RHBS Brain and Balance Study of Older Adults

NCT04796870 | Completed

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

Brief Summary

Brief Summary: Cognition and balance are known to decline during the aging process. Cognitive performance is essential for functional independence and determines whether an individual can perform instrumental daily living activities (e.g., finances, driving, independent living). Balance is critical for participation in everyday life activities. Impaired balance increases fall risk, and subsequent injury increased caregiver dependency and decreased independence. The purpose of this study is to investigate the outcomes of 24 sessions of online mobility and cognitive training (35 minutes/session, 3x/week, 8-12 weeks) for community-based older adults. The exercise program is progressively challenging and emphasizes balance, cardiovascular conditioning, attention, and working memory. The primary outcomes of interest are cognitive performance and balance changes, with secondary outcomes relating to self-efficacy, resilience, and physical activity.

Conditions

Cognitive Performance; Balance

Keywords

Attention; Working Memory; Visual Spatial Memory

Outcome Measures

Primary Outcomes (4)

• Change in Attention and Auditory Working Memory

  (A) as measured by the Digit Span subset of Wechsler Adult Intelligence Scale- 4th Edition (WAIS-IV); Each correct response is worth 1 point, with a maximum of 14 for each sub-score and for a total score of 24. Higher scores are indicative of better outcome. (B) as measured by Letter-Number Sequencing, each correct response is worth 1 point, with a maximum total score of 21. Higher scores are indicative of better outcome.

  pre and post 8-week intervention protocol

• Change in Visual Spatial Working Memory

  as measured by the Spatial Addition Subset of Wechsler Memory Scale- 4th Edition (WMS-IV); This is a 24-item assessment, each correct response is worth 1 point for a total score of 24. Higher scores are indicative of better outcome.

  pre and post 8-week intervention protocol

• Change in Information Processing Speed

  as measured by the Simple and Choice Reaction Times

  pre and post 8-week intervention protocol

• Change in Static Balance in a Standing Position

  as measured by the Four-Stage Balance Test

  pre and post 8-week intervention protocol

Secondary Outcomes (6)

• Change in Resilience

  pre and post 8-week intervention protocol

• Change in Confidence in Performing Various Activities

  pre and post 8-week intervention protocol

• Change in Level of Physical Activity

  pre and post 8-week intervention protocol

• Change in Leg Strength

  pre and post 8-week intervention protocol

• Change in Lower Extremity Kinematic parameters

  pre and post 8-week intervention protocol

Study Arms (1)

Experimental: Online Brain and Balance Training

EXPERIMENTAL

Individuals that meet the inclusion/exclusion criteria and enrolled in the study will participate in a 8-week virtual balance and cognitive training intervention performed three times a week.

Other: Online Brain and Balance Training Program

Interventions

Online Brain and Balance Training Program OTHER

The intent of the intervention is to encompass cardiovascular conditioning, cognitive performance and balance performance improvements. To promote cardiovascular conditioning the exercises are structured to keep the participant in motion while maintaining an elevated heart rate using techniques such as squats, marching and upper extremity movements. The video provides adaptations to increase or decrease the challenge based on subject ability. To promote cognitive performance, participants will be asked to complete simple and complex cognitive tasks, such as arithmetic, spatial memory recall and attention while completing the physical exercises. To promote balance performance, the videos include single limb stance and weight shifting tasks. Videos are presented in a progressively challenging manner for all domains.

Experimental: Online Brain and Balance Training

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• Ability to take at least 4 steps without an assistive device
• Ability to speak English

You may not qualify if:

• Inability to ambulate at least 4 steps without assistive device
• Uncontrolled cardiovascular, pulmonary, neurological, or metabolic disease which may impact the ability to exercise or in which exercise is contraindicated
• Cognitive or psychiatric impairment precluding informed consent or ability to following instructions

Sponsors & Collaborators

• George Mason University: lead

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

Study Officials

• Andrew A Guccione, PT, PhD, DPT

  George Mason University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 15, 2021
• Study Start: April 28, 2021
• Primary Completion: August 2, 2021
• Study Completion: August 2, 2021
• Last Updated: October 25, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)