Clinical trial NCT01161329: Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Stroke
Keywords: stroke
physical activity
balance
muscle-strength
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Uppsala County Council, Sweden
name: Uppsala University Hospital
First posted: 2010-07-13
Enrollment: 67
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The Berg Balance Scale (BBS)
timeFrame: baseline, after 3, 6 months and after 1 year
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline, after 3, 6 months and after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Uppsala
country: Sweden
facility: Uppsala university hospital
Study officials:
affiliation: Uppsala University
name: Karin Hellström, PhD, RPT
role: PRINCIPAL_INVESTIGATOR
References: