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

• ClinicalTrials.gov Identifier: NCT01161329
• Recruitment Status: Completed
• First Posted: July 13, 2010
• Results First Posted: July 11, 2016
• Last Update Posted: July 11, 2016
• Sponsor: Uppsala University
• Collaborators: Uppsala County Council, Sweden; Uppsala University Hospital
• Information provided by (Responsible Party): karin hellstrom, Uppsala University

Study Description

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

Condition or disease	Intervention/treatment	Phase
Stroke	Other: High-Intensity Functional Exercise Programmes (HIFE)	Phase 1

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 67 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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
• Study Start Date: September 2009
• Actual Primary Completion Date: July 2012
• Actual Study Completion Date: February 2016

Arms and Interventions

Arm	Intervention/treatment
No Intervention: Control group; Participants in the control group are instructed to live their ordinary life.
Experimental: 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.	Other: 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.; Other Names: HIFE-training, strenght-training; Intervention group

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 85 Years (Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Sweden

Uppsala university hospital

Uppsala, Sweden, 751 85

Sponsors and Collaborators

Uppsala University

Uppsala County Council, Sweden

Uppsala University Hospital

Investigators

• Principal Investigator: Karin Hellström, PhD, RPT; Uppsala University

More Information

• Responsible Party: karin hellstrom, Ass Prof. RPT, Senoir lecturer, Uppsala University
• ClinicalTrials.gov Identifier: NCT01161329
• Other Study ID Numbers: Dnr2009/067; Dnr 2009/067 ( Other Identifier: Regional ethical review board of Uppsala ); 468063005 ( Other Identifier: Stroke-National Association, Sweden )
• First Posted: July 13, 2010
• Results First Posted: July 11, 2016
• Last Update Posted: July 11, 2016
• Last Verified: May 2016

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

Keywords provided by karin hellstrom, Uppsala University:

stroke; physical activity; balance; muscle-strength

Additional relevant MeSH terms:

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases