- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05184673
Moderate Aerobic Activity Through Yoga (MAT)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Virginia
-
Blacksburg, Virginia, United States, 24060
- Samantha M Harden
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: hatha thermo-neutral
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.
|
These are all active comparator yoga sequences
|
Active Comparator: hatha hot
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.
|
These are all active comparator yoga sequences
|
Active Comparator: flow thermo-neutral
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.
|
These are all active comparator yoga sequences
|
Active Comparator: flow hot
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.
|
These are all active comparator yoga sequences
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Continuous heart rate
Time Frame: orientation to week 0 (baseline)
|
Polar Version OH1
|
orientation to week 0 (baseline)
|
Continuous heart rate
Time Frame: orientation to week 1
|
Polar Version OH1
|
orientation to week 1
|
Continuous heart rate
Time Frame: orientation to week 1.5
|
Polar Version OH1
|
orientation to week 1.5
|
Continuous heart rate
Time Frame: orientation to week 2
|
Polar Version OH1
|
orientation to week 2
|
Continuous heart rate
Time Frame: orientation to week 2.5
|
Polar Version OH1
|
orientation to week 2.5
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modified Borg Scale
Time Frame: orientation to week 1
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1
|
Modified Borg Scale
Time Frame: orientation to week 1.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 1.5
|
Modified Borg Scale
Time Frame: orientation to week 2
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2
|
Modified Borg Scale
Time Frame: orientation to week 2.5
|
2-items, 1 (very light activity) -10 (maximal effort)
|
orientation to week 2.5
|
Yoga Self Efficacy Scale
Time Frame: Baseline
|
12-item, 9 point Likert scale, higher score, more self-efficacious
|
Baseline
|
Stanford Leisure-Time Activity Categorical Item
Time Frame: Baseline
|
Score of 1-6, higher is better outcome
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Samantha M Harden, PhD, Virginia Polytechnic Institute and State University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 21-325
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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