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

Completed

Phase 1 Results

Trial Description

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.

Conditions

Interventions

  • High-Intensity Functional Exercise Programmes (HIFE) Other
    Other Names: HIFE-training, strenght-training; Intervention group
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Physical exercises
    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.
    ARM 2: Kind: Experimental
    Label: Group exercise program
    Description: 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.
    ARM 3: Kind: Experimental
    Label: Intervention group
    Description: Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Physical Activity Scale for the Elderly (PASE) baseline, after 3, 6 months and after 1 year No
Secondary Short Physical Performance Battery (SPPB) Baseline, after 3, 6 months and after 1 year Yes
Primary The Berg Balance Scale (BBS) baseline, after 3, 6 months and after 1 year No

Sponsors