NCT03544879

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Shorter than P25 for not_applicable

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

January 6, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 2, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2014

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

October 21, 2019

Completed
Last Updated

October 21, 2019

Status Verified

October 1, 2019

Enrollment Period

4 months

First QC Date

May 18, 2018

Results QC Date

August 16, 2019

Last Update Submit

October 17, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • Short Physical Performance Battery (SPPB)

    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.

    Change in SPPB from baseline to 10 weeks

Secondary Outcomes (10)

  • Step Up and Over (SUO)

    Change from baseline to 10 weeks

  • Rhythmic Weight Shift (RWS)

    Change from baseline to 10 weeks

  • Sensory Organization Test (SOT) Vestibular

    Change from baseline to 10 weeks

  • Limits of Stability (LOS)

    Change from baseline to 10 weeks

  • Grip Strength

    Change from baseline to 10 weeks

  • +5 more secondary outcomes

Study Arms (2)

Yoga

EXPERIMENTAL

The yoga intervention consisted of 2x weekly 60-minute sessions for 10 weeks. Yoga consists of postures, breathing exercises, movement, and meditation/concentration..

Behavioral: Yoga Intervention

Health Education

ACTIVE COMPARATOR

The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. Sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion.

Behavioral: Healthy Aging Education

Interventions

The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses.

Yoga

The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. The 90-minute sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion. The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works \& What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed experts (physicians/psychologists, etc) and other clinicians. Instructors were asked not to talk about yoga or medication in their lectures. Content was not otherwise closely monitored.

Health Education

Eligibility Criteria

Age60 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 60-89 years
  • self-reported sedentary lifestyle (not exercising in the past 3 months; included walking at a brisk pace or regular walking for exercise purposes)
  • SPPB summary score \> 3 and ≤ 8
  • willingness attend either yoga or health education for 10 weeks
  • willing to complete two assessments
  • residence in San Diego metropolitan area
  • provided a physician-signed health clearance form.

You may not qualify if:

  • practiced yoga \> 2x in the last year
  • life expectancy \< 12 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Groessl EJ, Maiya M, Schmalzl L, Wing D, Jeste DV. Yoga to prevent mobility limitations in older adults: feasibility of a randomized controlled trial. BMC Geriatr. 2018 Dec 12;18(1):306. doi: 10.1186/s12877-018-0988-8.

MeSH Terms

Conditions

Mobility LimitationSedentary Behavior

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Results Point of Contact

Title
Dr. Erik Groessl
Organization
UC San Diego

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 18, 2018

First Posted

June 4, 2018

Study Start

January 6, 2014

Primary Completion

May 2, 2014

Study Completion

June 30, 2014

Last Updated

October 21, 2019

Results First Posted

October 21, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share

Data is still being analyzed.