NCT02494518

Brief Summary

The purpose of the study is to determine if performing different types of aerobic exercise (cycling) before upper extremity exercises will help to improve outcomes after stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
Completed

Started Jul 2015

Typical duration for not_applicable stroke

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

July 1, 2015

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

July 6, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 10, 2015

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

March 28, 2019

Completed
Last Updated

March 28, 2019

Status Verified

December 1, 2018

Enrollment Period

2.1 years

First QC Date

July 6, 2015

Results QC Date

June 8, 2018

Last Update Submit

December 20, 2018

Conditions

Stroke

Keywords

strokeaerobic exerciseforced exerciserepetitive task practicearm functionupper extremity

Outcome Measures

Primary Outcomes (4)

  • Fugl Meyer Assessment

    Motor test to assess arm impairment. The reported data is the change in total score. Score range from 0-66 and higher scores represent less impairment.

    Change from baseline to midpoint (4 weeks into treatment), at end of 8 week intervention, and 4 weeks after the intervention ends

  • Wolf Motor Function Test

    Motor test to assess arm function. The reported data is the change in total Functional Ability Score. Scores range from 0-75 and higher scores represent improved function.

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Stroke Impact Scale

    Quality of life questionnaire. The reported data is the normalized Hand Function score. Scores range from 0-100, with higher scores indicating better perceived hand function.

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Metabolic Stress Test

    Cycling test to measure cardiovascular fitness. The data reported is the change in VO2peak. Higher scores indicate higher aerobic capacities.

    Change from baseline to follow up assessments at end of 8 week intervention

Secondary Outcomes (5)

  • Action Research Arm Test

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Center for Epidemiological Studies-Depression

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Processing Speed Test

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Nine Hole Peg Test

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

  • Six Minute Walk Test

    Change from baseline to end of 8 week intervention, and 4 weeks after the intervention ends

Study Arms (3)

Forced Exercise & Upper Extremity Repetitive Task Practice

ACTIVE COMPARATOR

Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises

Behavioral: Forced Exercise & Upper Extremity Repetitive Task Practice

Voluntary Exercise & Upper Extremity Repetitive Task Practice

ACTIVE COMPARATOR

Participants will perform the following: 1. 45 minutes of cycling on a recumbent stationary bike at your self-selected speed 2. 45 minutes of upper extremity repetitive arm exercises

Behavioral: Voluntary Exercise & Upper Extremity Repetitive Task Practice

Stroke Education & Upper Extremity Repetitive Task Practice

ACTIVE COMPARATOR

Participants will perform the following: 1. 45 minutes of stroke education 2. 45 minutes of upper extremity repetitive arm exercises

Behavioral: Stroke Education & Upper Extremity Repetitive Task Practice

Interventions

Forced Exercise & Upper Extremity Repetitive Task PracticeBEHAVIORAL
Forced Exercise & Upper Extremity Repetitive Task Practice
Voluntary Exercise & Upper Extremity Repetitive Task PracticeBEHAVIORAL
Voluntary Exercise & Upper Extremity Repetitive Task Practice
Stroke Education & Upper Extremity Repetitive Task PracticeBEHAVIORAL
Stroke Education & Upper Extremity Repetitive Task Practice

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to provide informed consent
  • At least 6 months post diagnosis of single ischemic stroke, confirmed with neuroimaging
  • Fugl-Meyer Motor Score 19-55 in involved upper extremity
  • Approval from patient's physician
  • Age between 18 and 85 years

You may not qualify if:

  • Hospitalization for myocardial infarction, congestive heart failure, or heart surgery (CABG or valve replacement) within 3 months of study enrollment
  • Serious cardiac arrhythmia
  • Other serious heart and lung conditions (i.e.cardiomyopathy, aortic stenosis, cardiac pacemaker, pulmonary embolus)
  • Other medical or musculoskeletal contraindication to exercise
  • Significant cognitive impairment (unable to follow 1-2 step commands) or major psychiatric disorder (major depression, generalized anxiety) that will cause difficulty in study participation
  • Anti-spasticity injection (botox) in upper extremity within 3 months of study enrollment
  • Pregnancy
  • Unstable blood pressure at rest or with exercise

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Related Publications (3)

  • Linder SM, Davidson S, Rosenfeldt A, Lee J, Koop MM, Bethoux F, Alberts JL. Forced and Voluntary Aerobic Cycling Interventions Improve Walking Capacity in Individuals With Chronic Stroke. Arch Phys Med Rehabil. 2021 Jan;102(1):1-8. doi: 10.1016/j.apmr.2020.08.006. Epub 2020 Sep 9.

    PMID: 32918907DERIVED

  • Linder SM, Davidson S, Rosenfeldt A, Penko A, Lee J, Koop MM, Phelan D, Alberts JL. Predictors of Improved Aerobic Capacity in Individuals With Chronic Stroke Participating in Cycling Interventions. Arch Phys Med Rehabil. 2020 Apr;101(4):717-721. doi: 10.1016/j.apmr.2019.10.187. Epub 2019 Nov 25.

    PMID: 31778659DERIVED

  • Rosenfeldt AB, Linder SM, Davidson S, Clark C, Zimmerman NM, Lee JJ, Alberts JL. Combined Aerobic Exercise and Task Practice Improve Health-Related Quality of Life Poststroke: A Preliminary Analysis. Arch Phys Med Rehabil. 2019 May;100(5):923-930. doi: 10.1016/j.apmr.2018.11.011. Epub 2018 Dec 10.

    PMID: 30543801DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Susan Linder
Organization
Cleveland Clinic
linders@ccf.org
(216) 445-9815

Study Officials

  • Susan Linder, PT, DPT, NCS

    The Cleveland Clinic

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Physical Therapist

Study Record Dates

First Submitted

July 6, 2015

First Posted

July 10, 2015

Study Start

July 1, 2015

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

March 28, 2019

Results First Posted

March 28, 2019

Record last verified: 2018-12

Locations

US(1)