Strength, Flexibility, And Balance Therapy After Stroke

NCT01109602 | Completed Phase 1 Results

• 1 other identifier: RRP 09-195
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

Approximately 780,000 people suffer a stroke annually in the United States; 200,000 are recurrent strokes. The 17,000 veterans who suffer a stroke yearly are at great risk for a second stroke and therefore should be targeted for stroke risk factor management and prevention interventions. Balance and fear of falling negatively impact activity and function. Decreased activity and blood pressure (BP) are important modifiable stroke risk factors. These can be addressed through a yoga exercise intervention. Yoga, like tai-chi, is old world alternative medicine that has the potential to greatly impact the lives of older adults.

Conditions

Stroke

Keywords

Stroke; accidental falls; Yoga; Blood pressure; Range of Motion; Rehabilitation; Exercise; balance; quality of life; mobility

Outcome Measures

Primary Outcomes (1)

• Balance - Measured With the Berg Balance Scale

  Balance was assessed with the Berg Balance Scale (BBS), a 14-item physical performance measure of static and dynamic balance found to be reliable and valid after stroke. Scoring ranges from 0-56, with higher scores indicating better balance. A score of \<46 identifies an individual at risk for falls after stroke.

  2 months

Secondary Outcomes (2)

• Balance Self-efficacy - Measured With the Activities Balance Confidence Scale

  2 months

• Quality of Life - Measured With the Stroke Specific Quality of Life

  2 months

Study Arms (3)

Arm 1: Yoga Group

EXPERIMENTAL

Yoga Group, 8 week bi-weekly in-person yoga training focused on strength, flexibility, and balance Yoga focused on strength, flexibility, and balance

Other: Yoga focused on strength, flexibility, and balance

Arm 2: Yoga Group Plus

EXPERIMENTAL

Yoga Group Plus: 8 week, bi-weekly in-person yoga training focused on strength, flexibility, and balance paired with almost daily at home yoga focused on breathing and relaxation. Yoga focused on strength, flexibility, and balance Data for both yoga groups were combined for analyses as there were not any differences between these two groups.

Other: Yoga focused on strength, flexibility, and balance

Arm 3: Wait list control group

NO INTERVENTION

wait-list control: will be assessed before and after 8 weeks. Will then be offered the 8 week yoga intervention.

Interventions

Yoga focused on strength, flexibility, and balance OTHER

Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises.

Also known as: HEALTHY after stroke

Arm 1: Yoga Group; Arm 2: Yoga Group Plus

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• veteran
• in the Indianapolis, IN area
• survived a stroke
• on blood pressure medication
• completed all rehabilitation
• ability to stand with or without a device
• able to speak and understand English
• a score \>4 out of 6 on the short mini mental status exam (MMSE)

You may not qualify if:

• would not commit to the yoga intervention
• self report of: serious cardiac conditions; history of serious chronic obstructive pulmonary disease or oxygen dependence; severe weight bearing pain; a history of significant psychiatric illness; uncontrollable diabetes with recent weight loss; and current enrollment in another research trial

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Richard L. Roudebush VA Medical Center

Indianapolis, Indiana, 46202-2884, United States

Location

Related Publications (1)

• Schmid AA, Van Puymbroeck M, Altenburger PA, Schalk NL, Dierks TA, Miller KK, Damush TM, Bravata DM, Williams LS. Poststroke balance improves with yoga: a pilot study. Stroke. 2012 Sep;43(9):2402-7. doi: 10.1161/STROKEAHA.112.658211. Epub 2012 Jul 26.

  PMID: 22836351 RESULT

MeSH Terms

Conditions

Stroke; Motor Activity

Interventions

Pliability

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Mechanical Phenomena; Physical Phenomena

Results Point of Contact

• Title: Arlene Schmid, PhD, OTR
• Organization: Colorado State University, Department of Occupational Therapy

arlene.schmid@colostate.edu

970-491-7562

Study Officials

• Arlene A. Schmid, PhD OTR MS

  Richard Roudebush VA Medical Center, Indianapolis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2010
• First Posted: April 23, 2010
• Study Start: July 1, 2010
• Primary Completion: September 1, 2011
• Study Completion: September 1, 2011
• Last Updated: November 23, 2015
• Results First Posted: November 23, 2015

Record last verified: 2015-11

Locations

US (1)