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| ID | Type | Description | Link |
|---|---|---|---|
| Dnr 2009/067 | Other Identifier | Regional ethical review board of Uppsala | |
| 468063005 | Other Identifier | Stroke-National Association, Sweden |
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| Name | Class |
|---|---|
| Uppsala County Council, Sweden | OTHER_GOV |
| Uppsala University Hospital | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | Participants in the control group are instructed to live their ordinary life. | |
| Intervention group | Experimental | Exercising two times/week according to the High-Intensity Functional Exercise Program (HIFE) in groups of 5-7 patients in combination with motivational discussions. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-Intensity Functional Exercise Programmes (HIFE) | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Berg Balance Scale (BBS) | Total score on the scale: 0-56 Points. Higher scores indicates better balance. | baseline, after 3, 6 months and after 1 year |
| 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. | Baseline, after 3, 6 months and after 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karin Hellström, PhD, RPT | Uppsala University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uppsala university hospital | Uppsala | 751 85 | Sweden |
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Of the 195 eligible participants 124 were ineligible and 4 declined participation..
A total of 195 individuals where screened for eligibility consecutively between October 2009 to April 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Controlgroup | Instructed to live their ordinary life. |
| FG001 | Intervention Group | High-Intensity Functional Exercise Program (HIFE) in combination with motivational group discussions two times a week. . |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Controlgroup | Ordinary life. |
| BG001 | Intervention Group | High Intensity Functional Exercise Program |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Berg Balance Scale (BBS) | Total score on the scale: 0-56 Points. Higher scores indicates better balance. | Posted | Mean | Standard Deviation | units on a scale | baseline, after 3, 6 months and after 1 year |
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Under 15 months
At each assessment where participants asked about adverse events
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Controlgroup | Ordinary life. |
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The early termination of the study produced limited Power and increased the risk of type 1-errors.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Karin Hellström | UppsalaU | +46184714762 | karin.hellstrom@neuro.uu.se |
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| ID | Term |
|---|---|
| D020521 | Stroke |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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|
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| BG002 |
| Total |
Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Months since stroke | Median | Inter-Quartile Range | months |
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| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, after 3, 6 months and after 1 year |
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| 0 |
| 33 |
| 0 |
| 33 |
| EG001 | Intervention Group | High Intensity Functional Exercise Program | 0 | 34 | 0 | 34 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001519 | Behavior |
| Mean SPPB change from baseline to 15 months |
|