Lakeshore Examination of Activity and Disability Exercise Response Study

NCT ID: NCT02533882

Last Updated: 2019-10-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2019-08-30

Brief Summary

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This study will examine the effectiveness of two types of group exercise classes on the health and functional status in inactive adults age 18-65 with neurological conditions including Multiple Sclerosis, stroke, and spinal cord injury (SCI). Participants will be randomly assigned to one of three groups; Movement to Music, Adapted Yoga, or a waitlist group who will complete a home-based exercise intervention of either Movement to Music or Adapted Yoga.

Detailed Description

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Conditions

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Multiple Sclerosis Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Movement to Music

Intervention Type BEHAVIORAL

Adapted Yoga

Yoga classes will consist of postures adapted by qualified yoga instructors who have extensive experience in disability.

Group Type ACTIVE_COMPARATOR

Adapted Yoga

Intervention Type BEHAVIORAL

Waitlist Control

This group will receive biweekly newsletters on a variety of topics. At the end of this trial, they will receive a home based intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Movement to Music

Intervention Type BEHAVIORAL

Adapted Yoga

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with stroke
* MS - mild to moderate disability (Patient Determined Disease Steps Score 0-6)
* Able to use arms or arms/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

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Lakeshore Foundation

OTHER

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

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James Rimmer

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Lakeshore Foundation

Birmingham, Alabama, United States

Site Status

Countries

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United States

References

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Young HJ, Mehta TS, Herman C, Wang F, Rimmer JH. The Effects of M2M and Adapted Yoga on Physical and Psychosocial Outcomes in People With Multiple Sclerosis. Arch Phys Med Rehabil. 2019 Mar;100(3):391-400. doi: 10.1016/j.apmr.2018.06.032. Epub 2018 Aug 6.

Reference Type DERIVED
PMID: 30092206 (View on PubMed)

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

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F140821001

Identifier Type: -

Identifier Source: org_study_id

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