NCT01003353

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started Nov 2009

Shorter than P25 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2009

Completed
4 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

June 25, 2012

Status Verified

June 1, 2012

Enrollment Period

4 months

First QC Date

October 27, 2009

Last Update Submit

June 22, 2012

Conditions

Stroke

Keywords

StrokeStrength trainingexercise therapy

Outcome Measures

Primary Outcomes (1)

  • Unilateral 1 repetition maximum for leg press and plantarflexion

    November 2009-March 2010

Secondary Outcomes (9)

  • Rate of force development in unilateral leg press and plantarflexion

    November 2009 - March 2010

  • Maximal oxygen uptake and walking economy

    November 2009 - March 2010

  • Timed Up and Go Test

    November 2009 - March 2010

  • 4 Step Balance Test

    November 2009 - March 2010

  • V-Wave (using sEMG equipment) of soleus during static plantarflexion

    November 2009 - March 2010

  • +4 more secondary outcomes

Interventions

Maximal strength trainingBEHAVIORAL

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.

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Avdeling for ervervede hjerneskader, Klinikk for fysikalsk medisin og rehabilitering, St Olavs Hospital

Trondheim, 7050, Norway

Location

Related Publications (1)

  • 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.

    PMID: 22357133RESULT

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Tom Tørhaug, MD

    St.Olav's University hospital

    PRINCIPAL INVESTIGATOR

  • Jan Hoff, PhD

    National Taiwan Normal University

    STUDY CHAIR

  • Jan Helgerud

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Tor Ivar Gjellesvik

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Marius Fimland

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Per Marius R Moen

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

  • Tessa Hill

    National Taiwan Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2009

First Posted

October 28, 2009

Study Start

November 1, 2009

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

June 25, 2012

Record last verified: 2012-06

Locations

NO(1)