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Phase 1 N=67 Randomized Single-blind Treatment

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

Stroke

Enrolled (actual)
67
Serious AEs
0.0%
Results posted
Jul 2016
Primary outcome: Primary: The Berg Balance Scale (BBS) — -0.06; 4.1; 0.8; 2.3 units on a scale — p=0.001

Study Design & Population

Study type
Interventional
Phase
Phase 1
Interventions
High-Intensity Functional Exercise Programmes (HIFE) (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Uppsala University
Primary completion
Jul 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
The Berg Balance Scale (BBS)
-0.06; 4.1; 0.8; 2.3; -0.6; 1.3 0.001 sig
PRIMARY
Short Physical Performance Battery (SPPB)
0.15; 1.0; 0.4; 0.9; 0.7; 1.3 0.09

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

Eligibility 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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01161329). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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