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Home-based Exercises for Patients With Stroke

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Maria Elisa Pimentel Piemonte, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01674452
First received: August 13, 2012
Last updated: August 24, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention
Cerebrovascular Disorders
Brain Infarction
Brain Ischemia
Stroke
Behavioral: home-based group (HBG)
Behavioral: supervised exercise group (SEG)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Home-based Exercises for Patients With Stroke

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Functional Independence Measure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 90
Study Start Date: January 2010
Study Completion Date: July 2012
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: home-based group Behavioral: home-based group (HBG)
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.
Other Name: Home-based exercise supported by an illustrated manual
Active Comparator: supervised exercise group Behavioral: supervised exercise group (SEG)
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).
Other Name: Conventional supervised exercise training
No Intervention: control
Control group:no intervention

Detailed Description:
  1. 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.
  2. 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.
  3. 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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01674452

Locations
Brazil
Department of Physical therapy, Medicine School of University of São Paulo
São Paulo, Brazil, 05360-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Study Director: Maria Elisa P Piemonte Department of Physical therapy,School of Medicine, University of Sao Paulo
Principal Investigator: Tatiana P Oliveira Department of Physical therapy, School of Medicine, University of Sao Paulo
  More Information

No publications provided

Responsible Party: Maria Elisa Pimentel Piemonte, PT; PhD, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01674452     History of Changes
Other Study ID Numbers: USPNEC003
Study First Received: August 13, 2012
Last Updated: August 24, 2012
Health Authority: Brazil: Ethics Committee
Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Stroke
Exercise and Physical Fitness

Additional relevant MeSH terms:
Brain Infarction
Brain Ischemia
Cerebral Infarction
Cerebrovascular Disorders
Infarction
Stroke
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Ischemia
Necrosis
Nervous System Diseases
Pathologic Processes
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014