Strength Training for Chronic Stroke Patients
Primary Purpose
Stroke
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Maximal strength training
Sponsored by
About this trial
This is an interventional treatment trial for Stroke focused on measuring Stroke, Strength training, exercise therapy
Eligibility Criteria
Inclusion Criteria:
- Under 67 years old
- Suffered from a stroke at least 6 months previously
- Living in the Trondheim area such that travel costs can be covered by 1500 NOK
- Must be able to walk, although use of aids is permitted
Exclusion Criteria:
- Participants must not have cognitive, visuospatial or comprehension deficits to magnitude such that it interferes with the ability to perform testing and training
- Participants must be medically unstable (e.g. uncontrollably high blood pressure (140/90), arrythmia, other heart instabilities or other known comorbid diseases)
- Participants must not be known to be pregnant
Sites / Locations
- Avdeling for ervervede hjerneskader, Klinikk for fysikalsk medisin og rehabilitering, St Olavs Hospital
Outcomes
Primary Outcome Measures
Unilateral 1 repetition maximum for leg press and plantarflexion
Secondary Outcome Measures
Rate of force development in unilateral leg press and plantarflexion
Maximal oxygen uptake and walking economy
Timed Up and Go Test
4 Step Balance Test
V-Wave (using sEMG equipment) of soleus during static plantarflexion
Blood lipid profile
6 Minute Walk Test
Jump Height of a countermovement jump
SF-36 Quality of life questionnaire, Norwegian version
Full Information
NCT ID
NCT01003353
First Posted
October 27, 2009
Last Updated
June 22, 2012
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01003353
Brief Title
Strength Training for Chronic Stroke Patients
Official Title
Maximal Strength Training for Chronic Phase Stroke Patients
Study Type
Interventional
2. Study Status
Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study aims to investigate the effects of strength training on maximal strength, walking ability and neural function in chronic stroke patients. The strength training intervention in this study is different to all previous interventions for stroke patients.
Maximal Strength Training (MST) involves weights of up to 90% of the participants 1 repetition maximum and has a focus on the explosive development of force. This study will use these principles for unilateral leg press and plantarflexion exercises. Only 2 previous studies have investigated high intensity strength training for stroke patients and they used intensities of 80% 1RM. Previous MST interventions have shown large increases in strength, rate of force development and this has transferred to improved walking economy.
The investigators predict that MST will give large increases in strength, improved rate of force development (RFD) and walking economy. The investigators expect that better neural function will account for the improvements. This study could provide evidence for the adoption of a completely different method of strength rehabilitation for stroke survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Stroke, Strength training, exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Maximal strength training
Intervention Description
Training will be carried out 3 times a week for 8 weeks. Each session will include a warm up, strength training and warm down. The total time will be approximately 1 hour. The training will consist 2 exercises (leg press and plantarflexion). Participants will train each leg individually with 4 sets of 4 repetitions at 90% of the 1 repetition maximum.
Primary Outcome Measure Information:
Title
Unilateral 1 repetition maximum for leg press and plantarflexion
Time Frame
November 2009-March 2010
Secondary Outcome Measure Information:
Title
Rate of force development in unilateral leg press and plantarflexion
Time Frame
November 2009 - March 2010
Title
Maximal oxygen uptake and walking economy
Time Frame
November 2009 - March 2010
Title
Timed Up and Go Test
Time Frame
November 2009 - March 2010
Title
4 Step Balance Test
Time Frame
November 2009 - March 2010
Title
V-Wave (using sEMG equipment) of soleus during static plantarflexion
Time Frame
November 2009 - March 2010
Title
Blood lipid profile
Time Frame
November 2009 - March 2010
Title
6 Minute Walk Test
Time Frame
November 2009 - March 2010
Title
Jump Height of a countermovement jump
Time Frame
November 2009 - March 2010
Title
SF-36 Quality of life questionnaire, Norwegian version
Time Frame
November 2009 - March 2010
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Under 67 years old
Suffered from a stroke at least 6 months previously
Living in the Trondheim area such that travel costs can be covered by 1500 NOK
Must be able to walk, although use of aids is permitted
Exclusion Criteria:
Participants must not have cognitive, visuospatial or comprehension deficits to magnitude such that it interferes with the ability to perform testing and training
Participants must be medically unstable (e.g. uncontrollably high blood pressure (140/90), arrythmia, other heart instabilities or other known comorbid diseases)
Participants must not be known to be pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tom Tørhaug, MD
Organizational Affiliation
St.Olav's University hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Hoff, PhD
Organizational Affiliation
National Taiwan Normal University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jan Helgerud
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tor Ivar Gjellesvik
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marius Fimland
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Per Marius R Moen
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tessa Hill
Organizational Affiliation
National Taiwan Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Avdeling for ervervede hjerneskader, Klinikk for fysikalsk medisin og rehabilitering, St Olavs Hospital
City
Trondheim
ZIP/Postal Code
7050
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22357133
Citation
Hill TR, Gjellesvik TI, Moen PM, Torhaug T, Fimland MS, Helgerud J, Hoff J. Maximal strength training enhances strength and functional performance in chronic stroke survivors. Am J Phys Med Rehabil. 2012 May;91(5):393-400. doi: 10.1097/PHM.0b013e31824ad5b8.
Results Reference
result
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Strength Training for Chronic Stroke Patients
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