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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05184673
Other study ID # 21-325
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 8, 2021
Est. completion date October 28, 2021

Study information

Verified date June 2022
Source Virginia Polytechnic Institute and State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date October 28, 2021
Est. primary completion date October 28, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 65 Years to 85 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Behavioral and environmental
These are all active comparator yoga sequences

Locations

Country Name City State
United States Samantha M Harden Blacksburg Virginia

Sponsors (1)

Lead Sponsor Collaborator
Virginia Polytechnic Institute and State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Continuous heart rate Polar Version OH1 orientation to week 0 (baseline)
Primary Continuous heart rate Polar Version OH1 orientation to week 1
Primary Continuous heart rate Polar Version OH1 orientation to week 1.5
Primary Continuous heart rate Polar Version OH1 orientation to week 2
Primary Continuous heart rate Polar Version OH1 orientation to week 2.5
Secondary Modified Borg Scale 2-items, 1 (very light activity) -10 (maximal effort) orientation to week 1
Secondary Modified Borg Scale 2-items, 1 (very light activity) -10 (maximal effort) orientation to week 1.5
Secondary Modified Borg Scale 2-items, 1 (very light activity) -10 (maximal effort) orientation to week 2
Secondary Modified Borg Scale 2-items, 1 (very light activity) -10 (maximal effort) orientation to week 2.5
Secondary Yoga Self Efficacy Scale 12-item, 9 point Likert scale, higher score, more self-efficacious Baseline
Secondary Stanford Leisure-Time Activity Categorical Item Score of 1-6, higher is better outcome Baseline
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