Physical ActivityMATNCT05184673

Moderate Aerobic Activity Through Yoga

A study testing Behavioral and environmental in people with Physical Activity, run by Virginia Polytechnic Institute and State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 65 to 85 yearsHealthy volunteers can take part
Conditions the study is for: Physical Activity
What is being tested?: Behavioral and environmental
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2021to 28 Oct 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 65 to 85 years
All sexes
Healthy volunteers accepted
Older adult

Who may be able to join

Assessed as physical activity readiness i. For those 65-70 years of age. We will also use the Physical Readiness Questionnaire Plus-this "plus" version was developed to be more inclusive of those with limited mobility and not to over-exclude older adults in other clinical trials. If a participant fails the Physical Activity Readiness Questionnaire + (PARQ+), a physician's approval will be mandatory ii. For those 70-85 years of age. Complete PARQ+ as well as physician approval.
Comprehension of English language
Able to physically attend class at the yoga studio

Who cannot join

Contraindication to physical activity including but not limited to people who can independently walk and stand. This will be part of the verbal screening protocol using Falls Efficacy Scale (FES). This scale has a minimum of 16 (no concern about falling) to maximum of 64 (severe concern about falling). Participants with FES score > 23 will be deemed high concern about falling and be excluded from participation.
Assesses the presence and severity of 13 psychiatric symptom domains that cut across diagnostic boundaries. These domains include depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts and behaviors, suicidal thoughts and behaviors, substance use (e.g., alcohol, nicotine, prescription medication, and illicit substance use), personality functioning, dissociation, and cognition/memory problems in adults. Level 1 of this measure includes 23 questions across the 13 domains.

Trial locations and contacts

1 site in 1 country.

United States1 site

Samantha M Harden
Blacksburg, Virginia, 24060

Other trials in United States

About this study

The 2018 Physical Activity Guidelines for Americans (PAGA) recommend 150 minutes of moderate intensity activity for adult (18 years and older) Americans to promote health. PAGA also recommends that older adults (65+) engage in multicomponent and balance exercises weekly as a way to reduce falls and injuries from falls. This recommendation includes yoga, however, the current research and recommendations on using yoga to meet moderate intensity activity guidelines is limited. This study will utilize heart rate monitoring to determine if certain styles of yoga can be used to meet the PAGA.

Read the detailed description

The 2018 Physical Activity Guidelines for Americans recommend 150 minutes of moderate intensity physical activity each week to promote health. The most recent scientific advisory committee had insufficient evidence to provide recommendations on how the physical practice of yoga fits into the physical activity guidelines. Currently, there have been few studies done on yoga and its relative intensity. Previous randomized, cross-over trial to determine the effects of room temperature (hot yoga versus thermo-neutral environment) on subjective and objective markers of exercise intensity. They concluded that using objective markers (%VO2max) both thermo-neutral and hot yoga would be considered light intensity activity. Previous investigation of power yoga, heart rate, skin temperature, and body mass to determine that power yoga could be considered a moderate-vigorous intensity activity.

Currently, there is a gap in the research on understanding the intensity of exercise offered within a typical yoga studio including "flow", hatha/classical, and hot yoga. Most yoga classes are about 60 minutes in length, and yoga classes of that length have not been investigated. There is also minimal research done on whether wearable activity trackers and accelerometers are able to accurately assess heart rate, and therefore activity intensity level in a yoga setting.

Conditions: Physical Activity
Being tested: Behavioral and environmental
Keywords: yoga, heart rate, exercise
Medical subject headings: Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Behavioral and environmentalOther
These are all active comparator yoga sequences

Study groups in NCT05184673
Study group	Role	What they receive
hatha thermo-neutral	Active comparator	The hatha classes will hold each pose for 5 breaths in a room temperature (~70 degrees Fahrenheit) space. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2. Receives: Other: Behavioral and environmental
hatha hot	Active comparator	The hatha hot classes will hold each pose for 5 breaths in a room heated to 95 degrees Fahrenheit. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2. Receives: Other: Behavioral and environmental
flow thermo-neutral	Active comparator	The flow hot classes will flow from each pose (one breath per movement) a room temperature (~70 degrees Fahrenheit) space. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2. Receives: Other: Behavioral and environmental
flow hot	Active comparator	The flow hot classes will flow from each pose (one breath per movement) in a room heated to 95 degrees Fahrenheit. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2. Receives: Other: Behavioral and environmental

What is being measured

The primary outcome is the main question the study is designed to answer.

Continuous heart rate
Polar Version OH1
Measured: orientation to week 0 (baseline)
Continuous heart rate
Polar Version OH1
Measured: orientation to week 1
Continuous heart rate
Polar Version OH1
Measured: orientation to week 1.5
Continuous heart rate
Polar Version OH1
Measured: orientation to week 2
Continuous heart rate
Polar Version OH1
Measured: orientation to week 2.5

Secondary outcomes (6)

Modified Borg Scale
2-items, 1 (very light activity) -10 (maximal effort)
Measured: orientation to week 1
Modified Borg Scale
2-items, 1 (very light activity) -10 (maximal effort)
Measured: orientation to week 1.5
Modified Borg Scale
2-items, 1 (very light activity) -10 (maximal effort)
Measured: orientation to week 2
Modified Borg Scale
2-items, 1 (very light activity) -10 (maximal effort)
Measured: orientation to week 2.5
Yoga Self Efficacy Scale
12-item, 9 point Likert scale, higher score, more self-efficacious
Measured: Baseline
Stanford Leisure-Time Activity Categorical Item
Score of 1-6, higher is better outcome
Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 202128 Oct 2021

First posted11 Jan 2022
Study start8 Jun 2021
Primary completion28 Oct 2021
Study completion28 Oct 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Physical ActivityStudies 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: Each group of participants will complete four different yoga classes - hatha thermo-neutral, flow thermo-neutral, hatha hot, and flow hot - in different orders, keeping the time of the class, the other participants in the class, the instructor, and the sequence of the moves the same.
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05184673
Sponsor's protocol ID: 21-325
Acronym: MAT
Status last verified: Jun 2022
First submitted: 26 Aug 2021
Last updated: 1 Jul 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
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Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
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A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
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Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
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All Physical Activity trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Moderate Aerobic Activity Through Yoga
ClinicalTrials.gov ID: NCT05184673
Acronym / sponsor ID: MAT / 21-325
Conditions: Physical Activity
Keywords: yoga, heart rate, exercise
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: Virginia Polytechnic Institute and State UniversityUniversity, hospital or other
Study start: 8 Jun 2021 (actual)
Primary completion: 28 Oct 2021 (actual)
Study completion: 28 Oct 2021 (actual)
First posted: 11 Jan 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.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4
Model description: Each group of participants will complete four different yoga classes - hatha thermo-neutral, flow thermo-neutral, hatha hot, and flow hot - in different orders, keeping the time of the class, the other participants in the class, the instructor, and the sequence of the moves the same.

Arm	Type	Receives
hatha thermo-neutral	Active comparator	Other: Behavioral and environmentalThe hatha classes will hold each pose for 5 breaths in a room temperature (~70 degrees Fahrenheit) space. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
hatha hot	Active comparator	Other: Behavioral and environmentalThe hatha hot classes will hold each pose for 5 breaths in a room heated to 95 degrees Fahrenheit. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
flow thermo-neutral	Active comparator	Other: Behavioral and environmentalThe flow hot classes will flow from each pose (one breath per movement) a room temperature (~70 degrees Fahrenheit) space. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.
flow hot	Active comparator	Other: Behavioral and environmentalThe flow hot classes will flow from each pose (one breath per movement) in a room heated to 95 degrees Fahrenheit. Yoga sessions will be led by a 500hr Registered Yoga Teacher. This reduces the risk for injury due to the extensive training the yoga teacher will have received and the knowledge of cuing and sequencing for best practice. All study personnel will be vaccinated against SARS-CoV-2, reducing the risk of spreading SARS-CoV-2.

Who may qualify

Ages: 65 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Assessed as physical activity readiness i. For those 65-70 years of age. We will also use the Physical Readiness Questionnaire Plus-this "plus" version was developed to be more inclusive of those with limited mobility and not to over-exclude older adults in other clinical trials. If a participant fails the Physical Activity Readiness Questionnaire + (PARQ+), a physician's approval will be mandatory ii. For those 70-85 years of age. Complete PARQ+ as well as physician approval.
Comprehension of English language
Able to physically attend class at the yoga studio

Key exclusion criteria (2 listed)

Contraindication to physical activity including but not limited to people who can independently walk and stand. This will be part of the verbal screening protocol using Falls Efficacy Scale (FES). This scale has a minimum of 16 (no concern about falling) to maximum of 64 (severe concern about falling). Participants with FES score > 23 will be deemed high concern about falling and be excluded from participation.
Assesses the presence and severity of 13 psychiatric symptom domains that cut across diagnostic boundaries. These domains include depression, anger, mania, anxiety, somatic symptoms, sleep disturbance, psychosis, obsessive thoughts and behaviors, suicidal thoughts and behaviors, substance use (e.g., alcohol, nicotine, prescription medication, and illicit substance use), personality functioning, dissociation, and cognition/memory problems in adults. Level 1 of this measure includes 23 questions across the 13 domains.

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
Behavioral and environmentalThese are all active comparator yoga sequences	Other	flow hot, flow thermo-neutral, hatha hot, hatha thermo-neutral

Primary outcome

Continuous heart rate
Time frame: orientation to week 0 (baseline)
Polar Version OH1
Continuous heart rate
Time frame: orientation to week 1
Polar Version OH1
Continuous heart rate
Time frame: orientation to week 1.5
Polar Version OH1
Continuous heart rate
Time frame: orientation to week 2
Polar Version OH1
Continuous heart rate
Time frame: orientation to week 2.5
Polar Version OH1

6 secondary outcomes

Modified Borg Scale
Time frame: orientation to week 1
Modified Borg Scale
Time frame: orientation to week 1.5
Modified Borg Scale
Time frame: orientation to week 2
Modified Borg Scale
Time frame: orientation to week 2.5
Yoga Self Efficacy Scale
Time frame: Baseline
Stanford Leisure-Time Activity Categorical Item
Time frame: Baseline

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 1 Jul 2022.
Individual participant dataSharing planned: No

Related trials for Physical Activity

Active, not recruiting
Comparison of the Effects of Kinesio Taping and Interval Exercise in Patients Diagnosed With Venous Insufficiency: A Randomised Controlled Trial
Chronic Venous Insufficiency C2 and Below
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Not yet recruitingPhase 1/2
A Study of SRN-101 Gene Therapy in Adults With Recurrent High-Grade Glioma (ALERT-1)
Recurrent High Grade Gliomas, Glioblastoma (GBM)
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B

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.

Samantha M Harden, PhD principal investigator

Virginia Polytechnic Institute and State 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 Behavioral and environmental in people with Physical Activity, run by Virginia Polytechnic Institute and State 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 2 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 1 Jul 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?

Continuous heart rate (time frame: orientation to week 0 (baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05184673.

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 1 Jul 2022.