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

Primary Purpose

Stroke

Status
Completed
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
High-Intensity Functional Exercise Programmes (HIFE)
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring stroke, physical activity, balance, muscle-strength

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Uppsala university hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Intervention group

Arm Description

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

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

Outcomes

Primary Outcome Measures

The Berg Balance Scale (BBS)
Total score on the scale: 0-56 Points. Higher scores indicates better balance.
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.

Secondary Outcome Measures

Full Information

First Posted
July 12, 2010
Last Updated
May 31, 2016
Sponsor
Uppsala University
Collaborators
Uppsala County Council, Sweden, Uppsala University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01161329
Brief Title
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

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uppsala University
Collaborators
Uppsala County Council, Sweden, Uppsala University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
stroke, physical activity, balance, muscle-strength

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants in the control group are instructed to live their ordinary life.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions.
Intervention Type
Other
Intervention Name(s)
High-Intensity Functional Exercise Programmes (HIFE)
Other Intervention Name(s)
HIFE-training, strenght-training, Intervention group
Intervention 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.
Primary Outcome Measure Information:
Title
The Berg Balance Scale (BBS)
Description
Total score on the scale: 0-56 Points. Higher scores indicates better balance.
Time Frame
baseline, after 3, 6 months and after 1 year
Title
Short Physical Performance Battery (SPPB)
Description
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.
Time Frame
Baseline, after 3, 6 months and after 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karin Hellström, PhD, RPT
Organizational Affiliation
Uppsala University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uppsala university hospital
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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