Physical PerformanceNCT05573087
Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults
A study testing Aquatic Based Exercise and Land Based Exercise in people with Physical Performance, run by West Virginia University at 1 site in United States.
Trial summary
Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Physical Performance
- What is being tested?
- Aquatic Based Exercise and Land Based Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- English speaking
- sedentary individuals; Sedentary will be defined as less than 150 minutes of exercise/week as defined by the CDC and American College of Sports Medicine
- All subjects will be screened with a resting 12 lead EKG to ensure they are safe to exercise
Who cannot join
- Any vulnerable populations will be excluded including adults unable to consent/Cognitively Impaired
- individuals who are not yet adults
- pregnant or nursing women
- prisoners or other detained individuals
Trial locations and contacts
1 site in 1 country.
United States1 site
West Virginia University
Morgantown, West Virginia, 26506
About this study
Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. However, to date, no study has yet examined whether aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this study is to determine whether there are significant differences in clinical and performance outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity Interval Training (REHIIT) protocol.
- Conditions
- Physical Performance
- Being tested
- Aquatic Based Exercise, Land Based Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic Based ExerciseOther
10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks
Land Based ExerciseOther
10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks
| Study group | Role | What they receive |
|---|---|---|
| Aquatic Based Exercise | Active comparator | maximal jump squats in a pool Receives: Other: Aquatic Based Exercise |
| Land Based Exercise | Active comparator | cycle ergometer Receives: Other: Land Based Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiorespiratory Fitness
Percent changes in VO2 is milliliters of oxygen per kilogram of body weight per minute (oxygen in milliliters, weight in kilograms, and time in minutes and expressed in ml/kg/min).
Measured: Baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start19 Jan 2021
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physical PerformanceStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miriam Leary, West Virginia University
- Investigators
- Miriam Leary, PhD, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05573087
- Sponsor's protocol ID
- 1911776700
- Status last verified
- Oct 2022
- First submitted
- 5 Oct 2022
- Last updated
- 10 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Land-based and Aquatic Reduced Exertion High Intensity Interval Training in Sedentary Young Adults
- ClinicalTrials.gov ID
- NCT05573087
- Acronym / sponsor ID
- 1911776700
- Conditions
- Physical Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- 19 Jan 2021 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous research has found improvements in performance (VO2max) and clinical (insulin resistance) with cycling REHIIT. In some populations (e.g. obese, arthritic) aquatic exercise is a safer, more enjoyable option. However, to date, no study has yet examined whether aquatic REHIIT confers the same benefits as land-based REHIIT. Therefore, the purpose of this study is to determine whether there are significant differences in clinical and performance outcomes between a land-based and comparable aquatics based Reduced Exertion High Intensity Interval Training (REHIIT) protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic Based Exercise | Active comparator | Other: Aquatic Based Exercisemaximal jump squats in a pool |
| Land Based Exercise | Active comparator | Other: Land Based Exercisecycle ergometer |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- English speaking
- sedentary individuals; Sedentary will be defined as less than 150 minutes of exercise/week as defined by the CDC and American College of Sports Medicine
- All subjects will be screened with a resting 12 lead EKG to ensure they are safe to exercise
Key exclusion criteria (4 listed)
- Any vulnerable populations will be excluded including adults unable to consent/Cognitively Impaired
- individuals who are not yet adults
- pregnant or nursing women
- prisoners or other detained individuals
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 Based Exercise10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks | Other | Aquatic Based Exercise |
| Land Based Exercise10 minutes of exercise with two 20 second sprints three days per week for 8 consecutive weeks | Other | Land Based Exercise |
Primary outcome
Changes in Cardiorespiratory Fitness
Time frame: Baseline to 8 weeks
Percent changes in VO2 is milliliters of oxygen per kilogram of body weight per minute (oxygen in milliliters, weight in kilograms, and time in minutes and expressed in ml/kg/min).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2022.
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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.
Miriam Leary, PhD principal investigator
West Virginia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic Based Exercise and Land Based Exercise in people with Physical Performance, run by West Virginia University at 1 site in United States.
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 4 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in Cardiorespiratory Fitness (time frame: Baseline to 8 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 10 Oct 2022.