Text Size

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

July 12, 2010
January 15, 2013
September 2009
July 2012   (final data collection date for primary outcome measure)
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.
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 leasure activities items over a one week period and are administrated in-person.
Complete list of historical versions of study NCT01161329 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach
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

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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Stroke
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
  • 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.
    Intervention: Other: High-Intensity Functional Exercise Programmes (HIFE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2014
July 2012   (final data collection date for primary outcome measure)

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.
Both
65 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01161329
Dnr2009/067, Dnr 2009/067, 468063005
Yes
karin hellstrom, Uppsala University
Uppsala University
  • Uppsala County Council, Sweden
  • Strokeförbundet
  • Uppsala University Hospital
Principal Investigator: Karin Hellström, PhD, RPT Uppsala University
Uppsala University
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP