Home-based Exercises for Patients With Stroke
Primary Purpose
Cerebrovascular Disorders, Brain Infarction, Brain Ischemia
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
home-based group (HBG)
supervised exercise group (SEG)
Sponsored by
About this trial
This is an interventional treatment trial for Cerebrovascular Disorders focused on measuring Stroke, Exercise and Physical Fitness
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of stroke, confirmed by clinical and radiological evidence
- Ability to understand and follow commands
- willing and able to regularly attend a supervised exercise program
Exclusion Criteria:
- severe cognitive impairment
- Commodity that preclude them from undergoing training and assessment
- Neurological disease other than stroke
Sites / Locations
- Department of Physical therapy, Medicine School of University of São Paulo
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
home-based group
supervised exercise group
control
Arm Description
Control group:no intervention
Outcomes
Primary Outcome Measures
Functional Independence Measure
Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.
Secondary Outcome Measures
motor performance, Fugl-Meyer scale
The Fugl-Meyer physical performance scale assesses five dimensions of impairment, including three aspects of motor control, such as the amplitude of joint movement, pain, sensitivity, motor impairment of the upper and lower extremities and balance. The data are scored in an ordinal scale of 3 (0=no performance; 2=complete performance) applied to each item7. The total motor score is equal to the classification of the upper limb (UL) plus the lower limb (LL), corresponding to 100 total scores (UL=66, LL=34). The total FM score, including the other items, corresponds to 226 scores in the final sum.
Full Information
NCT ID
NCT01674452
First Posted
August 13, 2012
Last Updated
August 24, 2012
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01674452
Brief Title
Home-based Exercises for Patients With Stroke
Official Title
Home-based Exercises for Patients With Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is the development and the implementation of a new protocol about home-based exercises, supported by an illustrated manual, for the treatment of individuals with stroke.
The hypothesis is that this group of patients who are going to carry out the training of this study protocol are going to show improvement in measured parameters (functionality and physical performance), which allows this protocol to be improved and published as a proposal of physiotherapeutic treatment.
Detailed Description
Program Development: 27 exercises were selected, based on the most frequent motor alterations present in hemiparesis. Three modes were created for each exercise: assisted active, active and resisted active executions. Besides explanatory text, there were illustrative photos for all exercises and their modes.
Program Execution: All groups were submitted to a motor evaluation utilizing the Fugl-Meyer Assessment (FMA) and functional evaluation utilizing the Functional independence measure (FIM). After assessment, for the patients of the home-based exercise group (HBG) a group of home exercises was selected for each patient; these exercises were explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when any necessary correction was made. The next steps stipulated by the manual were taken, providing the patients with more complex exercises according to their progress. The patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions two times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).The control group (CG) was assessed but reluctant or unable to regularly attend a supervised exercise program. The groups were reassessed after six months.
Program assessment: The Fugl-Meyer Assessment score and the Functional independence measure score, measured at baseline and after six months, were compared between the groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cerebrovascular Disorders, Brain Infarction, Brain Ischemia, Stroke
Keywords
Stroke, Exercise and Physical Fitness
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
home-based group
Arm Type
Experimental
Arm Title
supervised exercise group
Arm Type
Active Comparator
Arm Title
control
Arm Type
No Intervention
Arm Description
Control group:no intervention
Intervention Type
Behavioral
Intervention Name(s)
home-based group (HBG)
Other Intervention Name(s)
Home-based exercise supported by an illustrated manual
Intervention Description
Participants in the home-based group (HBG) were advised to exercise, a minimum of 4 times per week, but they were encouraged to exercise a total of 5-7 days per week. After individual assessment, a group of home-exercise selected of the manual was explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when necessary corrections were made and the next step stipulated by manual was taken, according to the patient's progress.
Intervention Type
Behavioral
Intervention Name(s)
supervised exercise group (SEG)
Other Intervention Name(s)
Conventional supervised exercise training
Intervention Description
Patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions 2 times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).
Primary Outcome Measure Information:
Title
Functional Independence Measure
Description
Functional Independence Measure (FIM) it is an 18-item ordinal scale with seven levels ranging from 1 (total dependence) to 7 (total independence).FIM can be subdivided into a 13-item motor subscale (eating, grooming, bathing, dressing upper body, dressing lower body, personal hygiene, bladder control, bowel control, transfer to tub/shower, walk or wheelchair, stairs) and 5-item cognitive subscale (comprehension, expression, social interaction, problem solving, memory).The motor and cognitive sub-scales scores range from 13 to 91(motor-FIM) and from 5 to 35 (cognitive-FIM). The maximum total score is 126.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
motor performance, Fugl-Meyer scale
Description
The Fugl-Meyer physical performance scale assesses five dimensions of impairment, including three aspects of motor control, such as the amplitude of joint movement, pain, sensitivity, motor impairment of the upper and lower extremities and balance. The data are scored in an ordinal scale of 3 (0=no performance; 2=complete performance) applied to each item7. The total motor score is equal to the classification of the upper limb (UL) plus the lower limb (LL), corresponding to 100 total scores (UL=66, LL=34). The total FM score, including the other items, corresponds to 226 scores in the final sum.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of stroke, confirmed by clinical and radiological evidence
Ability to understand and follow commands
willing and able to regularly attend a supervised exercise program
Exclusion Criteria:
severe cognitive impairment
Commodity that preclude them from undergoing training and assessment
Neurological disease other than stroke
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Elisa P Piemonte
Organizational Affiliation
Department of Physical therapy,School of Medicine, University of Sao Paulo
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Tatiana P Oliveira
Organizational Affiliation
Department of Physical therapy, School of Medicine, University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical therapy, Medicine School of University of São Paulo
City
São Paulo
ZIP/Postal Code
05360-000
Country
Brazil
12. IPD Sharing Statement
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Home-based Exercises for Patients With Stroke
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