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

Phase 1
Completed
Conditions
Stroke
Registration Number
NCT01161329
Lead Sponsor
Uppsala University
Brief Summary

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

Detailed Description

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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
67
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
The Berg Balance Scale (BBS)baseline, after 3, 6 months and after 1 year

Total score on the scale: 0-56 Points. Higher scores indicates better balance.

Short Physical Performance Battery (SPPB)Baseline, after 3, 6 months and after 1 year

Total score on the scale: 0-12 Points. Higher scores indicates better functioning. 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.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Uppsala university hospital

🇸🇪

Uppsala, Sweden

Uppsala university hospital
🇸🇪Uppsala, Sweden

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