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Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Uppsala County Council, Sweden
Strokeförbundet
Uppsala University Hospital
Information provided by (Responsible Party):
karin hellstrom, Uppsala University
ClinicalTrials.gov Identifier:
NCT01161329
First received: July 12, 2010
Last updated: January 15, 2013
Last verified: January 2013
History of Changes
  Purpose

Chronic conditions such as stroke are associated with physical disability and an economic burden for the family and the society. A medical approach is often not sufficient to address the bio-psychological process of chronic disease. Behavioural medicine approaches are often needed to improve the treatment outcomes. Those approaches have often successfully been used together with physical activity to change health behaviour in inactive individuals and in pain management. In this project the combined approach of behavioural medicine principles and physical training will be tried on patients who have had a stroke one year ago where it has yet only been used scarcely. As the study focus on the individuals' ability to function and be active the primary outcome measure is disability. The aim of the study are in a randomized controlled study evaluate if a high intense functional exercise program as an group intervention under three months can influence functional, psychosocial, anthropometric and biochemical factors 3, 6 months and 1 year after the start of the study. Following outcome variables will be analyzed:

  1. level of physical activity, motor function and balance
  2. depression and health-related quality of life
  3. body mass index (BMI), metabolic risk profile, inflammation status
  4. number of falls, fall-related self-efficacy and outcome expectations

Condition Intervention Phase
Stroke
 Other: High-Intensity Functional Exercise Programmes (HIFE)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Description of Physical and Psychosocial Problems One Year After Stroke and the Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Uppsala University:

Primary Outcome Measures:
  • Physical Activity Scale for the Elderly (PASE) [ Time Frame: baseline, after 3, 6 months and after 1 year ] [ Designated as safety issue: No ]
    The instrument is comprised of self-reported occupational, household and leisure activities items over a one week period and are administrated in-person.


Secondary Outcome Measures:
  • Short Physical Performance Battery (SPPB) [ Time Frame: Baseline, after 3, 6 months and after 1 year ] [ Designated as safety issue: Yes ]
    The SPPB evaluates balance, gait, strength and endurance by examining an individual's ability to stand with feet together in side-by-side, semi-tandem and tandem positions, time to walk 8 ft and time to rise from a chair and return to the seated position five times.


Enrollment: 80
Study Start Date: September 2009
Estimated Study Completion Date: December 2014
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: controlgroup
Participants in the control group are instructed to live their ordinary life.
Experimental: Group exercise program
The intervention group will exercise two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients. HIFE consists of exercise in functional weight-bearing positions and include lower limb strenght and and balance exercise in standing and walking.
 Other: High-Intensity Functional Exercise Programmes (HIFE)
Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.
Other Name: HIFE-training, strenghttraining

  Eligibility

Ages Eligible for Study:   65 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with first-ever stroke in the age of 65-65 years getting their stroke at least one year ago and living in the community.

Exclusion Criteria:

  • Other illness or disability that have an impact on the activity level and participation in tests beside problems after stroke.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01161329

Locations
Sweden
Uppsala university hospital
Uppsala, Sweden, 751 85
Sponsors and Collaborators
Uppsala University
Uppsala County Council, Sweden
Strokeförbundet
Uppsala University Hospital
Investigators
Principal Investigator: Karin Hellström, PhD, RPT Uppsala University
  More Information

No publications provided

Responsible Party: karin hellstrom, Ph.D. RPT, Senoir lecturer, Uppsala University
ClinicalTrials.gov Identifier: NCT01161329     History of Changes
Other Study ID Numbers: Dnr2009/067, Dnr 2009/067, 468063005
Study First Received: July 12, 2010
Last Updated: January 15, 2013
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Uppsala University:
stroke
physical activity
balance
muscle-strength

Additional relevant MeSH terms:
Stroke
Cerebral Infarction
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on May 21, 2013