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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral Arterial Disease; Peripheral Artery Disease; Vascular Function; Exercise Tolerance
• Intervention / Treatment: Other: Aquatic walking exercise program group 1; Other: Aquatic walking exercise program group 2; Other: Land-based walking exercise group

• Study Type: Interventional
• Enrollment (Actual): 147
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; No exercise intervention
Experimental: 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 (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; 12 week aquatic walking exercise program
Experimental: 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 (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; 12 week aquatic walking exercise program
Active Comparator: Land-based walking exercise 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.	Other: Land-based walking exercise group; 12 week land-based walking exercise program

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pusan National University
• Collaborators: Marymount University; Dong-Eui University

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2010
• Primary Completion (Actual): August 8, 2017
• Study Completion (Actual): February 4, 2019

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 19, 2019
• First Posted (Actual): February 21, 2019

Study Record Updates

• Last Update Posted (Actual): November 3, 2020
• Last Update Submitted That Met QC Criteria: October 30, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: exercise tolerance; VO2max; arterial stiffness; cardiorespiratory capacity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Peripheral Arterial Disease; Peripheral Vascular Diseases
• Other Study ID Numbers: UNOmaha5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No