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

NCT ID: NCT01161329

Last Updated: 2016-07-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2016-02-29

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.

Conditions

Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Control group

Participants in the control group are instructed to live their ordinary life.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions.

Group Type: EXPERIMENTAL

High-Intensity Functional Exercise Programmes (HIFE)

Intervention Type: OTHER

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.

Interventions

High-Intensity Functional Exercise Programmes (HIFE)

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.

Intervention Type: OTHER

Other Intervention Names

HIFE-training, strenght-training; Intervention group

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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uppsala County Council, Sweden

OTHER_GOV

Sponsor Role: collaborator

Uppsala University Hospital

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: lead

Responsible Party

karin hellstrom

Ass Prof. RPT, Senoir lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Karin Hellström, PhD, RPT

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

Uppsala university hospital

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2009/067

Identifier Type: OTHER

Identifier Source: secondary_id

468063005

Identifier Type: OTHER

Identifier Source: secondary_id

Dnr2009/067

Identifier Type: -

Identifier Source: org_study_id