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E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02938000
Recruitment Status : Completed
First Posted : October 19, 2016
Last Update Posted : August 22, 2018
Sponsor:
Information provided by (Responsible Party):
Kaiser Permanente

Brief Summary:
This pilot study intends to evaluate an online exercise video rehabilitation program for stroke survivors with moderate disability compared to usual care. The intervention videos combine aerobic and resistance training using a latex resistance band, Thera band® elastic band, specifically designed for rehabilitation. This study will aim to show that for patients suffering acute ischemic stroke resulting in disability, at-home physical therapy with aerobic exercise videos will improve depression level and aerobic capacity more than usual care.

Condition or disease Intervention/treatment Phase
Stroke Hemiplegia Device: Theraband with exercise video Other: usual care with advice to exercise Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: E-Rehabilitation: Aerobic Resistance Training for Stroke Survivors
Study Start Date : August 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Theraband group
This group will be furnished with Thera-band, and link to exercise video, with plans for regular exercise as described previously, in addition to usual post stroke care.
Device: Theraband with exercise video
Theraband exercise band for resistance training

Placebo Comparator: Usual Care Group
This group will have usual post stroke care, and will be advised to get regular exercise.
Other: usual care with advice to exercise
advice to exercise




Primary Outcome Measures :
  1. VO2: aerobic capacity measurement with peak VO2 using 6 minute walk test [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Berg Balance Score [ Time Frame: 12 weeks ]
    standardized questionnaire to assess balance difficulty following stroke.

  2. adherence to exercise program, interventional group only [ Time Frame: 12 weeks ]
    participants will be asked how many exercise sessions they have completed in the time frame.

  3. Patient Health Questionnaire - 9 (PHQ 9) [ Time Frame: 12 weeks ]
    standardized assessment for depression following stroke



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • acute ischemic stroke within 2 weeks of enrollment

Exclusion Criteria:

  • unstable coronary artery disease, oxygen dependent, with oxygen saturation less than 92% on room air, unable to perform peak oxygen consumption testing, musculoskeletal disease limiting exercise performance.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938000


Locations
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United States, California
Kaiser Permanente
San Diego, California, United States, 92120
Sponsors and Collaborators
Kaiser Permanente
Investigators
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Principal Investigator: William P Neil, MD Kaiser Permanente
Publications:
McCarthy D, Mueller K, Wrenn J. Kaiser Permanente: Bridging the Quality Divide with Integrated Practice, Group Accountability, and Health Information Technology2009.
Andersen LL. Muscle activity during rehab exercises with Thera-band vs machine exercise. Proceedings of the 16th TRAC meeting; 2014 August 6-8, 2014; Park City, Utah. p. 16.

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT02938000    
Other Study ID Numbers: IRB # 10926
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Kaiser Permanente:
aerobic training
stroke
exercise
stroke recovery
Additional relevant MeSH terms:
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Stroke
Hemiplegia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms