Pilot Trial for Adults With Acquired Brain Injury

NCT05793827 | Completed

• 1 other identifier: 1799
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot study will compare a yoga program to a non-yoga exercise program in adults with brain injuries. The investigators will measure possible improvements in balance and heartrate. The investigators also plan to measure changes in brain function and link balance and/or heartrate improvements to changes in brain function. Ideally, this work will create a foundation for a larger-scale study.

Conditions

Acquired Brain Injury; Traumatic Brain Injury; Stroke

Keywords

Yoga; Exercise; Balance; Autonomic Nervous System; Functional Near-Infrared Spectroscopy; Functional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (4)

• Change from Baseline in Standing Balance at 2 Months

  Acquired using a force plate during simultaneous functional near-infrared spectroscopy

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months..

• Change from Baseline in Autonomic Nervous System Function at 2 Months

  Acquired via heart rate variability assessment using electrocardiography

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.

• Change from Baseline in Functional Connectivity of Neural Networks at 2 Months

  Acquired via resting state functional magnetic resonance imaging

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..

• Change from Baseline in Task-Dependent Neural Activation at 2 Months

  Acquired pre- and post-intervention via portable functional near-infrared spectroscopy during standing balance plates with force plate.

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..

Secondary Outcomes (4)

• Change from Baseline in Self-Reported Quality of Life at 2 Months

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session or ~ 2 months..

• Change from Baseline in Working Memory Performance at 2 Months

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months. .

• Change from Baseline in Inhibitory Control at 2 Months

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.

• Change from Baseline in Cognitive Flexibility at 2 Months

  Baseline is 2-3 weeks before yoga or exercise sessions begin; post-intervention is within 2 weeks of the last yoga or exercise session, or ~ 2 months.

Study Arms (2)

Adapted Hatha Yoga

EXPERIMENTAL

Behavioral: Adapted Hatha Yoga

Low-Impact Exercise

ACTIVE COMPARATOR

Behavioral: Low-Impact Exercise

Interventions

Adapted Hatha Yoga BEHAVIORAL

Yoga includes breath work (pranayama), gentle stretching and holding of postures (asanas), and meditation (dhyana). Modifications/adaptations are incorporated so all participants can successfully complete the yoga intervention. Yoga is delivered in a standardized progression, including: focused, slow breath with movement and breathwork throughout every session; mantras, progressively challenging yoga postures (sitting, standing, and floor); and meditation

Adapted Hatha Yoga

Low-Impact Exercise BEHAVIORAL

This includes low-intensity exercise, which is matched to the estimated metabolic costs of yoga, 2.5 Metabolic Equivalent of Task (MET). Sessions include warm up, cool down, and five, 10-minute exercise stations, (e.g., walking, balance, resistance bands, weight-bearing exercise, and core work). Control exercise will be prescribed between 2.0 to 3.0 METs, equating to 30 to 40% heart rate reserve. Heart rate zones are calculated for each participant and monitored to ensure proper intensity

Low-Impact Exercise

Eligibility Criteria

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

You may qualify if:

• Sustained acquired brain injury at least 6 months prior
• Self-reported balance impairment of moderate or greater, via the Neurobehavioral Symptom Inventory
• Standard fMRI safety screening for MRI components only (participants can complete other study components if they are ineligible or unwilling to complete MRI)

You may not qualify if:

• Sustained acquired brain injury within past 6 months
• Self-reported mild balance impairment or no balance impairment

Sponsors & Collaborators

• Colorado State University: lead
• Boettcher Webb-Waring Biomedical Research Awards: collaborator

Study Sites (1)

Translational Medicine Institute

Fort Collins, Colorado, 80524, United States

Location

Related Publications (1)

• Stephens JA, Hernandez-Sarabia JA, Sharp JL, Leach HJ, Bell C, Thomas ML, Buryznska AZ, Weaver JA, Schmid AA. Adaptive yoga versus low-impact exercise for adults with chronic acquired brain injury: a pilot randomized control trial protocol. Front Hum Neurosci. 2023 Nov 23;17:1291094. doi: 10.3389/fnhum.2023.1291094. eCollection 2023.

  PMID: 38077184 DERIVED

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Stroke; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases; Behavior

Study Officials

• Jaclyn Stephens, PhD, OTR

  Colorado State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The principal investigator and postdoctoral fellow are exclusively responsible for assessing outcomes and both are masked to participant group membership. The participants, interventionists, and other key persons are not masked to participant group membership, but they are not involved in any of the outcome assessments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 31, 2023
• Study Start: January 30, 2023
• Primary Completion: November 17, 2023
• Study Completion: November 17, 2023
• Last Updated: June 26, 2024

Record last verified: 2024-06

Locations

US (1)