NCT02938000

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Aug 2016

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 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 17, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 19, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

7 months

First QC Date

October 17, 2016

Last Update Submit

August 21, 2018

Conditions

Keywords

aerobic trainingstrokeexercisestroke recovery

Outcome Measures

Primary Outcomes (1)

  • VO2: aerobic capacity measurement with peak VO2 using 6 minute walk test

    12 weeks

Secondary Outcomes (3)

  • Berg Balance Score

    12 weeks

  • adherence to exercise program, interventional group only

    12 weeks

  • Patient Health Questionnaire - 9 (PHQ 9)

    12 weeks

Study Arms (2)

Theraband group

EXPERIMENTAL

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

Usual Care Group

PLACEBO COMPARATOR

This group will have usual post stroke care, and will be advised to get regular exercise.

Other: usual care with advice to exercise

Interventions

Theraband exercise band for resistance training

Theraband group

advice to exercise

Usual Care Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • acute ischemic stroke within 2 weeks of enrollment

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaiser Permanente

San Diego, California, 92120, United States

Location

Related Publications (29)

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    BACKGROUND
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    PMID: 17303771BACKGROUND
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    PMID: 16032913BACKGROUND
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  • 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.

    BACKGROUND
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    PMID: 21555984BACKGROUND
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MeSH Terms

Conditions

StrokeHemiplegiaMotor Activity

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • William P Neil, MD

    Kaiser Permanente

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2016

First Posted

October 19, 2016

Study Start

August 1, 2016

Primary Completion

March 1, 2017

Study Completion

August 1, 2017

Last Updated

August 22, 2018

Record last verified: 2018-08

Locations