Cerebrovascular DisordersNCT01674452
Home-based Exercises for Patients With Stroke
A study testing home-based group (HBG) and supervised exercise group (SEG) in people with Cerebrovascular Disorders and Brain Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cerebrovascular Disorders, Brain Infarction, Brain Ischemia
- What is being tested?
- home-based group (HBG) and supervised exercise group (SEG)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2010to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- severe cognitive impairment
- Commodity that preclude them from undergoing training and assessment
- Neurological disease other than stroke
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Department of Physical therapy, Medicine School of University of São Paulo
São Paulo, São Paulo, 05360-000
About this study
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.
Read the 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.
- Conditions
- Cerebrovascular Disorders, Brain Infarction, Brain Ischemia, Stroke
- Being tested
- home-based group (HBG), supervised exercise group (SEG)
- Keywords
- Stroke, Exercise and Physical Fitness
- Medical subject headings
- Cerebrovascular Disorders, Brain Infarction, Brain Ischemia, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based group (HBG)Behavioural
Also called Home-based exercise supported by an illustrated manual
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.
supervised exercise group (SEG)Behavioural
Also called Conventional supervised exercise training
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).
| Study group | Role | What they receive |
|---|---|---|
| home-based group | Experimental | Not described Receives: Behavioral: home-based group (HBG) |
| supervised exercise group | Active comparator | Not described Receives: Behavioral: supervised exercise group (SEG) |
| control | No intervention | Control group:no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2012 (estimated)
- Study startJan 2010
- Primary completionFeb 2011
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cerebrovascular DisordersStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Elisa Pimentel Piemonte, University of Sao Paulo General Hospital
- Investigators
- Maria Elisa P Piemonte, Study director, Department of Physical therapy,School of Medicine, University of Sao PauloTatiana P Oliveira, Principal investigator, Department of Physical therapy, School of Medicine, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01674452
- Sponsor's protocol ID
- USPNEC003
- Status last verified
- Aug 2012
- First submitted
- 13 Aug 2012
- Last updated
- 28 Aug 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based Exercises for Patients With Stroke
- ClinicalTrials.gov ID
- NCT01674452
- Acronym / sponsor ID
- USPNEC003
- Conditions
- Cerebrovascular Disorders, Brain Infarction, Brain Ischemia, Stroke
- Keywords
- Stroke, Exercise and Physical Fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 28 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| home-based group | Experimental | Behavioral: home-based group (HBG) |
| supervised exercise group | Active comparator | Behavioral: supervised exercise group (SEG) |
| control | No intervention | –Control group:no intervention |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- severe cognitive impairment
- Commodity that preclude them from undergoing training and assessment
- Neurological disease other than stroke
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based group (HBG)Also: Home-based exercise supported by an illustrated manualParticipants 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. | Behavioural | home-based group |
| supervised exercise group (SEG)Also: Conventional supervised exercise trainingPatients 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). | Behavioural | supervised exercise group |
Primary outcome
Functional Independence Measure
Time frame: 6 months
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.
1 secondary outcome
motor performance, Fugl-Meyer scale
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Elisa P Piemonte study director
Department of Physical therapy,School of Medicine, University of Sao Paulo
Tatiana P Oliveira principal investigator
Department of Physical therapy, School of Medicine, University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based group (HBG) and supervised exercise group (SEG) in people with Cerebrovascular Disorders and Brain Infarction, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Independence Measure (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2012.