NCT03544879

Yoga to Prevent Mobility Limitations in Older Adults

Completed NA Results posted Last updated 21 October 2019

What this trial tests

NA trial testing Yoga Intervention in Aging in 46 participants. Completed in 30 June 2014.

Timeline

6 January 2014

Primary endpoint
2 May 2014

30 June 2014

Quick facts

Lead sponsor	University of California, San Diego
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	46
Start date	6 January 2014
Primary completion	2 May 2014
Estimated completion	30 June 2014

Drugs / interventions tested

• Yoga Intervention
• Healthy Aging Education

Conditions studied

• Aging — all drugs for Aging →
• Mobility Limitation — all drugs for Mobility Limitation →
• Sedentary Lifestyle — all drugs for Sedentary Lifestyle →

Sponsor

University of California, San Diego

Who can join

Adults 60 to 89, any sex, with Aging or Mobility Limitation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Short Physical Performance Battery (SPPB) Primary · Change in SPPB from baseline to 10 weeks

The Short Physical Performance Battery (SPPB) measures time to walk four meters; time to five chair stands; and balance, with higher scores being associated with decreased disability and mortality. These 3 components are rated on a scale from 0-4 and they are summed to provide a total SPPB score ranging from 0-12.

Group	Value	95% CI
Yoga	1.55	± 1.67
Health Education	1.18	± 1.33

Step Up and Over (SUO) Secondary · Change from baseline to 10 weeks

The Step Up and Over (SUO) test measures gait quality as it may influence negotiating curbs, climbing or descending stairs, and predicting fall risk. The lift index quantifies the maximum lifting force exerted by the leading leg expressed as a percentage of the individual's weight as measured by the force plate, with scores closer to 100% demonstrating greater force.

Group	Value	95% CI
Health Education	-0.65	± 9.0
Yoga	8.7	± 26.3

Rhythmic Weight Shift (RWS) Secondary · Change from baseline to 10 weeks

Rhythmic Weight Shift (RWS) measures participant ability to rhythmically move between two targets at different speeds. The On-Axis Velocity is the speed of the COG displacement in degrees per second during on-axis movement between the test target(s), with greater velocity indicating faster movement through the region of stability

Group	Value	95% CI
Health Education	0.07	± 1.14
Yoga	-0.15	± 0.83

Sensory Organization Test (SOT) Vestibular Secondary · Change from baseline to 10 weeks

The SOT assesses the sensory components of balance by measuring postural sway balance in different conditions as a useful predictor of fall risk. The ratio score indicates ability to maintain balance in the presence of inaccurate visual cues. Scores are represented as a percentage from 0 to 100, with scores closer to 100 indicating greater stability.

Group	Value	95% CI
Health Education	-1.1	± 23.8
Yoga	8.9	± 29.1

Limits of Stability (LOS) Secondary · Change from baseline to 10 weeks

The LOS is used to define a participant's "cone of stability" and measures components of balance and stability related to reaction time, directional control, and the ability to make corrective movements. Movement velocity indicates the speed of center of gravity (COG) displacement in degrees per second, with higher values signifying quicker movement through the region of stability.

Group	Value	95% CI
Health Education	-0.62	± 1.62
Yoga	0.51	± 1.61

Grip Strength Secondary · Change from baseline to 10 weeks

Grip Strength was assessed with an adjustable, hydraulic grip strength dynamometer.(26) The measure uses the average of two trials for both the left and right hand.

Group	Value	95% CI
Yoga	0.12	± 8.03
Health Education	-5.2	± 11.72

SF-36 Secondary · Change from baseline to 10 weeks

The SF-36 has 36 items and takes about 8-10 minutes to complete. The scale measure domains of health-related quality of life and two summary scores corresponding to physical and mental health. Scores for each subscale are standardized and range from 0-100 with higher scores representing better quality of life.

Physical

Group	Value	95% CI
Yoga	0.23	± 5.99
Health Education	-1.2	± 5.21

Mental

Group	Value	95% CI
Yoga	0.7	± 5.6
Health Education	-3.2	± 7.7

Center for Epidemiologic Studies Short Depression Scale (CES-D 10) Secondary · Change from baseline to 10 weeks

Depression was assessed using the 10-item Center for Epidemiologic Studies Short Depression Scale (CES-D 10). Scores can range from 0-30 with higher scores indicating higher levels of depressive symptoms.

Group	Value	95% CI
Yoga	-0.35	± 3.15
Health Education	1.14	± 3.59

Brief Anxiety Inventory (BAI) Secondary · Change from baseline to 10 weeks

Anxiety was assessed using the Brief Anxiety Inventory (BAI). The self-administered BAI consists of 21 items, and has well-established reliability(29) and validity. Scores can range from 0-63 with higher scores indicating greater levels of anxiety.

Group	Value	95% CI
Yoga	0.18	± 7.48
Health Education	2.87	± 5.89

Pittsburgh Sleep Quality Index (PSQI) Secondary · Change from baseline to 10 weeks

Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). The measure has 21 items and scores can range from 0-21 with higher scores indicating lower sleep quality.

Group	Value	95% CI
Yoga	-0.5	± 2.52
Health Education	-0.2	± 2.27

Participant Satisfaction Secondary · 10 weeks

Participant Satisfaction with participation was rated on a 0-10 scale (10 = most positive) usingquestions about enjoyment with and benefits of participation.

Group	Value	95% CI
Health Education	8.1	± 2.7
Yoga	8.4	± 2.8

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Yoga

Serious: 0/22 (0%)

Deaths: 0/22

Health Education

Serious: 0/24 (0%)

Deaths: 0/24

Other adverse events (1 terms — click to expand)

Reaction	System	Yoga	Health Education
Increased pain	Musculoskeletal and connective tissue disorders	—	—

Data from ClinicalTrials.gov NCT03544879 adverse events section.

Sponsor's own description

The loss of mobility during aging impacts independence and leads to further disability, morbidity, and reduced life expectancy. The study objective was to examine the feasibility and safety of conducting a randomized controlled trial of yoga for older adults at risk for mobility limitations. The investigators hypothesized that sedentary older adults could be recruited for the study, would attend either yoga or a health education control, would complete assessments, and that the interventions could be safely delivered.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial.
   Groessl EJ, Maiya M, Schmalzl L, Wing D, et al · · 2018 · cited 20× · PMID 30541474 · DOI 10.1186/s12877-018-0988-8