The effects of strEngth aNd BaLance exercise on Executive function in people living with Dementia (ENABLED): Study protocol for a pilot randomized controlled trial

Deborah A Jehu; Yanbin Dong; Haidong Zhu; Ying Huang; Andre Soares; Charmi Patel; Zak Aden; Colleen Hergott; Brittany Ange; Jennifer L Waller; Lufei Young; William Hall; Dawnchelle Robinson-Johnson; Crystal Allen; Richard Sams; Mark Hamrick

doi:10.1016/j.cct.2023.107220

The effects of strEngth aNd BaLance exercise on Executive function in people living with Dementia (ENABLED): Study protocol for a pilot randomized controlled trial

Contemp Clin Trials. 2023 Jul:130:107220. doi: 10.1016/j.cct.2023.107220. Epub 2023 May 6.

Authors

Deborah A Jehu¹, Yanbin Dong², Haidong Zhu³, Ying Huang⁴, Andre Soares⁵, Charmi Patel⁶, Zak Aden⁷, Colleen Hergott⁸, Brittany Ange⁹, Jennifer L Waller¹⁰, Lufei Young¹¹, William Hall¹², Dawnchelle Robinson-Johnson¹³, Crystal Allen¹⁴, Richard Sams¹⁵, Mark Hamrick¹⁶

Affiliations

¹ Interdisciplinary Health Sciences Department, College of Allied Health Sciences, Augusta University, Augusta, GA, USA. Electronic address: djehu@augusta.edu.
² Georgia Prevention Institute, Augusta University, Augusta, GA, USA. Electronic address: ydong@augusta.edu.
³ Georgia Prevention Institute, Augusta University, Augusta, GA, USA. Electronic address: hzhu@augusta.edu.
⁴ Georgia Prevention Institute, Augusta University, Augusta, GA, USA. Electronic address: yihuang@augusta.edu.
⁵ Interdisciplinary Health Sciences Department, College of Allied Health Sciences, Augusta University, Augusta, GA, USA. Electronic address: ansoares@augusta.edu.
⁶ Interdisciplinary Health Sciences Department, College of Allied Health Sciences, Augusta University, Augusta, GA, USA. Electronic address: cpatel5@augusta.edu.
⁷ Interdisciplinary Health Sciences Department, College of Allied Health Sciences, Augusta University, Augusta, GA, USA. Electronic address: zaden@augusta.edu.
⁸ Physical Therapy Department, College of Allied Health Sciences, Augusta University, USA. Electronic address: chergott@augusta.edu.
⁹ Department of Population Health Sciences, Division of Biostatistics and Data Science, Augusta University, USA. Electronic address: bange@augusta.edu.
¹⁰ Department of Population Health Sciences, Division of Biostatistics and Data Science, Augusta University, USA. Electronic address: jwaller@augusta.edu.
¹¹ School of Nursing, University of North Carolina, Charlotte, NC, USA. Electronic address: lyoung57@uncc.edu.
¹² Claiborne Assisted Living Facility, GA College of Nursing, Augusta University, Augusta, GA, USA. Electronic address: whall@theclaiborne.com.
¹³ Claiborne Assisted Living Facility, GA College of Nursing, Augusta University, Augusta, GA, USA. Electronic address: drobinsonjohnson@theclaiborne.com.
¹⁴ Georgia War Veterans Nursing Home, Augusta, GA, USA. Electronic address: callen11@augusta.edu.
¹⁵ Georgia War Veterans Nursing Home, Augusta, GA, USA. Electronic address: risams@augusta.edu.
¹⁶ Department of Cellular Biology and Anatomy, Medical College of Georgia, Augusta University, Augusta, GA, USA. Electronic address: mhamrick@augusta.edu.

PMID: 37156373
PMCID: PMC10330466 (available on 2024-07-01)
DOI: 10.1016/j.cct.2023.107220

Abstract

Background: Exercise may improve executive function among people living with all-cause dementia (PWD), but more evidence is needed. The aim of this pilot randomized controlled trial (RCT) is to examine whether exercise plus usual care improves the primary outcome of executive function, and secondary physiological (inflammation, metabolic aging, epigenetics) and behavioral (cognition, psychological health, physical function, and falls) outcomes compared to usual care alone among PWD.

Methods and study design: The strEngth aNd BaLance exercise on Executive function in people living with Dementia (ENABLED) protocol is a pilot parallel, 6-month assessor-blinded RCT (1:1) in residential care facilities, including n = 21 receiving exercise plus usual care and n = 21 usual care alone [NCT05488951]. We will collect primary (Color-Word Stroop Test) and secondary physiological (inflammation, metabolic aging, epigenetics) and behavioral (cognition, psychological health, physical function, and falls) outcomes at baseline and 6 months. We will obtain falls monthly from medical charts. We will collect physical activity, sedentary behavior, and sleep via wrist-worn accelerometers over 7 days at baseline and 6 months. The physical therapist-led adapted Otago Exercise Program will involve 1-h of strength, balance and walking 3×/week for 6 months in groups of 5-7. We will use generalized linear mixed models to examine differences over time in primary and secondary outcomes between groups and examine potential interactions with sex and race.

Discussion: This pilot RCT will examine the direct effects and potential underlying physiological mechanisms of exercise on executive function and other behavioral outcomes in PWD, which may have implications for clinical care management.

Keywords: Balance; Dementia; Executive function; Exercise; Falls; Inflammation.

Publication types

Clinical Trial Protocol
Research Support, Non-U.S. Gov't

MeSH terms

Dementia*
Executive Function*
Exercise Therapy / methods
Female
Humans
Inflammation
Male
Pilot Projects
Postural Balance
Randomized Controlled Trials as Topic

Grants and funding

P01 AG036675/AG/NIA NIH HHS/United States