CClinicalTrials.gg
CompletedNCT03849300Updated Nov 3, 2020Results posted

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

An interventional study of Aquatic walking exercise program group 1 and Aquatic walking exercise program group 2 in Peripheral Artery Disease, Vascular Function and Exercise Tolerance, sponsored by Pusan National University. Completed. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-11-03.

Sponsored by Pusan National University · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
147
Allocation
Randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.

02

Conditions studied

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

Keywords

  • arterial stiffness
  • cardiorespiratory capacity
  • exercise tolerance
  • VO2max
03

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • current smoker (smoking within previous 6 months)
  • psychiatric conditions
  • pulmonary disease
  • renal disease
  • thyroid disease
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
147 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • OtherAquatic walking exercise program group 1

    12 week aquatic walking exercise program

  • OtherAquatic walking exercise program group 2

    12 week aquatic walking exercise program

  • OtherLand-based walking exercise group

    12 week land-based walking exercise program

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

Secondary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: 12 weeks

  3. 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.

    Time frame: 12 weeks

  4. 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.

    Time frame: 12 weeks

  5. 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.

    Time frame: 12 weeks

  6. 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.

    Time frame: 12 weeks

  7. 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.

    Time frame: 12 weeks

  8. 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.

    Time frame: 12 weeks

  9. 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.

    Time frame: 12 weeks

  10. 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.

    Time frame: 12 weeks

  11. 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.

    Time frame: 12 weeks

  12. 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 frame: 12 weeks

  13. 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.

    Time frame: 12 weeks

06

Results

Posted Mar 9, 2020

Participant flow

Participant flow — Overall Study
MilestoneControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Started42423231
Completed37352825
Not completed5746
Withdrew: Move out to different area1314
Withdrew: Scheduling/transportation conflict4432

Outcome measures

PrimaryPeripheral 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.

Time frame:
12 weeks
Reported as:
Mean · meters per second
Peripheral Arterial Stiffness
meters per secondControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Peripheral Arterial Stiffness12.3 ± 1.110.2 ± .912.4 ± 1.212.8 ± 1.4
SecondaryBody 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.

Time frame:
12 weeks
Reported as:
Mean · body fat percentage (%)
Body Composition
body fat percentage (%)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Body Composition30.5 ± 5.228.5 ± 3.928.5 ± 5.228.7 ± 6.1
SecondaryResting 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.

Time frame:
12 weeks
Reported as:
Mean · beats per minute
Resting Heart Rate
beats per minuteControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Resting Heart Rate70.2 ± 1067.9 ± 971 ± 571 ± 7
SecondarySystolic 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.

Time frame:
12 weeks
Reported as:
Mean · millimeters of mercury
Systolic Blood Pressure
millimeters of mercuryControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Systolic Blood Pressure132.4 ± 9130.4 ± 8.2126 ± 9129 ± 10
SecondaryResting 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.

Time frame:
12 weeks
Reported as:
Mean · kilocalories per day
Resting Metabolic Rate
kilocalories per dayControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Resting Metabolic Rate1022.9 ± 44.21021.5 ± 40.51282 ± 431272 ± 35
SecondaryCardiorespiratory 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.

Time frame:
12 weeks
Reported as:
Mean · milliliters/kilogram/minute of oxygen
Cardiorespiratory Capacity
milliliters/kilogram/minute of oxygenControl GroupAquatic Walking Exercise Group 1
Cardiorespiratory Capacity17.8 ± 5.320.5 ± 5.2
SecondaryExercise 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.

Time frame:
12 weeks
Reported as:
Mean · meters
Exercise Tolerance - Walking Capacity
metersControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Exercise Tolerance - Walking Capacity358 ± 92440 ± 88438 ± 97404 ± 101
SecondaryUpper 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.

Time frame:
12 weeks
Reported as:
Mean · kilograms
Upper Body Strength
kilogramsControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Upper Body Strength25.1 ± 1.226 ± 3.726 ± 327 ± 5
SecondaryLower 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.

Time frame:
12 weeks
Reported as:
Mean · kilograms
Lower Body Strength
kilogramsControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Lower Body Strength45.2 ± 12.147.3 ± 20.948 ± 1346 ± 11
SecondaryLower 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.

Time frame:
12 weeks
Reported as:
Mean · centimeters
Lower Body Flexibility
centimetersControl GroupAquatic Walking Exercise Group 1
Lower Body Flexibility15.2 ± 3.315.9 ± 6.3
SecondaryMedical 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.

Time frame:
12 weeks
Reported as:
Mean · score in percents
Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function
score in percentsControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function46 ± 2152 ± 3155 ± 2753 ± 25
SecondaryDiastolic 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.

Time frame:
12 weeks
Reported as:
Mean · millimeters of mercury
Diastolic Blood Pressure
millimeters of mercuryControl GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking Exercise Group
Diastolic Blood Pressure90.7 ± 1182.7 ± 1084 ± 885 ± 10
SecondarySystemic 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 frame:
12 weeks
Reported as:
Mean · meters per second
Systemic Arterial Stiffness
meters per secondAquatic Walking Exercise Group 2Land-based Exercise Walking Group
Systemic Arterial Stiffness14.7 ± 1.914.8 ± 2.0
SecondaryTime 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.

Time frame:
12 weeks
Reported as:
Mean · seconds
Time to Onset of Claudication
secondsAquatic Walking Exercise Group 2Land-based Exercise Walking Group
Time to Onset of Claudication252 ± 101213 ± 99

Adverse events

Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control Group0/42 (0%)0/42 (0%)0/42 (0%)
Aquatic Walking Exercise Group 10/42 (0%)0/42 (0%)0/42 (0%)
Aquatic Walking Exercise Group 20/32 (0%)0/32 (0%)0/32 (0%)
Land-based Walking Group0/31 (0%)0/31 (0%)0/31 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking GroupTotal
<=18 years00000
Between 18 and 65 years00131427
>=65 years42421917120
Age, Continuous
Age, Continuous(years)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking GroupTotal
Mean71 ± 870 ± 1070 ± 1070 ± 1070.1 ± 9.8
Sex: Female, Male
Sex: Female, Male(Participants)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking GroupTotal
Female42423231147
Male00000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking GroupTotal
Count of participants————0
Region of Enrollment
Region of Enrollment(Participants)Control GroupAquatic Walking Exercise Group 1Aquatic Walking Exercise Group 2Land-based Walking GroupTotal
South Korea42423231147
07

Study locations

No study locations are listed for this record.

08

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 5, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

09

Registry details

Key details

Study ID
NCT03849300
Lead sponsor
Pusan National University
Collaborators
Marymount University, Dong-Eui University
Responsible party
Won-mok son (Principal Investigator, Pusan National University) — Principal investigator
First posted
Feb 21, 2019
Start date
May 9, 2010
Primary completion
Aug 8, 2017
Completion
Feb 4, 2019
Results posted
Mar 9, 2020
Last update
Nov 3, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion