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

Stroke Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01161329
• Other study ID #: Dnr2009/067
• Secondary ID: Dnr 2009/0674680
• Status: Active, not recruiting
• Phase: Phase 1
• First received: July 12, 2010
• Last updated: January 15, 2013
• Start date: September 2009
• Est. completion date: December 2014

Study information

• Verified date: January 2013
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2014
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Stroke

Intervention

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.

Locations

Country	Name	City	State
Sweden	Uppsala university hospital	Uppsala

Sponsors (4)

Lead Sponsor	Collaborator
Uppsala University	Strokeförbundet, Uppsala County Council, Sweden, Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Physical Activity Scale for the Elderly (PASE)	The instrument is comprised of self-reported occupational, household and leisure activities items over a one week period and are administrated in-person.	baseline, after 3, 6 months and after 1 year	No
Secondary	Short Physical Performance Battery (SPPB)	The 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	Yes