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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03849300
Other study ID # UNOmaha5
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 9, 2010
Est. completion date February 4, 2019

Study information

Verified date October 2020
Source Pusan National University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 147
Est. completion date February 4, 2019
Est. primary completion date August 8, 2017
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Aquatic walking exercise program group 1
12 week aquatic walking exercise program
Aquatic walking exercise program group 2
12 week aquatic walking exercise program
Land-based walking exercise group
12 week land-based walking exercise program

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Pusan National University Dong-Eui University, Marymount University

Outcome

Type Measure Description Time frame Safety issue
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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. 12 weeks
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