Reshaping Exercise Habits and Beliefs (REHAB)

NCT ID: NCT00431821

Last Updated: 2013-07-22

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

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2012-10-31

Brief Summary

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Regular exercise has been demonstrated to improve muscle strength, balance, coordination as well as improve cardiovascular fitness levels and overall quality of life in stroke survivors. This study is designed to test the feasibility and effectiveness of a 12-week intervention to education and encourage stroke survivors to exercise following discharge from rehabilitation settings using a walking program and targeted functional activity homework.

Detailed Description

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Conditions

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Cerebrovascular Accident Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Arm 1

Home-based exercise prescriptions with weekly motivational telephone calls.

Group Type OTHER

Exercise

Intervention Type BEHAVIORAL

Home-based exercise prescriptions with weekly motivational telephone calls.

Arm 2

Stroke education program with matched attention phone calls

Group Type OTHER

Stroke education

Intervention Type OTHER

Stroke education program with matched attention phone calls

Interventions

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Exercise

Home-based exercise prescriptions with weekly motivational telephone calls.

Intervention Type BEHAVIORAL

Stroke education

Stroke education program with matched attention phone calls

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. 40-85 years old ischemic Stroke patients,
2. Stroke onset \<90 days at enrollment,
3. Hemiparetic gait disorder,
4. Patients able to walk 30ft with or w/out assistive device,
5. Sufficient English comprehension to understand instructions, provide consent, and answer questions,
6. Lives within 30 miles of the Greater Baltimore area.

Exclusion Criteria

1. Dementia (extended MMSE \<85 or \<80 if education level below 9th grade),
2. Untreated major clinical depression (CES-D\>16) and confirmed with clinical interview,
3. Heavy alcohol use (\<3 oz liquor, 3, 4-oz glasses of wine, or 3, 12- oz beers daily),
4. Active cancer, or any illness with a life expectancy of less than 6 months,
5. Any condition in which exercise activity would be contraindicated including, but not limited to: unstable angina, cardiac ischemic event within the past 6 months, congestive heart failure (Stage III or IV), major orthopedic chronic pain or non-stroke neuromuscular disorders restricting exercise, oxygen-dependent COPD or peripheral neuropathy.
Minimum Eligible Age

40 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marianne Shaughnessy, RN PhD

Role: PRINCIPAL_INVESTIGATOR

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Locations

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Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, United States

Site Status

Countries

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United States

References

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Crocker TF, Brown L, Lam N, Wray F, Knapp P, Forster A. Information provision for stroke survivors and their carers. Cochrane Database Syst Rev. 2021 Nov 23;11(11):CD001919. doi: 10.1002/14651858.CD001919.pub4.

Reference Type DERIVED
PMID: 34813082 (View on PubMed)

Saunders DH, Mead GE, Fitzsimons C, Kelly P, van Wijck F, Verschuren O, Backx K, English C. Interventions for reducing sedentary behaviour in people with stroke. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD012996. doi: 10.1002/14651858.CD012996.pub2.

Reference Type DERIVED
PMID: 34184251 (View on PubMed)

Other Identifiers

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H24242

Identifier Type: -

Identifier Source: org_study_id

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