The Impact of Yoga-based Physical Therapy for Individuals With Traumatic Brain Injury

NCT03701594 | Completed

• 1 other identifier: Yoga and HRV
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to explore if a yoga-based physical therapy session would promote improved (increased) heart rate variability in subjects with traumatic brain injuries. The results of this pilot study may inform a larger-scale study of the effects of regular participation in a yoga-based program as an adjunct to traditional physical therapy. The secondary objective is to determine whether a yoga-based physical therapy session would impact anxiety, fatigue, or agitation and/or sleep quality. The study will enroll up to 30 inpatient subjects on a rolling basis as they are admitted with traumatic brain injury over a 12 month period at the Shirley Ryan AbilityLab. Each person in the study will participate in three conditions in a random order across three days: 1 hour of yoga-based physical therapy session in a group setting,1 hour of one-on-one conventional physical therapy, and 1 hour of seated rest in a relaxing environment in a group setting. The hypothesis is that individuals who participate in 1 hour of a yoga-based physical therapy session in a group setting will demonstrate a significant improvement in heart rate variability, anxiety, fatigue, and agitation after the session when compared to the same measures after 1 hour of a conventional physical therapy session and 1 hour of seated rest in a relaxing environment. Sleep will also be assessed with an activity monitor.

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (1)

• Heart Rate Variability

  Heart rate variability will be measured by MC-10 sensors placed on the chest.

  The sensors will be worn throughout the three 1 hour long conditions.

Secondary Outcomes (3)

• State-Trait Anxiety - 6 Question Version

  This measure will be administered before and after each condition (yoga, conventional PT, seated rest). Data will be analyzed within approximately 10 months from enrollment of first participant, and research publication will be pursued.

• Global Fatigue Index-Modified

  This measure will be administered before and after each condition (yoga, conventional PT, seated rest). Data will be analyzed within approximately 10 months from enrollment of first participant, and research publication will be pursued.

• Agitated Behavior Scale

  This measure will be administered before and after each condition (yoga, conventional PT, seated rest) only if the person presents with agitation. Data will be analyzed within approximately 10 months from enrollment of first participant.

Study Arms (3)

Yoga-based physical therapy group

EXPERIMENTAL

The yoga-based physical therapy session will take place in an enclosed, quiet space to minimize outside noise or distraction. The lights will be dimmed, and light, instrumental, calming music will be played throughout. The group will consist of approximately 2-5 individuals depending on the physical capabilities and assistance levels required. The session will consist of an introduction to pranayama (foundational breath-based exercises) followed by asanas, or physical postures, that will be modified according to each individual's physical abilities. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery.

Other: Yoga-based physical therapy group

Seated rest

ACTIVE COMPARATOR

Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly.

Other: Seated Rest

Conventional Physical Therapy

ACTIVE COMPARATOR

Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise.

Other: Conventional Physical Therapy

Interventions

Yoga-based physical therapy group OTHER

All yoga-based sessions will be led by the same therapist to maximize between-session consistency. A trained researcher will also be present to provide additional cueing to subjects when required. The basic elements of the postures are similar to that of traditional physical therapy balance exercises. Cues will be provided throughout to pair appropriate breath cycles with appropriate postures consistent with a standard, able-bodied yoga program. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery.

Yoga-based physical therapy group

Seated Rest OTHER

Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly.

Seated rest

Conventional Physical Therapy OTHER

Subjects will engage in 1 hour of a conventional PT session (or "treatment as usual") led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise.

Conventional Physical Therapy

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals diagnosed with traumatic brain injury admitted to the Shirley Ryan AbilityLab (SRALab)
• Age 18 or older
• Able and willing to give written consent or has an identified medical proxy willing to give written consent on behalf of the individual
• Able to follow commands consistently with a reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
• Able to attend to a task with reasonable amount of verbal or visual cues in order to participate in a 60-minute physical therapy session in a group setting
• Behaviorally appropriate for a group setting in terms of verbal or physical escalation/aggression

You may not qualify if:

• Serious cardiac conditions (arrhythmias) or neurological comorbidities (such as multiple sclerosis, Alzheimer's disease, Parkinson's disease, etc.)
• Pregnant or nursing
• Skin allergies or irritation; open wounds in the areas that the sensors would be applied to
• Utilizing a powered, implanted cardiac device for monitoring or supporting heart function (i.e. pacemaker, defibrillator, or LVAD)
• Non-English speaking patients, due to necessity for an interpreter to be present constantly interpreting, which could impact the low-stimulation setting of the intervention
• Aphasia or any difficulties in accurately self-reporting

Sponsors & Collaborators

• Northwestern University: lead
• Shirley Ryan AbilityLab: collaborator

Study Sites (1)

Shirley Ryan AbilityLab

Chicago, Illinois, 60611, United States

Location

Related Publications (1)

• Krese K, Ingraham B, O'Brien MK, Mummidisetty CK, McNulty M, Srdanovic N, Kocherginsky M, Ripley D. The impact of a yoga-based physical therapy group for individuals with traumatic brain injury: results from a pilot study. Brain Inj. 2020 Jul 2;34(8):1118-1126. doi: 10.1080/02699052.2020.1776394. Epub 2020 Jun 12.

  PMID: 32530717 DERIVED

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• David Ripley, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The people administering the self-reported outcome measures will be blinded to the condition the subject participated in.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Brain Injury Medicine and Rehabilitation

Model Details: The study will be a randomized, controlled, single-blinded, crossover design with three conditions: condition A will consist of 1 hour of yoga-based physical therapy session in a group setting; condition B will consist of 1 hour of one-on-one conventional physical therapy; condition C will consist of 1 hour of seated rest in a relaxing environment in a group setting.

Study Record Dates

• First Submitted: October 4, 2018
• First Posted: October 10, 2018
• Study Start: October 22, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

US (1)