NCT05184673

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 8, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 28, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 11, 2022

Completed
Last Updated

July 1, 2022

Status Verified

June 1, 2022

Enrollment Period

5 months

First QC Date

August 26, 2021

Last Update Submit

June 28, 2022

Conditions

Keywords

yogaheart rateexercise

Outcome Measures

Primary Outcomes (5)

  • Continuous heart rate

    Polar Version OH1

    orientation to week 0 (baseline)

  • Continuous heart rate

    Polar Version OH1

    orientation to week 1

  • Continuous heart rate

    Polar Version OH1

    orientation to week 1.5

  • Continuous heart rate

    Polar Version OH1

    orientation to week 2

  • Continuous heart rate

    Polar Version OH1

    orientation to week 2.5

Secondary Outcomes (6)

  • Modified Borg Scale

    orientation to week 1

  • Modified Borg Scale

    orientation to week 1.5

  • Modified Borg Scale

    orientation to week 2

  • Modified Borg Scale

    orientation to week 2.5

  • Yoga Self Efficacy Scale

    Baseline

  • +1 more secondary outcomes

Study Arms (4)

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.

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.

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.

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.

Other: Behavioral and environmental

Interventions

These are all active comparator yoga sequences

flow hotflow thermo-neutralhatha hothatha thermo-neutral

Eligibility Criteria

Age65 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samantha M Harden

Blacksburg, Virginia, 24060, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Environment

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Ecological and Environmental PhenomenaBiological PhenomenaEnvironment and Public Health

Study Officials

  • Samantha M Harden, PhD

    Virginia Polytechnic Institute and State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 26, 2021

First Posted

January 11, 2022

Study Start

June 8, 2021

Primary Completion

October 28, 2021

Study Completion

October 28, 2021

Last Updated

July 1, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations