Peripheral Artery DiseaseNCT03849300
Impacts of Aquatic vs Land Walking on Vascular Health and Exercise Tolerance in Patients With Peripheral Artery Disease
A study testing Aquatic walking exercise program group 1, Aquatic walking exercise program group 2 and Land-based walking exercise group in people with Peripheral Artery Disease and Vascular Function, run by Pusan National University.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Vascular Function, Exercise Tolerance
- What is being tested?
- Aquatic walking exercise program group 1, Aquatic walking exercise program group 2 and Land-based walking exercise group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- No sites listed yet
- Study dates
- 9 May 2010to 4 Feb 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- current smoker (smoking within previous 6 months)
- psychiatric conditions
- pulmonary disease
- renal disease
- thyroid disease
About this study
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
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.
- Conditions
- Peripheral Artery Disease, Vascular Function, Exercise Tolerance, Peripheral Arterial Disease
- Being tested
- Aquatic walking exercise program group 1, Aquatic walking exercise program group 2, Land-based walking exercise group
- Keywords
- arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic walking exercise program group 1Other
12 week aquatic walking exercise program
Aquatic walking exercise program group 2Other
12 week aquatic walking exercise program
Land-based walking exercise groupOther
12 week land-based walking exercise program
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Other: Land-based walking exercise group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (13)
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start9 May 2010
- Primary completion8 Aug 2017
- Study completion4 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pusan National University
- Sponsor type
- University, hospital or other
- Collaborators
- Marymount University, Dong-Eui University
- Responsible party
- Principal investigator, Won-mok son, Pusan National University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849300
- Sponsor's protocol ID
- UNOmaha5
- Status last verified
- Oct 2020
- First submitted
- 19 Feb 2019
- Last updated
- 3 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03849300
- Acronym / sponsor ID
- UNOmaha5
- Conditions
- Peripheral Artery Disease, Vascular Function, Exercise Tolerance, Peripheral Arterial Disease
- Keywords
- arterial stiffness, cardiorespiratory capacity, exercise tolerance, VO2max
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- Pusan National UniversityUniversity, hospital or other
- Collaborators
- Marymount University, Dong-Eui University
- Study start
- 9 May 2010 (actual)
- Primary completion
- 8 Aug 2017 (actual)
- Study completion
- 4 Feb 2019 (actual)
- First posted
- 21 Feb 2019 (actual)
- Results
- Posted 9 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- aquatic walking exercise intervention group 1 vs. control group; aquatic walking exercise intervention group 2 vs. land-based walking exercise group
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –No exercise intervention |
| Aquatic walking exercise group 1 | Experimental | Other: Aquatic walking exercise program group 1The 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. |
| Aquatic walking exercise group 2 | Experimental | Other: Aquatic walking exercise program group 2The 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. |
| Land-based walking exercise group | Active comparator | Other: Land-based walking exercise groupThe 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (5 listed)
- current smoker (smoking within previous 6 months)
- psychiatric conditions
- pulmonary disease
- renal disease
- thyroid disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic walking exercise program group 112 week aquatic walking exercise program | Other | Aquatic walking exercise group 1 |
| Aquatic walking exercise program group 212 week aquatic walking exercise program | Other | Aquatic walking exercise group 2 |
| Land-based walking exercise group12 week land-based walking exercise program | Other | Land-based walking exercise group |
Primary outcome
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.
13 secondary outcomes
Body Composition
Time frame: 12 weeks
Resting Heart Rate
Time frame: 12 weeks
Systolic Blood Pressure
Time frame: 12 weeks
Resting Metabolic Rate
Time frame: 12 weeks
Cardiorespiratory Capacity
Time frame: 12 weeks
Exercise Tolerance - Walking Capacity
Time frame: 12 weeks
Upper Body Strength
Time frame: 12 weeks
Lower Body Strength
Time frame: 12 weeks
Lower Body Flexibility
Time frame: 12 weeks
Medical Outcomes Study Short-Form 36 General Health Survey for Physical Function
Time frame: 12 weeks
Diastolic Blood Pressure
Time frame: 12 weeks
Systemic Arterial Stiffness
Time frame: 12 weeks
Time to Onset of Claudication
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Peripheral Artery Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic walking exercise program group 1, Aquatic walking exercise program group 2 and Land-based walking exercise group in people with Peripheral Artery Disease and Vascular Function, run by Pusan National University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Arterial Stiffness (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2020; AzTrials last refreshed its copy on 8 Nov 2026.