From Clinic to Community: An Information and Communication Technology (ICT) Home-Based Exercise Training System for Translating Clinical Findings

NCT ID: NCT03108950

Last Updated: 2019-08-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-01
• Study Completion Date: 2019-05-31

Brief Summary

The specific aim of the study in our example is to conduct a feasibility translational home-based exercise trial established in the LEADERS (R2) project with the TExt-ME tele-exercise training system for participants with neurologic disability. We hypothesize that participants in this home-based tele-exercise training program will achieve similar gains in health and function outcomes as the onsite exercise training program. Further, there will be no difference in adverse side effects (safety) between the home-based and onsite exercise treatment groups.

Detailed Description

TExT-ME is a home-based tele-exercise study providing a novel exercise program to participants with neurologic disabilities. The exercise curriculum is a Movement 2 Music (M2M) program developed during phase 2 of the grant (clinicaltrials.gov identifier NCT02533882). The exercise exercise classes are taught by trained dance instructors and are composed of a set of exercises tailored to the specific needs and capabilities of adults with neurologic disability. Each set of exercises is performed to high and low tempo music based on the individual's baseline level of function, with adjustments made to increase or decrease intensity if needed. The class consists of several training components: a) warmup (10 min.) to increase range of motion; strength/balance (15-20 min), aerobics (25-30 min. with rest periods as necessary); cool down (5 min).

The TExT-ME training and monitoring system is a user-centered design (UCD) involving a tele-exercise coach (e.g., a trained research staff person) interacting remotely with a participant in their home using video conferencing programs. Participants wear monitors to maintain safe levels of exercise and provide feedback regarding exercise intensity to the instructors. Self-reported indicators of exercise intensity are also collected using rating of perceived exertion.

Conditions

Multiple Sclerosis; Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Home-Based Movement to Music

The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.

Group Type: EXPERIMENTAL

Movement to Music

Intervention Type: BEHAVIORAL

The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.

Interventions

Movement to Music

The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.

Intervention Type: BEHAVIORAL

Other Intervention Names

M2M

Eligibility Criteria

Inclusion Criteria

• Diagnosed with stroke
• MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
• Able to use arms or arm/legs for exercise
• Ambulatory or use manual wheelchair

Exclusion Criteria

• Cognitive impairment (Mini-Mental State Exam score < 24)
• Recent weight change (+/- 25 pounds in 1 year)
• Poorly controlled blood pressure
• Cardiovascular disease event within the past six months
• Severe pulmonary disease
• Renal failure
• Current tobacco user or quit within the last six months
• Current use of medications for psychosis
• Active pressure ulcers

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lakeshore Foundation

OTHER

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

James Rimmer

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

James Rimmer, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Lakeshore Foundation

Birmingham, Alabama, United States

Countries

United States

References

Rimmer JH, Herman C, Wingo B, Fontaine K, Mehta T. Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability. BMC Med Res Methodol. 2018 Mar 14;18(1):28. doi: 10.1186/s12874-018-0480-3.

Reference Type: DERIVED

PMID: 29540164 (View on PubMed)

Other Identifiers

F160404004

Identifier Type: -

Identifier Source: org_study_id