Overview

This trial is active, not recruiting.

Condition stroke
Treatment high-intensity functional exercise programmes (hife)
Phase phase 1
Sponsor Uppsala University
Collaborator Uppsala County Council, Sweden
Start date September 2009
End date July 2012
Trial size 80 participants
Trial identifier NCT01161329, 468063005, Dnr 2009/067, Dnr2009/067

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(No Intervention)
Participants in the control group are instructed to live their ordinary life.
(Experimental)
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.
high-intensity functional exercise programmes (hife) HIFE-training, strenghttraining
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.

Primary Outcomes

Measure
Physical Activity Scale for the Elderly (PASE)
time frame: baseline, after 3, 6 months and after 1 year

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 65 years up to 85 years old.

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.

Additional Information

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
Principal investigator Karin Hellström, PhD, RPT
Trial information was received from ClinicalTrials.gov and was last updated in January 2013.
Information provided to ClinicalTrials.gov by Uppsala University.