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

Primary Purpose

Peripheral Artery Disease, Vascular Function, Exercise Tolerance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Aquatic walking exercise program group 1
Aquatic walking exercise program group 2
Land-based walking exercise group
Sponsored by
Pusan National University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Peripheral Artery Disease focused on measuring arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Control Group

    Aquatic walking exercise group 1

    Aquatic walking exercise group 2

    Land-based walking exercise group

    Arm Description

    No exercise intervention

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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.
    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 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.

    Full Information

    First Posted
    February 19, 2019
    Last Updated
    October 30, 2020
    Sponsor
    Pusan National University
    Collaborators
    Marymount University, Dong-Eui University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03849300
    Brief Title
    Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    May 9, 2010 (Actual)
    Primary Completion Date
    August 8, 2017 (Actual)
    Study Completion Date
    February 4, 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Pusan National University
    Collaborators
    Marymount University, Dong-Eui University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Peripheral Artery Disease, Vascular Function, Exercise Tolerance, Peripheral Arterial Disease
    Keywords
    arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    147 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Control Group
    Arm Type
    No Intervention
    Arm Description
    No exercise intervention
    Arm Title
    Aquatic walking exercise group 1
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Aquatic walking exercise group 2
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Land-based walking exercise group
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Aquatic walking exercise program group 1
    Intervention Description
    12 week aquatic walking exercise program
    Intervention Type
    Other
    Intervention Name(s)
    Aquatic walking exercise program group 2
    Intervention Description
    12 week aquatic walking exercise program
    Intervention Type
    Other
    Intervention Name(s)
    Land-based walking exercise group
    Intervention Description
    12 week land-based walking exercise program
    Primary Outcome Measure Information:
    Title
    Peripheral Arterial Stiffness
    Description
    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
    Secondary Outcome Measure Information:
    Title
    Body Composition
    Description
    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
    Title
    Resting Heart Rate
    Description
    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
    Title
    Systolic Blood Pressure
    Description
    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
    Title
    Resting Metabolic Rate
    Description
    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
    Title
    Cardiorespiratory Capacity
    Description
    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
    Title
    Exercise Tolerance - Walking Capacity
    Description
    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
    Title
    Upper Body Strength
    Description
    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
    Title
    Lower Body Strength
    Description
    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
    Title
    Lower Body Flexibility
    Description
    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
    Title
    Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function
    Description
    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
    Title
    Diastolic Blood Pressure
    Description
    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
    Title
    Systemic Arterial Stiffness
    Description
    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
    Title
    Time to Onset of Claudication
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    85 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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