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

Study Overview
=================
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: level of physical activity, motor function and balance depression and health-related quality of life body mass index (BMI), metabolic risk profile, inflammation status 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.

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

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Other: High-Intensity Functional Exercise Programmes (HIFE)


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br>Participants in the control group are instructed to live their ordinary life. | |
| Experimental: Intervention group<br>Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions. | Other: High-Intensity Functional Exercise Programmes (HIFE)<br>* 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.<br>* Other names: Intervention group;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Berg Balance Scale (BBS) | Total score on the scale: 0-56 Points. Higher scores indicates better balance. | baseline, after 3, 6 months and after 1 year | 
| Short Physical Performance Battery (SPPB) | 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. | Baseline, after 3, 6 months and after 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, physical activity, balance, muscle-strength