StrokeNCT01003353
Strength Training for Chronic Stroke Patients
A study testing Maximal strength training in people with Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Stroke
- What is being tested?
- Maximal strength training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 10 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2009to Mar 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Avdeling for ervervede hjerneskader, Klinikk for fysikalsk medisin og rehabilitering, St Olavs Hospital
Trondheim, 7050
About this study
Official title: Maximal Strength Training for Chronic Phase Stroke Patients
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.
- Conditions
- Stroke
- Being tested
- Maximal strength training
- Keywords
- Stroke, Strength training, exercise therapy
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximal strength trainingBehavioural
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Unilateral 1 repetition maximum for leg press and plantarflexion
Measured: November 2009-March 2010
Secondary outcomes (9)
Rate of force development in unilateral leg press and plantarflexion
Measured: November 2009 - March 2010
Maximal oxygen uptake and walking economy
Measured: November 2009 - March 2010
Timed Up and Go Test
Measured: November 2009 - March 2010
4 Step Balance Test
Measured: November 2009 - March 2010
V-Wave (using sEMG equipment) of soleus during static plantarflexion
Measured: November 2009 - March 2010
Blood lipid profile
Measured: November 2009 - March 2010
6 Minute Walk Test
Measured: November 2009 - March 2010
Jump Height of a countermovement jump
Measured: November 2009 - March 2010
SF-36 Quality of life questionnaire, Norwegian version
Measured: November 2009 - March 2010
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2009 (estimated)
- Study startNov 2009
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Tørhaug, MD, Principal investigator, St.Olav's University hospitalJan Hoff, PhD, Study chair, National Taiwan Normal UniversityJan Helgerud, Principal investigator, National Taiwan Normal UniversityTor Ivar Gjellesvik, Principal investigator, National Taiwan Normal UniversityMarius Fimland, Principal investigator, National Taiwan Normal UniversityPer Marius R Moen, Principal investigator, National Taiwan Normal UniversityTessa Hill, Principal investigator, National Taiwan Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01003353
- Sponsor's protocol ID
- 2009/1241
- Status last verified
- Jun 2012
- First submitted
- 27 Oct 2009
- Last updated
- 25 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 22357133
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximal Strength Training for Chronic Phase Stroke Patients
- ClinicalTrials.gov ID
- NCT01003353
- Acronym / sponsor ID
- 2009/1241
- Conditions
- Stroke
- Keywords
- Stroke, Strength training, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 28 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximal strength trainingTraining 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. | Behavioural | – |
Primary outcome
Unilateral 1 repetition maximum for leg press and plantarflexion
Time frame: November 2009-March 2010
9 secondary outcomes
Rate of force development in unilateral leg press and plantarflexion
Time frame: November 2009 - March 2010
Maximal oxygen uptake and walking economy
Time frame: November 2009 - March 2010
Timed Up and Go Test
Time frame: November 2009 - March 2010
4 Step Balance Test
Time frame: November 2009 - March 2010
V-Wave (using sEMG equipment) of soleus during static plantarflexion
Time frame: November 2009 - March 2010
Blood lipid profile
Time frame: November 2009 - March 2010
6 Minute Walk Test
Time frame: November 2009 - March 2010
Jump Height of a countermovement jump
Time frame: November 2009 - March 2010
SF-36 Quality of life questionnaire, Norwegian version
Time frame: November 2009 - March 2010
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2012.
- Results publication: PubMed 22357133Hill 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.
Related trials for Stroke
Recruiting
Connectomic Alterations Following Acute Ischemic Stroke in the MCA Territory
Ischemic Stroke
RecruitingObservational study
Clevidipine for the Antihypertensive Treatment of Acute Intracerebral Hemorrhage
Intracerebral Hemorrhage, Stroke
Active, not recruitingPhase 4
A Study Testing How Well the Drug Extract of Ginkgo Biloba Leaves Tablets Works for People With Memory or Thinking Problems After a Stroke When Added to Standard Treatment
Ischemic Stroke Hospitalized, Impairment, Cognitive
Not yet recruitingPhase 4
Anti-inflammatory and Anti-thrombotic Therapy With colcHicine and Low Dose Rivaroxaban for Major Adverse Cardiovascular Events Reduction in Ischemic Stroke
Ischemic Stroke
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Tørhaug, MD principal investigator
St.Olav's University hospital
Jan Hoff, PhD study chair
National Taiwan Normal University
Jan Helgerud principal investigator
National Taiwan Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Maximal strength training in people with Stroke, run by Norwegian University of Science and Technology at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unilateral 1 repetition maximum for leg press and plantarflexion (time frame: November 2009-March 2010). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01003353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2012.