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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01003353
Other study ID # 2009/1241
Secondary ID
Status Completed
Phase N/A
First received October 27, 2009
Last updated June 22, 2012
Start date November 2009
Est. completion date March 2010

Study information

Verified date June 2012
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical 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.

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 67 Years
Eligibility 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Maximal strength training
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.

Locations

Country Name City State
Norway Avdeling for ervervede hjerneskader, Klinikk for fysikalsk medisin og rehabilitering, St Olavs Hospital Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Hill TR, Gjellesvik TI, Moen PM, Tørhaug 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.0b013e31824ad5b — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Unilateral 1 repetition maximum for leg press and plantarflexion November 2009-March 2010 No
Secondary Rate of force development in unilateral leg press and plantarflexion November 2009 - March 2010 No
Secondary Maximal oxygen uptake and walking economy November 2009 - March 2010 No
Secondary Timed Up and Go Test November 2009 - March 2010 No
Secondary 4 Step Balance Test November 2009 - March 2010 No
Secondary V-Wave (using sEMG equipment) of soleus during static plantarflexion November 2009 - March 2010 No
Secondary Blood lipid profile November 2009 - March 2010 No
Secondary 6 Minute Walk Test November 2009 - March 2010 No
Secondary Jump Height of a countermovement jump November 2009 - March 2010 No
Secondary SF-36 Quality of life questionnaire, Norwegian version November 2009 - March 2010 No
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