NCT05134870

Brief Summary

The composite effect of reduced balance, cognition, gait abnormalities/gait disturbances, and physical activity in older adults leads to fear of falling and decreased participation in daily activities, resulting in reduced cardiovascular fitness and deconditioning. Although many conventional balance and strength training programs have been implemented for older adults, these adults do not receive adequate practice dosage to make significant improvements, most likely due to lack of adherence to therapy and/or inadequate incorporation of all domains of the ICF model (body functions and structures, activities and participation) and lack of targeting cognitive-motor interference (deterioration of motor and/or cognitive function when both tasks are performed together). The use of TeleXercise via Tele rehabilitation has been found to be relatively enjoyable for older adults due to increased motivation and adherence to therapy, which led to the added improvement of physical and cognitive functioning. The overall aim of this pilot is to develop and test the Mimic-Me \& Groove TeleXercise platform and then evaluate the compliance and efficacy of the TeleXercise intervention compared to control group receiving standard of care (education on conventional exercise and fall prevention program) for older adults as well as its effect on enhancing balance, gait, and cognition, and physical activity. Investigators also hope that the net effect of improvement in these domains of health outcomes will result in pre and post improvement in endurance and cardiovascular function and reduction of fall risk and improved quality of life of older adults. The study investigates the efficacy of a TeleXercise intervention in older adults by demonstrating its feasibility, compliance rate and also determine the efficacy of the Mimic-Me \& Groove TeleXercise in improving health outcomes such as motor and cognitive functions, thereby reducing cognitive-motor interference. The study will also aim to determine the effectiveness of the TeleXercise in improving cardiovascular fitness and physical activity (PA) in older adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 28, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 13, 2021

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2023

Completed
Last Updated

May 16, 2024

Status Verified

May 1, 2024

Enrollment Period

2.5 years

First QC Date

August 13, 2021

Last Update Submit

May 14, 2024

Conditions

Keywords

Tele-rehabilitationTeleXerciseMimic-Game-&Groove

Outcome Measures

Primary Outcomes (6)

  • Change in time during 30-second chair stand test.

    This test is conducted to assess leg strength and endurance.

    Change in time from pre-test (Week 0) to post-training (week 5)

  • Change in time during four-step square test

    To test the dynamic balance and to assess the person's ability to step over objects forward, sideways, and backwards

    Change in time from pre-test (Week 0) to post-training (week 5)

  • Change in time during Sharpened Romberg

    To assess the static balance of participants in sensory integration taxing condition

    Change in time from pre-test (Week 0) to post-training (week 5)

  • Change in time during 2-minute step in place test

    To assess the cardiovascular exercise tolerance

    Change in time from pre-test (Week 0) to post-training (week 5)

  • Change in time during One-legged Stance test

    To assess the static balance of participants in sensory integration taxing condition

    Change in time from pre-test (Week 0) to post-training (week 5)

  • Change in time during Tinetti Performance Oriented Mobility Assessment

    To assess gait and balance together

    Change in time from pre-test (Week 0) to post-training (week 5)

Secondary Outcomes (13)

  • Change in correct responses during Letter Number sequencing test

    Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  • Change in correct responses during Visual stroop test

    Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  • Change in correct responses during Auditory stroop

    Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  • Change in correct response during Flanker inhibitory control and attention test

    Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  • Change in correct response during List Sorting Memory test

    Change in number of correct response from pre-test (Week 0) to post-training (week 5)

  • +8 more secondary outcomes

Study Arms (1)

TeleXercise intervention

EXPERIMENTAL

TeleXercise intervention will be delivered via exergaming-based animation videos combined with or without cognitive exercises by a health coach. Participants will need a computer/tablet/smart phone for the study. The health coach will launch the exercise application on their computer and share their screen with the participants. They have to mimic the exercises shown to them. The intervention will have 12 sessions for 4 weeks, each session for 1.5 hours, including warm-ups and cool-down. Warm-up and cool down are for 20 minutes. A wearable device provided will measure the heart rate and physical activity during the training. Participants are provided with a set of balance exercises which includes non-interactive balance games (stepping forward, backward, sideways), Tai-Chi, Weight shifting (to right leg, left leg and practice distributing equal weights on both the legs), Aerobic (stepping in place), dance, strength, and stretching

Behavioral: Mimic- game and groove- Telerehabilitation

Interventions

Participants will mimic the exergaming-based animation videos shown to them by the health coach. They will also wear a wearable device that will measure the heart rate and physical activity during the training. The intervention will have 12 sessions for 4 weeks, each session for 1.5 hours, including warm-ups and cool-down. Warm-up and cool down are for 20 minutes. Additionally, Participants are provided with a set of balance exercises which includes non-interactive balance games (stepping forward, backward, sideways), Tai-Chi, Weight shifting (to right leg, left leg and practice distributing equal weights on both the legs), Aerobic (stepping in place), dance, strength, and stretching

Also known as: Tele rehabilitation
TeleXercise intervention

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age group: Community-dwelling healthy older adults between the age group of 55 - 85 years
  • Participants without any history of fracture for the last 1 year
  • Should have either a desktop computer/laptop/tablet and a WIFI connection.
  • Absence of any acute or chronic neurological (Stroke, Parkinson's disease, Alzheimer's disease), cardiopulmonary, musculoskeletal, or systemic diagnosis.
  • No recent major surgery (\< 6 months) or hospitalization (\< 3 months)
  • Not on any sedative drugs
  • Can understand and communicate in English

You may not qualify if:

  • Participants will not proceed with the study if at baseline measurement HR \> 85% of age-predicted maximal heart rate (HRmax) (HRmax = 220 - age)
  • Inability to stand for at least 5 minutes without an assistive device (length of each exercise)
  • History of bone fracture or significant other systemic disease or surgery in the last six months
  • Uncontrolled acute medical, surgical, neurological or cardiovascular disease.
  • Moderate to severe cognitive impairment (MOCA \<24/30)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesTelemedicineDelivery of Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Tanvi S Bhatt, PhD

    University of Illinois at Chicago

    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
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

August 13, 2021

First Posted

November 26, 2021

Study Start

August 28, 2020

Primary Completion

February 20, 2023

Study Completion

July 30, 2023

Last Updated

May 16, 2024

Record last verified: 2024-05

Locations