Yoga Empowers Seniors Study

Healthy Older Adults Clinical Trial

— YESS  

Official title:

Safe and Effective Yoga Prescription of Seniors: Biomechanical Considerations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01411059
• Other study ID #: 1R01AT004869-01
• Status: Completed
• Phase: N/A
• First received: July 20, 2011
• Last updated: November 14, 2016
• Start date: July 2009
• Est. completion date: April 2011

Study information

• Verified date: November 2016
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

This is an Intervention Development Study (IDS) to quantify the physical demands (using biomechanical investigation) of a 2-phase (beginning & intermediate), 32-week yoga program designed for community-dwelling older adults. Additionally, the IDS will explore the adherence and adverse events of participation in the program. Data from the IDS will be used to develop evidenced-based yoga programs, which the investigators postulate will be associated with fewer musculoskeletal side effects compared to non-evidence based yoga programs. The investigators also postulate that evidenced-based tailoring of yoga for seniors will enhance adherence and efficacy. The programs developed during this IDS will be tested in an expanded, Phase II, Randomized Controlled Trial.

Description:

Yoga is currently being recommended to restore and preserve strength, flexibility, balance, & physical capacity in older adults; however, our clinical trial experiences suggest that without proper evidenced-based prescription, Yoga participation can be ineffective or even injurious for seniors. To address this lack of evidence-based knowledge, the proposed IDS will: 1) quantify the physical demands of a 32-wk Yoga program designed for independent ambulatory seniors; 2) characterize the relations between these demands and participant physical characteristics; 3) examine the adherence, efficacy, & safety of the program; and 4) characterize the relations among reported adverse events, baseline participant characteristics, and Yoga physical demands.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Community dwelling men and women volunteers, aged 65 years or older.

Exclusion Criteria:

• Safety exclusions:

--the following safety exclusions are adopted in order to decrease potential *cardiovascular

• musculoskeletal

• neurological risks to the participants:

• active angina

• uncontrolled hypertension (SBP greater than 160 or DBP greater than 90)

• high resting pulse or respiratory rate (HR >90 or RR>24 after 5 minutes seated)

• unstable asthma or exacerbated COPD

• cervical spine instability or other significant neck injury

• rheumatoid arthritis

• unstable ankle, knee, hip, shoulder, elbow, or wrist joints

• hemiparesis or paraparesis

• movement disorders (e.g. Parkinson's disease), peripheral neuropathies, stroke with residual deficits, severe vision or hearing problems

• walker or wheelchair use

• insufficient hearing to permit safety in a yoga group setting

• not able to attend in-person classes

• has not had check-up by regular provider within 12 months (if not taking any prescription medications) or in the past 6 months (if any regular medicines taken); cannot pass specific movement safety tests (tests described in section on screening visits, below)

• Feasibility/adherence exclusions:

1. unable to understand their commitment to the project, (laboratory visits & regular program participation)

2. cognitive limitations significant enough to preclude informed consent or to raise concerns about participation safety

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Older Adults

Intervention

Behavioral:
• yoga
yoga classes 2 times per week for 32 weeks

Locations

Country	Name	City	State
United States	UCLA	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak joint moments	These are the torques produced by the muscles during performance of the yoga poses	difference from baseline to 16 wk	Yes
Primary	peak joint moments	These are the torques produced by the muscles during performance of the yoga poses	difference from 16 wk to 32 wk	Yes
Secondary	time to stand and sit from a chair 5 times	In the 5-Repetition Chair Stand Test, we record the time it takes for a participant to repeatedly stand and sit on a chair 5 times.	baseline, 16 and 32 weeks	No
Secondary	number of heel-rise repetitions	The Heel-Rise Test is a measure of plantar-flexion endurance. Here, we record the number of full range-of-motion, heel-rise repetitions the participants can complete before fatigue.	baseline, 16 and 32 weeks	No
Secondary	Time to complete Up & Go test	In the Up & Go Test, a measure of mobility, we record the number of seconds it takes to rise from a chair, walk 8 feet, return and sit in the chair.	baseline, 16 and 32 weeks	No
Secondary	Number of marching steps completed within 2 minutes	In the 2-Minute Step Test, a measure stepping endurance, we record the number of complete marching steps the participant can perform within a 2-minute period	baseline, 16 and 32 weeks	No
Secondary	Distance participant can reach forward from a sitting position	The sit and reach test measures overall sagittal-plane flexibility. The participant is asked to reach as far as possible toward their dominant limb while remaining seated.	baseline, 16 and 32 weeks	No
Secondary	Distance between fingers of opposing hands as participant attempts to touch fingers while reaching posteriorly.	The Back Scratch Test measures upper extremity flexibility. Here the distance between finger-tips is recorded as the participant reaches posteriorly and attempts to touch opposing hands.	baseline, 16 and 32 weeks	No
Secondary	Maximum passive wrist flexion, extension, radial-deviation, and ulnar-deviation, range of motion (in degrees).	These tests measure the range of motion of the wrist in the sagittal and frontal planes.	baseline, 16 and 32 weeks	No
Secondary	Maximum height participant can reach while standing	Here we quantify the maximum vertical height participants can reach while standing.	baseline, 16 and 32 weeks	No
Secondary	Maximum distance participant can reach forward while standing	THe Maximum Forward Reach test is a measure of strength and flexibility. Here we record the maximum distance the participant can reach forward while standing.	baseline, 16 and 32 weeks	No
Secondary	stride length during walking	Here we quantify the stride length of participants during walking at a self-selected pace.	baseline, 16 and 32 weeks	No
Secondary	Maximum joint angle	Here we quantify the maximum joint angles of the ankle, knee, hip, trunk, shoulder, elbow, and wrist during performance of the yoga poses.	baseline, 16 and 32 weeks	Yes
Secondary	Sway distance of the center of pressure	Here we quantify the movement of the center of pressure as participants stand as still as possible	baseline, 16 and 32 weeks	No
Secondary	Electromyographic activity of muscles	Here we record the electromyographic activity of the Anterior Deltoid, Triceps surae, Obliques, Rectus Abdominus, Erector Spinae, Gluteus Maximus, Lateral Hamstrings, Vastus Lateralis, Gastrocnemius, and Gluteus Medius, muscles during performance of the yoga poses.	baseline, 16 and 32 weeks	No
Secondary	SF-36 score	Health related quality of life and mood will be assessed with the RAND Short Form-36 (Hays, 1993). The SF-36 includes sub-scales that measure: 1) health-related limitations in physical function; 2) health-related limitations in role and in social function; 3) emotional function (including positive and negative mood states); 4) pain.	baseline and 36 weeks	No