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

Peripheral Arterial Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03849300
• Other study ID #: UNOmaha5
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Exercise Tolerance
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Diseases
• Vascular Function

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