Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease

Study Overview
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Brief Summary
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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.

Official Title
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The Impacts of Aquatic Walking and Land-based Walking Exercise Therapy Programs on Vascular Function, Cardiorespiratory Capacity, Exercise Tolerance, Muscular Strength, and Physical Function in Patients With Peripheral Artery Disease

Conditions
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Peripheral Artery Disease, Vascular Function, Exercise Tolerance, Peripheral Arterial Disease

Intervention / Treatment
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* Other: Aquatic walking exercise program group 1
* Other: Aquatic walking exercise program group 2
* Other: Land-based walking exercise group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Peripheral artery disease (ankle-brachial index between 0.6 and 0.9) 50-85 years of age Sedentary (less than 1 hour of regular exercise participation per week within the previous year) Exclusion Criteria: current smoker (smoking within previous 6 months) psychiatric conditions pulmonary disease renal disease thyroid disease

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>No exercise intervention | |
| Experimental: Aquatic walking exercise group 1<br>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<br>* 12 week aquatic walking exercise program<br>|
| Experimental: Aquatic walking exercise group 2<br>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<br>* 12 week aquatic walking exercise program<br>|
| Active Comparator: Land-based walking exercise group<br>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<br>* 12 week land-based walking exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max