SYNchronizing Exercises, Remedies in Gait and Cognition at Home (SYNERGIC@Home)

NCT04997681 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2023-10-02

No results posted yet for this study

Summary

Background: Prevention of Alzheimer's Disease and Related Dementias (ADRDs) may be possible for persons with subjective (SCI) or mild cognitive impairment (MCI), or normal cognition and risk factors. Physical exercise and cognitive training have been shown to enhance cognitive function and mobility in MCI when delivered in a research facility. The feasibility of delivering interventions in the home of older adults at risk for developing ADRDs is not known. What preferences the participants have for these interventions are also unknown. The primary goals are: 1) assess feasibility of a home-based delivery of exercise and cognitive interventions 2) evaluate the relationship between participants' intervention preferences and adherence. Secondary objectives focus on cognition, frailty, mobility, sleep, diet and mental health.

Methods and analysis: SYNERGIC@Home is a randomized control trial (using a 2 x 2 factorial design) with a 16-week home-based intervention program of physical exercises with cognitive training. Sixty-four participants will be randomized in blocks of four: 1) combined exercise (aerobic and resistance) + cognitive training (NEUROPEAK™); 2) combined exercise + control cognitive training (web searching); 3) control exercise (balance and toning) + cognitive training; and 4) control exercise + control cognitive training. It will be implemented virtually through video conferencing. Baseline, 4- and 10-month post-intervention will include measures of cognition, frailty, mobility, sleep, diet, and psychological health. Feasibility outcomes include recruitment and retention. Preference will be used to determine the relationship between preference adherence. Secondary outcomes will evaluate the effect of the interventions on cognitive, mobility, and general well-being.

Conditions

Interventions

BEHAVIORAL

Combined Aerobic Exercise and Resistance Training (AE + RT)

AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.

BEHAVIORAL

Cognitive Training (NeuropeakTM)

NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.

BEHAVIORAL

Control Cognitive Training of Website Searching and Video Watching (WS+V)

During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.

BEHAVIORAL

Control Balance and Toning Exercise Training (BAT)

BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.

Sponsors & Collaborators

  • Horizon Health Network

    collaborator OTHER
  • Réseau de Santé Vitalité Health Network

    collaborator OTHER
  • Universite de Moncton

    collaborator OTHER
  • Western University, Canada

    collaborator OTHER
  • University of New Brunswick

    lead OTHER

Principal Investigators

  • Chris McGibbon, PhD · University of New Brunswick

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
60 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-28
Primary Completion
2023-03-08
Completion
2023-07-27

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04997681 on ClinicalTrials.gov