Stroke
Conditions
Keywords
stroke, physical activity, balance, muscle-strength
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.
Interventions
OTHERHigh-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.
Sponsors
Uppsala County Council, Sweden
Uppsala University Hospital
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Berg Balance Scale (BBS) | baseline, after 3, 6 months and after 1 year | Total score on the scale: 0-56 Points. Higher scores indicates better balance. |
| Short Physical Performance Battery (SPPB) | 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. |
Countries
Sweden
Participant flow
Recruitment details
A total of 195 individuals where screened for eligibility consecutively between October 2009 to April 2011.
Pre-assignment details
Of the 195 eligible participants 124 were ineligible and 4 declined participation..
Participants by arm
| Arm | Count |
|---|---|
| Controlgroup Ordinary life. | 33 |
| Intervention Group High Intensity Functional Exercise Program | 34 |
| Total | 67 |
Baseline characteristics
| Characteristic | Controlgroup | Intervention Group | Total |
|---|---|---|---|
| Age, Continuous | 73.7 years STANDARD_DEVIATION 5.3 | 72.6 years STANDARD_DEVIATION 5.5 | 73.1 years STANDARD_DEVIATION 5.4 |
| Months since stroke | 13 months | 13 months | 13 months |
| Region of Enrollment Sweden | 33 participants | 34 participants | 67 participants |
| Sex: Female, Male Female | 9 Participants | 7 Participants | 16 Participants |
| Sex: Female, Male Male | 24 Participants | 27 Participants | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 33 | 0 / 34 |
| serious Total, serious adverse events | 0 / 33 | 0 / 34 |
Outcome results
Primary
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.
Time frame: Baseline, after 3, 6 months and after 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Controlgroup | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 3 months | 0.15 units on a scale | Standard Deviation 1.1 |
| Controlgroup | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 6 monnths | 0.4 units on a scale | Standard Deviation 1.8 |
| Controlgroup | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 15 months | 0.7 units on a scale | Standard Deviation 2.4 |
| Intervention Group | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 3 months | 1.0 units on a scale | Standard Deviation 2.8 |
| Intervention Group | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 6 monnths | 0.9 units on a scale | Standard Deviation 2.7 |
| Intervention Group | Short Physical Performance Battery (SPPB) | Mean SPPB change from baseline to 15 months | 1.3 units on a scale | Standard Deviation 2.4 |
p-value: 0.09Wilcoxon (Mann-Whitney)
Primary
The Berg Balance Scale (BBS)
Total score on the scale: 0-56 Points. Higher scores indicates better balance.
Time frame: baseline, after 3, 6 months and after 1 year
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Controlgroup | The Berg Balance Scale (BBS) | BBS change from baseline to 15 months | -0.6 units on a scale | Standard Deviation 3.4 |
| Controlgroup | The Berg Balance Scale (BBS) | BBS change from baseline to 3 months | -0.06 units on a scale | Standard Deviation 2.8 |
| Controlgroup | The Berg Balance Scale (BBS) | BBS change from baseline to 6 months | 0.8 units on a scale | Standard Deviation 7.9 |
| Intervention Group | The Berg Balance Scale (BBS) | BBS change from baseline to 6 months | 2.3 units on a scale | Standard Deviation 9.5 |
| Intervention Group | The Berg Balance Scale (BBS) | BBS change from baseline to 3 months | 4.1 units on a scale | Standard Deviation 9.1 |
| Intervention Group | The Berg Balance Scale (BBS) | BBS change from baseline to 15 months | 1.3 units on a scale | Standard Deviation 5.4 |
Comparison: Intention-to-treat analysis was performed to assess the effects on the outcome measures. Between-group differences for all outcome measures were analyzed using Mann-Whitney U-test.p-value: 0.001Wilcoxon (Mann-Whitney)