Exercise Tolerance, Peripheral Arterial Disease, Peripheral Artery Disease, Vascular Function
Conditions
Keywords
arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max
Brief summary
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.
Interventions
OTHERAquatic walking exercise program group 1
12 week aquatic walking exercise program
OTHERAquatic walking exercise program group 2
12 week aquatic walking exercise program
OTHERLand-based walking exercise group
12 week land-based walking exercise program
Sponsors
Marymount University
Dong-Eui University
Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Peripheral Arterial Stiffness | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Resting Heart Rate | 12 weeks | 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. |
| Systolic Blood Pressure | 12 weeks | 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. |
| Resting Metabolic Rate | 12 weeks | 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. |
| Cardiorespiratory Capacity | 12 weeks | 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. |
| Exercise Tolerance - Walking Capacity | 12 weeks | 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. |
| Upper Body Strength | 12 weeks | 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. |
| Body Composition | 12 weeks | 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. |
| Lower Body Flexibility | 12 weeks | 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. |
| Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 12 weeks | 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. |
| Diastolic Blood Pressure | 12 weeks | 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. |
| Systemic Arterial Stiffness | 12 weeks | 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 to Onset of Claudication | 12 weeks | 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. |
| Lower Body Strength | 12 weeks | 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group No exercise intervention | 42 |
| Aquatic Walking Exercise 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 exercise (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. | 42 |
| Aquatic Walking Exercise Group 2 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 exercise (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. | 32 |
| Land-based Walking Group 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. | 31 |
| Total | 147 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | move out to different area | 1 | 3 | 1 | 4 |
| Overall Study | scheduling/transportation conflict | 4 | 4 | 3 | 2 |
Baseline characteristics
| Characteristic | Aquatic Walking Exercise Group 1 | Aquatic Walking Exercise Group 2 | Land-based Walking Group | Control Group | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 42 Participants | 19 Participants | 17 Participants | 42 Participants | 120 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 13 Participants | 14 Participants | 0 Participants | 27 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 10 | 70 years STANDARD_DEVIATION 10 | 70 years STANDARD_DEVIATION 10 | 71 years STANDARD_DEVIATION 8 | 70.1 years STANDARD_DEVIATION 9.8 |
| Race and Ethnicity Not Collected | — | — | — | — | 0 Participants |
| Region of Enrollment South Korea | 42 Participants | 32 Participants | 31 Participants | 42 Participants | 147 Participants |
| Sex: Female, Male Female | 42 Participants | 32 Participants | 31 Participants | 42 Participants | 147 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 0 / 32 | 0 / 31 |
| other Total, other adverse events | 0 / 42 | 0 / 42 | 0 / 32 | 0 / 31 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 32 | 0 / 31 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Peripheral Arterial Stiffness | 12.3 meters per second | Standard Deviation 1.1 |
| Aquatic Walking Exercise Group 1 | Peripheral Arterial Stiffness | 10.2 meters per second | Standard Deviation 0.9 |
| Aquatic Walking Exercise Group 2 | Peripheral Arterial Stiffness | 12.4 meters per second | Standard Deviation 1.2 |
| Land-based Walking Exercise Group | Peripheral Arterial Stiffness | 12.8 meters per second | Standard Deviation 1.4 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Body Composition | 30.5 body fat percentage (%) | Standard Deviation 5.2 |
| Aquatic Walking Exercise Group 1 | Body Composition | 28.5 body fat percentage (%) | Standard Deviation 3.9 |
| Aquatic Walking Exercise Group 2 | Body Composition | 28.5 body fat percentage (%) | Standard Deviation 5.2 |
| Land-based Walking Exercise Group | Body Composition | 28.7 body fat percentage (%) | Standard Deviation 6.1 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Cardiorespiratory Capacity | 17.8 milliliters/kilogram/minute of oxygen | Standard Deviation 5.3 |
| Aquatic Walking Exercise Group 1 | Cardiorespiratory Capacity | 20.5 milliliters/kilogram/minute of oxygen | Standard Deviation 5.2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Diastolic Blood Pressure | 90.7 millimeters of mercury | Standard Deviation 11 |
| Aquatic Walking Exercise Group 1 | Diastolic Blood Pressure | 82.7 millimeters of mercury | Standard Deviation 10 |
| Aquatic Walking Exercise Group 2 | Diastolic Blood Pressure | 84 millimeters of mercury | Standard Deviation 8 |
| Land-based Walking Exercise Group | Diastolic Blood Pressure | 85 millimeters of mercury | Standard Deviation 10 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Exercise Tolerance - Walking Capacity | 358 meters | Standard Deviation 92 |
| Aquatic Walking Exercise Group 1 | Exercise Tolerance - Walking Capacity | 440 meters | Standard Deviation 88 |
| Aquatic Walking Exercise Group 2 | Exercise Tolerance - Walking Capacity | 438 meters | Standard Deviation 97 |
| Land-based Walking Exercise Group | Exercise Tolerance - Walking Capacity | 404 meters | Standard Deviation 101 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Lower Body Flexibility | 15.2 centimeters | Standard Deviation 3.3 |
| Aquatic Walking Exercise Group 1 | Lower Body Flexibility | 15.9 centimeters | Standard Deviation 6.3 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Lower Body Strength | 45.2 kilograms | Standard Deviation 12.1 |
| Aquatic Walking Exercise Group 1 | Lower Body Strength | 47.3 kilograms | Standard Deviation 20.9 |
| Aquatic Walking Exercise Group 2 | Lower Body Strength | 48 kilograms | Standard Deviation 13 |
| Land-based Walking Exercise Group | Lower Body Strength | 46 kilograms | Standard Deviation 11 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 46 score in percents | Standard Deviation 21 |
| Aquatic Walking Exercise Group 1 | Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 52 score in percents | Standard Deviation 31 |
| Aquatic Walking Exercise Group 2 | Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 55 score in percents | Standard Deviation 27 |
| Land-based Walking Exercise Group | Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function | 53 score in percents | Standard Deviation 25 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Resting Heart Rate | 70.2 beats per minute | Standard Deviation 10 |
| Aquatic Walking Exercise Group 1 | Resting Heart Rate | 67.9 beats per minute | Standard Deviation 9 |
| Aquatic Walking Exercise Group 2 | Resting Heart Rate | 71 beats per minute | Standard Deviation 5 |
| Land-based Walking Exercise Group | Resting Heart Rate | 71 beats per minute | Standard Deviation 7 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Resting Metabolic Rate | 1022.9 kilocalories per day | Standard Deviation 44.2 |
| Aquatic Walking Exercise Group 1 | Resting Metabolic Rate | 1021.5 kilocalories per day | Standard Deviation 40.5 |
| Aquatic Walking Exercise Group 2 | Resting Metabolic Rate | 1282 kilocalories per day | Standard Deviation 43 |
| Land-based Walking Exercise Group | Resting Metabolic Rate | 1272 kilocalories per day | Standard Deviation 35 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Systemic Arterial Stiffness | 14.7 meters per second | Standard Deviation 1.9 |
| Aquatic Walking Exercise Group 1 | Systemic Arterial Stiffness | 14.8 meters per second | Standard Deviation 2 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Systolic Blood Pressure | 132.4 millimeters of mercury | Standard Deviation 9 |
| Aquatic Walking Exercise Group 1 | Systolic Blood Pressure | 130.4 millimeters of mercury | Standard Deviation 8.2 |
| Aquatic Walking Exercise Group 2 | Systolic Blood Pressure | 126 millimeters of mercury | Standard Deviation 9 |
| Land-based Walking Exercise Group | Systolic Blood Pressure | 129 millimeters of mercury | Standard Deviation 10 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Time to Onset of Claudication | 252 seconds | Standard Deviation 101 |
| Aquatic Walking Exercise Group 1 | Time to Onset of Claudication | 213 seconds | Standard Deviation 99 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control Group | Upper Body Strength | 25.1 kilograms | Standard Deviation 1.2 |
| Aquatic Walking Exercise Group 1 | Upper Body Strength | 26 kilograms | Standard Deviation 3.7 |
| Aquatic Walking Exercise Group 2 | Upper Body Strength | 26 kilograms | Standard Deviation 3 |
| Land-based Walking Exercise Group | Upper Body Strength | 27 kilograms | Standard Deviation 5 |