strain‐gauge plethysmography (SGP), and reduced venous filling time as determined by photoplethysmography Exclusion criteria: Concomitant heart or arterial disease, orthopaedic disorders of the lower extremities, or vasoactive medication |
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Participants |
Total no. randomised: 24 (intervention = 12; control = 11 + 1 dropout) Age: 31 to 71 years (mean ± SD: 54.7 ± 3.2) Gender: 17 women, 7 men Severity of disease: not reported |
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Interventions |
Intervention: 60 minutes of exercise (2 days per week), first 20 minutes in an exercise bath (water level 135 cm, hydrostatic pressure 100 mmHg, water temperature 34ºC), then the legs were doused with cold water for 30 seconds and followed by 25 minutes of floor exercises. The exercises were designed to improve breathing and the efficiency of muscle and joint pumps Co‐interventions: Compression stockings (30 mmHg) during exercises. Unsupervised exercise once a day for 15 minutes |
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Outcomes |
Outcomes relevant for this review Primary outcomes: 1. Intensity of disease signs and symptoms: The authors used a non‐validated tool 2. Ejection fraction: Not reported 3. Venous refilling time (mean ± SD): Increased in the treatment group. After treatment, half refilling time was 11.3 ± 0.9 seconds in the intervention group compared with 7.1 ± 1.3 seconds in the control group (P < 0.001). Total refilling time in intervention group was 25.7 ± 2.1 compared with 16.3 ± 1.9 (P < 0.001) in the control group 4. Incidence of venous leg ulcer: Not reported Secondary outcomes: 1. Quality of life: Not reported 2. Exercise capacity: Not reported 3. Muscle strength: Not reported 4. Incidence of surgical intervention to treat symptoms related to CVI: Not reported 5. Ankle joint mobility: Not reported |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | "After receiving detailed information about test procedures, they were randomized into two groups. For the purpose of the study these two groups formed matched pairs, corresponding to one another in all relevant measurement parameters". There is no mention on how they were matched. |
Allocation concealment (selection bias) | High risk | "After receiving detailed information about test procedures, they were randomized into two groups. For the purpose of the study these two groups formed matched pairs, corresponding to one another in all relevant measurement parameters" |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | The authors do not mention if there was blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | The authors do not mention blinding of outcome assessment |
Incomplete outcome data (attrition bias) All outcomes | High risk | "During the study there was 1 dropout from the control group who declined to submit to further control measurements" |
Selective reporting (reporting bias) | High risk | In the measurement section of the study report, the study authors say, "After a fifteen minute rest period, two measurements each of venous capacity and maximum venous outflow were made at intervals of five minutes by means of a strain‐gauge plethysmograph". But there are no reports of maximum venous outflow |
Other bias | High risk | Unit of analysis are extremities and not subjects |