An interventional study of Aquatic walking exercise program group 1 and Aquatic walking exercise program group 2 in Peripheral Artery Disease, Vascular Function and Exercise Tolerance, sponsored by Pusan National University. Completed. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-11-03.
Sponsored by Pusan National University · Not applicable, Interventional, and Health services research
The purpose of this study was to examine the impacts of a 12-week aquatic walking exercise program on body composition, vascular function, cardiorespiratory capacity, exercise tolerance, muscular strength, and physical function in patients with peripheral artery disease (PAD). The effects of the 12-week aquatic walking exercise program were also compared to the effects of a 12-week land-based walking exercise program.
Exclusion Criteria:
No exercise intervention
The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks. The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking (forward, backward). The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity.
Other: Aquatic walking exercise program group 1
The aquatic walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks. The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of hip flexion-extension, hip abduction-adduction, and knee flexion-extension. The last 30 minutes included water walking (forward, backward). The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity.
Other: Aquatic walking exercise program group 2
The land-based walking exercise program was performed for 60 minutes per day, 4 times per week for 12 weeks. The program consisted of a warm-up (10 min) and cool-down (10 min) which included stretching and gait training. The 40-minute main exercise session included 10 minutes of low-intensity forward, backward, and lateral side-stepping movements on flat group. The remaining 30 minutes included treadmill walking exercise. The program intensity was established using heart rate reserve (HRR). Weeks 1-4 were at 50-60% HRR, weeks 5-8 were at 60-70% HRR, and weeks 9-12 were at 70-85% HRR. Subjects wore a heart rate monitor during the whole exercise training session in order to maintain the designated training intensity.
Other: Land-based walking exercise group
12 week aquatic walking exercise program
12 week aquatic walking exercise program
12 week land-based walking exercise program
Peripheral Arterial Stiffness
Peripheral arterial stiffness was estimated as measurement of femoral-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.
Time frame: 12 weeks
Body Composition
Body composition was measured using bioelectrical impedance analysis as percent body fat. A higher value represents a worse outcome. Scale range is approximately 10-35% for healthy populations.
Time frame: 12 weeks
Resting Heart Rate
Resting heart rate was measured as beats per minute (bpm). A higher value represents a worse outcome. Acceptable scale range is approximately 60-80 bpm for healthy populations.
Time frame: 12 weeks
Systolic Blood Pressure
Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129mmHg for most healthy populations.
Time frame: 12 weeks
Resting Metabolic Rate
Resting metabolic rate was measured as kilocalories per day. A higher value represents a better outcome. Scale range is approximately 1200-2200 kilocalories per day for healthy populations.
Time frame: 12 weeks
Cardiorespiratory Capacity
Cardiorespiratory capacity was measured as the volume of maximal oxygen consumption in milliliters per kilogram per minute (VO2max, mL/kg/min). A higher value represents a better outcome. Scale range is approximately 25-60 mL/kg/min for healthy populations.
Time frame: 12 weeks
Exercise Tolerance - Walking Capacity
Walking capacity was measured using the 6-minute walk test in meters. A higher value represents a better outcome. Scale range is approximately 400-1000 meters for healthy populations.
Time frame: 12 weeks
Upper Body Strength
Upper body strength was measured as hand grip strength in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-60kg for healthy populations.
Time frame: 12 weeks
Lower Body Strength
Lower body strength was measured with leg extension in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-120 kg for healthy populations.
Time frame: 12 weeks
Lower Body Flexibility
Lower body flexibility was measured using sit-and-reach in centimeters (cm). A higher value represents a better outcome. Scale range is approximately 10-30 cm for healthy populations.
Time frame: 12 weeks
Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function
The physical function domain score of the Medical Outcomes Study Short-Form 36 General Health Survey was measured. The scale range is from 0 to 100 percent. Higher scores represent a better outcome.
Time frame: 12 weeks
Diastolic Blood Pressure
Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for diastolic blood pressure is approximately 70-79 mmHg for most healthy populations.
Time frame: 12 weeks
Systemic Arterial Stiffness
Systemic arterial stiffness was estimated as measurement of brachial-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.
Time frame: 12 weeks
Time to Onset of Claudication
Time to onset of claudication was measured during the 6-minute walking distance test (seconds). A higher value represents a better outcome. Healthy populations can typically walk the entire 6 minutes (360 seconds) without experiencing claudication.
Time frame: 12 weeks
| Milestone | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Started | 42 | 42 | 32 | 31 |
| Completed | 37 | 35 | 28 | 25 |
| Not completed | 5 | 7 | 4 | 6 |
| Withdrew: Move out to different area | 1 | 3 | 1 | 4 |
| Withdrew: Scheduling/transportation conflict | 4 | 4 | 3 | 2 |
Peripheral arterial stiffness was estimated as measurement of femoral-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.
| meters per second | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Peripheral Arterial Stiffness | 12.3 ± 1.1 | 10.2 ± .9 | 12.4 ± 1.2 | 12.8 ± 1.4 |
Body composition was measured using bioelectrical impedance analysis as percent body fat. A higher value represents a worse outcome. Scale range is approximately 10-35% for healthy populations.
| body fat percentage (%) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Body Composition | 30.5 ± 5.2 | 28.5 ± 3.9 | 28.5 ± 5.2 | 28.7 ± 6.1 |
Resting heart rate was measured as beats per minute (bpm). A higher value represents a worse outcome. Acceptable scale range is approximately 60-80 bpm for healthy populations.
| beats per minute | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Resting Heart Rate | 70.2 ± 10 | 67.9 ± 9 | 71 ± 5 | 71 ± 7 |
Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for systolic blood pressure is approximately 110-129mmHg for most healthy populations.
| millimeters of mercury | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Systolic Blood Pressure | 132.4 ± 9 | 130.4 ± 8.2 | 126 ± 9 | 129 ± 10 |
Resting metabolic rate was measured as kilocalories per day. A higher value represents a better outcome. Scale range is approximately 1200-2200 kilocalories per day for healthy populations.
| kilocalories per day | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Resting Metabolic Rate | 1022.9 ± 44.2 | 1021.5 ± 40.5 | 1282 ± 43 | 1272 ± 35 |
Cardiorespiratory capacity was measured as the volume of maximal oxygen consumption in milliliters per kilogram per minute (VO2max, mL/kg/min). A higher value represents a better outcome. Scale range is approximately 25-60 mL/kg/min for healthy populations.
| milliliters/kilogram/minute of oxygen | Control Group | Aquatic Walking Exercise Group 1 |
|---|---|---|
| Cardiorespiratory Capacity | 17.8 ± 5.3 | 20.5 ± 5.2 |
Walking capacity was measured using the 6-minute walk test in meters. A higher value represents a better outcome. Scale range is approximately 400-1000 meters for healthy populations.
| meters | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Exercise Tolerance - Walking Capacity | 358 ± 92 | 440 ± 88 | 438 ± 97 | 404 ± 101 |
Upper body strength was measured as hand grip strength in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-60kg for healthy populations.
| kilograms | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Upper Body Strength | 25.1 ± 1.2 | 26 ± 3.7 | 26 ± 3 | 27 ± 5 |
Lower body strength was measured with leg extension in kilograms (kg). A higher value represents a better outcome. Scale range is approximately 20-120 kg for healthy populations.
| kilograms | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Lower Body Strength | 45.2 ± 12.1 | 47.3 ± 20.9 | 48 ± 13 | 46 ± 11 |
Lower body flexibility was measured using sit-and-reach in centimeters (cm). A higher value represents a better outcome. Scale range is approximately 10-30 cm for healthy populations.
| centimeters | Control Group | Aquatic Walking Exercise Group 1 |
|---|---|---|
| Lower Body Flexibility | 15.2 ± 3.3 | 15.9 ± 6.3 |
The physical function domain score of the Medical Outcomes Study Short-Form 36 General Health Survey was measured. The scale range is from 0 to 100 percent. Higher scores represent a better outcome.
| score in percents | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 46 ± 21 | 52 ± 31 | 55 ± 27 | 53 ± 25 |
Blood pressure was measured as millimeters of mercury (mmHg). Higher values represent a worse outcome. Scale range for diastolic blood pressure is approximately 70-79 mmHg for most healthy populations.
| millimeters of mercury | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Exercise Group |
|---|---|---|---|---|
| Diastolic Blood Pressure | 90.7 ± 11 | 82.7 ± 10 | 84 ± 8 | 85 ± 10 |
Systemic arterial stiffness was estimated as measurement of brachial-to-ankle pulse wave velocity (meters per second). A higher value represents a worse outcome. Scale range is approximately 7.0 - 14.0 meters per second for healthy populations.
| meters per second | Aquatic Walking Exercise Group 2 | Land-based Exercise Walking Group |
|---|---|---|
| Systemic Arterial Stiffness | 14.7 ± 1.9 | 14.8 ± 2.0 |
Time to onset of claudication was measured during the 6-minute walking distance test (seconds). A higher value represents a better outcome. Healthy populations can typically walk the entire 6 minutes (360 seconds) without experiencing claudication.
| seconds | Aquatic Walking Exercise Group 2 | Land-based Exercise Walking Group |
|---|---|---|
| Time to Onset of Claudication | 252 ± 101 | 213 ± 99 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Aquatic Walking Exercise Group 1 | 0/42 (0%) | 0/42 (0%) | 0/42 (0%) |
| Aquatic Walking Exercise Group 2 | 0/32 (0%) | 0/32 (0%) | 0/32 (0%) |
| Land-based Walking Group | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 13 | 14 | 27 |
| >=65 years | 42 | 42 | 19 | 17 | 120 |
| Age, Continuous(years) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Total |
|---|---|---|---|---|---|
| Mean | 71 ± 8 | 70 ± 10 | 70 ± 10 | 70 ± 10 | 70.1 ± 9.8 |
| Sex: Female, Male(Participants) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Total |
|---|---|---|---|---|---|
| Female | 42 | 42 | 32 | 31 | 147 |
| Male | 0 | 0 | 0 | 0 | 0 |
| Race and Ethnicity Not Collected(Participants) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
| Region of Enrollment(Participants) | Control Group | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Total |
|---|---|---|---|---|---|
| South Korea | 42 | 42 | 32 | 31 | 147 |
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Pusan National University