Remote Balance Training for Individuals With Dementia

NCT05558215 | Unknown

• 1 other identifier: ARDRAF 22-3
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

Individuals with dementia (IwDs) fall more and are more seriously injured in falls than their age-matched, cognitively intact peers. An accessible and sustainable fall prevention program would be of great value. Using remote technology has become commonplace during the COVID-19 pandemic, and Marymount University's new Center for Optimal Aging plans to use this technology to bring a web-based version of a well-established and accepted evidence-based fall prevention intervention, the Otago Exercise Program, into the homes of IwDs and their care partners. Care partners will be trained in the home for safety and oversight of their exercising partner with dementia. Dyads of IwD and care partners will access the online exercise program through an online Learning Management System (Canvas) three times per week which tracks their access to exercise videos. Once per week, exercise will take place in a Zoom format with a small cohort of other dyads, supervised by a research team member, and the other two times will be independent access of exercise videos. The purpose of this study is to determine the viability of remote administration of the Otago Exercise Program by assessing program functionality, utility, and effectiveness. Feasibility will be evaluated by using components of the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, and Maintenance). The results will guide and inform adaptations of future remote training efforts for IwD, with implications at the individual, family, and societal levels.

Conditions

Dementia

Keywords

Balance; Exercise; Dementia

Outcome Measures

Primary Outcomes (4)

• Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in 4-Stage Balance Test (4-SBT)

  The participant will stand with feet in four different positions and be timed for up to 10 seconds in each position. The positions are: (1) feet side by side, (2) staggered stance with feet next to each other, (3) one foot in front of the other, and (4) standing on one foot.

  Assessed at Weeks 0, 8, and 16

• Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in 30-second Sit to Stand (30s STS)

  The number of stands completed in 30 seconds without use of arms from a standard kitchen or dining room chair (standard test is with 17-inch seat to floor height).

  Assessed at Weeks 0, 8, and 16

• Change over time (immediate post-intervention, delayed post-intervention) in Adherence / Participation

  Measured by attendance \& participation at synchronous sessions and by number of "views" recorded through Canvas website for asynchronous sessions.

  Assessed at Weeks 8 and 16

• Change over time (immediate post-intervention, delayed post-intervention) in System Usability Scale (SUS)

  SUS is a 10-item Likert survey and scores are between 0-100 with higher scores representing better usability.

  Assessed at Weeks 8 and 16

Secondary Outcomes (4)

• Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Timed Up and Go (TUG)

  Assessed at Weeks 0, 8, and 16

• Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Short Falls Efficacy Scale-International (Short FES-I)

  Assessed at Weeks 0, 8, and 16

• Change over time (pre-intervention, immediate post-intervention, delayed post-intervention) in Burden Scale for Family Caregivers-Short Version (BSFC).

  Assessed at Weeks 0, 8 and 16

• Change over time (pre-intervention and delayed post-intervention) in Montreal Cognitive Assessment (MoCA).

  Assessed at Weeks 0 and 16

Study Arms (1)

Remote Otago Exercise Program

EXPERIMENTAL

Individuals with dementia will participate in Otago Exercise Program in their home using video recordings and with safety oversight by their trained care partners.

Other: Otago Exercise Program

Interventions

Otago Exercise Program OTHER

The Otago Exercise Program (OEP) is a CDC endorsed evidence-based falls prevention program for older adults. It has not been well studied with individuals with dementia. It is comprised of a brief "warm up"/flexibility series, lower extremity strengthening, and balance exercises. The same menu of exercises is used for all participants, but exercises are progressed based upon individual performance. For the purposes of this study, three 25-minute video recorded versions of OEP will be rotated for use, all of which include brief flexibility activities, strengthening, and balance exercises. Strengthening exercises will be limited to body weight resistance for ease of instruction, safety, and consistency. Balance exercises involve changes in base of support in static and dynamic contexts, with challenge progressively increased by decreasing arm support during training (from 2-hands, to 1-hand, to no hands).

Also known as: Modified Otago Exercise Program

Remote Otago Exercise Program

Eligibility Criteria

• Age: 60 Years+
• Gender Eligibility Details: Gender data collected will be participant's self-identified gender.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English-speaking, community-dwelling adults \>60 years old
• Physician's confirmed diagnosis of mild to moderate dementia

You may not qualify if:

• Ability to walk indoors without assistive device or physical assistance of another person
• Ability to follow one-step commands
• A committed care provider / person responsible willing to supervise exercise sessions 3x/wk
• Use of assistive device or furniture for indoor walking
• Advanced dementia
• Acute / severe psychiatric condition
• Unstable or limiting systemic pathology (e.g., cardiac, pulmonary, metabolic, orthopedic, neurologic)
• Recent (within 6 months) major surgical intervention (for any reason) or treatment for cancer
• Neurological diagnosis/condition with residual deficit (e.g., stroke, Parkinson's Disease).
• English speaking
• Cognitively \& physically capable of providing safety oversight to IwD during balance training program
• Has computer /tablet with internet access for use in the home of the IwD
• Committed to overseeing IwD for exercise program 3x/week
• Willing to maintain fall diary and participate in providing data for feasibility measures.
• Uses assistive device for mobility

Sponsors & Collaborators

• Marymount University: lead
• Virginia Commonwealth University: collaborator

Study Sites (1)

Marymount University

Arlington, Virginia, 22201, United States

Location

Related Publications (5)

• Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health. 1999 Sep;89(9):1322-7. doi: 10.2105/ajph.89.9.1322.

  PMID: 10474547 BACKGROUND

• Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019.

  PMID: 30984733 BACKGROUND

• Suttanon P, Hill KD, Said CM, Williams SB, Byrne KN, LoGiudice D, Lautenschlager NT, Dodd KJ. Feasibility, safety and preliminary evidence of the effectiveness of a home-based exercise programme for older people with Alzheimer's disease: a pilot randomized controlled trial. Clin Rehabil. 2013 May;27(5):427-38. doi: 10.1177/0269215512460877. Epub 2012 Nov 1.

  PMID: 23117349 BACKGROUND

• Taylor ME, Close JCT, Lord SR, Kurrle SE, Webster L, Savage R, Delbaere K. Pilot feasibility study of a home-based fall prevention exercise program (StandingTall) delivered through a tablet computer (iPad) in older people with dementia. Australas J Ageing. 2020 Sep;39(3):e278-e287. doi: 10.1111/ajag.12717. Epub 2019 Sep 19.

  PMID: 31538401 BACKGROUND

• Osho O, Owoeye O, Armijo-Olivo S. Adherence and Attrition in Fall Prevention Exercise Programs for Community-Dwelling Older Adults: A Systematic Review and Meta-Analysis. J Aging Phys Act. 2018 Apr 1;26(2):304-326. doi: 10.1123/japa.2016-0326. Epub 2018 Apr 23.

  PMID: 28771111 BACKGROUND

MeSH Terms

Conditions

Dementia; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior

Study Officials

• Patricia C Heyn, PhD

  Marymount University Center for Optimal Aging

  STUDY DIRECTOR

• Rita Wong, EdD

  Marymount University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Physical Therapy, Research Fellow of Center for Optimal Aging

Model Details: Single group clinical trial with single arm to assess feasibility of remote administration of balance training

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: September 28, 2022
• Study Start: October 15, 2022
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: December 14, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)