NCT03849300

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2010

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 9, 2010

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2017

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 19, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
1 year until next milestone

Results Posted

Study results publicly available

March 9, 2020

Completed
Last Updated

November 3, 2020

Status Verified

October 1, 2020

Enrollment Period

7.3 years

First QC Date

February 19, 2019

Results QC Date

February 5, 2020

Last Update Submit

October 30, 2020

Conditions

Keywords

arterial stiffnesscardiorespiratory capacityexercise toleranceVO2max

Outcome Measures

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.

    12 weeks

Secondary Outcomes (13)

  • Body Composition

    12 weeks

  • Resting Heart Rate

    12 weeks

  • Systolic Blood Pressure

    12 weeks

  • Resting Metabolic Rate

    12 weeks

  • Cardiorespiratory Capacity

    12 weeks

  • +8 more secondary outcomes

Study Arms (4)

Control Group

NO INTERVENTION

No exercise intervention

Aquatic walking exercise group 1

EXPERIMENTAL

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

Aquatic walking exercise group 2

EXPERIMENTAL

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

Land-based walking exercise group

ACTIVE COMPARATOR

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

12 week aquatic walking exercise program

Aquatic walking exercise group 1

12 week aquatic walking exercise program

Aquatic walking exercise group 2

12 week land-based walking exercise program

Land-based walking exercise group

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral artery disease (ankle-brachial index between 0.6 and 0.9)
  • years of age
  • Sedentary (less than 1 hour of regular exercise participation per week within the previous year)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Results Point of Contact

Title
Dr. Song-Young Park
Organization
The University of Nebraska at Omaha

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2019

First Posted

February 21, 2019

Study Start

May 9, 2010

Primary Completion

August 8, 2017

Study Completion

February 4, 2019

Last Updated

November 3, 2020

Results First Posted

March 9, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share