NCT03849300

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

Completed NA Results posted Last updated 3 November 2020

What this trial tests

NA trial testing Aquatic walking exercise program group 1 in Peripheral Artery Disease in 147 participants. Completed in 4 February 2019.

Timeline

9 May 2010

Primary endpoint
8 August 2017

4 February 2019

Quick facts

Lead sponsor	Pusan National University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	health services research
Enrollment	147
Start date	9 May 2010
Primary completion	8 August 2017
Estimated completion	4 February 2019

Drugs / interventions tested

• Aquatic walking exercise program group 1
• Aquatic walking exercise program group 2
• Land-based walking exercise group

Conditions studied

• Peripheral Artery Disease — all drugs for Peripheral Artery Disease →
• Vascular Function — all drugs for Vascular Function →
• Exercise Tolerance — all drugs for Exercise Tolerance →
• Peripheral Arterial Disease — all drugs for Peripheral Arterial Disease →

Sponsor

Pusan National University

Who can join

Adults 50 to 85, any sex, with Peripheral Artery Disease or Vascular Function. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Peripheral Arterial Stiffness Primary · 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.

Group	Value	95% CI
Control Group	12.3	± 1.1
Aquatic Walking Exercise Group 1	10.2	± .9
Aquatic Walking Exercise Group 2	12.4	± 1.2
Land-based Walking Exercise Group	12.8	± 1.4

Body Composition Secondary · 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.

Group	Value	95% CI
Control Group	30.5	± 5.2
Aquatic Walking Exercise Group 1	28.5	± 3.9
Aquatic Walking Exercise Group 2	28.5	± 5.2
Land-based Walking Exercise Group	28.7	± 6.1

Resting Heart Rate Secondary · 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.

Group	Value	95% CI
Control Group	70.2	± 10
Aquatic Walking Exercise Group 1	67.9	± 9
Aquatic Walking Exercise Group 2	71	± 5
Land-based Walking Exercise Group	71	± 7

Systolic Blood Pressure Secondary · 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.

Group	Value	95% CI
Control Group	132.4	± 9
Aquatic Walking Exercise Group 1	130.4	± 8.2
Aquatic Walking Exercise Group 2	126	± 9
Land-based Walking Exercise Group	129	± 10

Resting Metabolic Rate Secondary · 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.

Group	Value	95% CI
Control Group	1022.9	± 44.2
Aquatic Walking Exercise Group 1	1021.5	± 40.5
Aquatic Walking Exercise Group 2	1282	± 43
Land-based Walking Exercise Group	1272	± 35

Cardiorespiratory Capacity Secondary · 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.

Group	Value	95% CI
Control Group	17.8	± 5.3
Aquatic Walking Exercise Group 1	20.5	± 5.2

Exercise Tolerance - Walking Capacity Secondary · 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.

Group	Value	95% CI
Control Group	358	± 92
Aquatic Walking Exercise Group 1	440	± 88
Aquatic Walking Exercise Group 2	438	± 97
Land-based Walking Exercise Group	404	± 101

Upper Body Strength Secondary · 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.

Group	Value	95% CI
Control Group	25.1	± 1.2
Aquatic Walking Exercise Group 1	26	± 3.7
Aquatic Walking Exercise Group 2	26	± 3
Land-based Walking Exercise Group	27	± 5

Lower Body Strength Secondary · 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.

Group	Value	95% CI
Control Group	45.2	± 12.1
Aquatic Walking Exercise Group 1	47.3	± 20.9
Aquatic Walking Exercise Group 2	48	± 13
Land-based Walking Exercise Group	46	± 11

Lower Body Flexibility Secondary · 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.

Group	Value	95% CI
Control Group	15.2	± 3.3
Aquatic Walking Exercise Group 1	15.9	± 6.3

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

Group	Value	95% CI
Control Group	46	± 21
Aquatic Walking Exercise Group 1	52	± 31
Aquatic Walking Exercise Group 2	55	± 27
Land-based Walking Exercise Group	53	± 25

Diastolic Blood Pressure Secondary · 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.

Group	Value	95% CI
Control Group	90.7	± 11
Aquatic Walking Exercise Group 1	82.7	± 10
Aquatic Walking Exercise Group 2	84	± 8
Land-based Walking Exercise Group	85	± 10

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.