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Completed

NCT Number: NCT03849300

Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance 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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aquatic walking exercise program group 1

Other

12 week aquatic walking exercise program

Aquatic walking exercise program group 2

Other

12 week aquatic walking exercise program

Land-based walking exercise group

Other

12 week land-based walking exercise program

Primary outcomes

  1. Peripheral Arterial Stiffness

    Time frame: 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 outcomes

  1. Body Composition

    Time frame: 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.

  2. Resting Heart Rate

    Time frame: 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.

  3. Systolic Blood Pressure

    Time frame: 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.

  4. Resting Metabolic Rate

    Time frame: 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.

  5. Cardiorespiratory Capacity

    Time frame: 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.

  6. Exercise Tolerance - Walking Capacity

    Time frame: 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.

  7. Upper Body Strength

    Time frame: 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.

  8. Lower Body Strength

    Time frame: 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.

  9. Lower Body Flexibility

    Time frame: 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.

  10. Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function

    Time frame: 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.

  11. Diastolic Blood Pressure

    Time frame: 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.

  12. Systemic Arterial Stiffness

    Time frame: 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.

  13. Time to Onset of Claudication

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pusan National University

Other

Collaborators

  • Dong-Eui University
  • Marymount University

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2017
Study completion
2019
First posted
Feb 21, 2019
Registry last updated
Nov 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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