Effects of a Exercise Therapy Program Based on Sports Towards People With Acquired Brain Injury: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidade da Coruña
- Enrollment
- 23
- Locations
- 1
- Primary Endpoint
- Motor control of the upper limb test: Fugl-Meyer Upper Extremity (FM-UE)
Study Overview
Brief Summary
In this study, the physical and psychosocial effects of a exercise therapy and adapted physical activity program based on racket sports for ambulant people with acquired brain injury will be investigated.
Detailed Description
The proposed protocol study is a two-arm, randomized, assessor-blinded trial with two parallel groups.
The study population consists of ambulant people aged more than 18 years with a confirmed diagnosis of acquire brain injury at subacute or chronic stages. Participants who agree to participate in the study will be assigned to experimental group (EG) (exercise therapy and adapted physical activity program) or control group (CG) (usual care) after being screened and randomized according to the inclusion criteria.
A physiotherapist will perform the evaluation process, including physical performance and biopsychosocial aspects. Information on functioning and disability will be collected through the ICF components, including Contextual Factors such as "Personal" and "Environmental", and Functioning domains such as "Body Functions and Structures" (b-components), "Activities & Participation" (d-components) as well as "Quality of Life components" . The main outcome measures of the study are: (i)"health-related quality of life" through the questionnaire Short Form 36; (ii) "functional capacity", attending to aspects of mobility and endurance on walking which will be measured through two tests: the 6 Minutes Walk Test and the 10 Meter Walk Test; (iii) motor control of the upper limb, through the Fugl-Meyer Upper Extremity test; (iv) "mobility" which will be measured with Timed Up and Go; (v) and "balance", through the Balance Berg Scale. As secondary outcome measures of the study, the level of physical activity through the Global Physical Activity Questionnaire will be measured. Moreover, demographic and anthropometric characteristics will be also considered.
Outcome measures will be assessed at baseline (T1) and immediately after 8 weeks of program (T2),
Participants in EG a progressive program based on a therapeutic exercise and adapted physical activity program based on racket sports, will be practiced for 60 minutes a day, 2 days a week for 8 weeks. In CG, participants will receive conventional management with general physical activity recommendation. The intervention will be guided and supervised by a physiotherapist and delivered in groups of 5 participants.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Persons with a medical diagnosis of acquired brain injury in subacute or chronic stages.
- •To be aged >18 years at study entry
- •To have an independent gait without the need of technical aids: a score of 3, 4 or 5 from the Functional Ambulation Categories (FAC) walking test.
- •Be able to understand simple instructions from the program protocols as well as perform baseline and post-intervention assessments.
Exclusion Criteria
- •Not have a completed and signed informed consent form.
- •Non-attendance and/or non-collaboration to 70% of the program sessions.
- •To have medical co-morbidities that contraindicate physical exercise safely (e.g. cardiac or respiratory instability, uncontrolled seizures)
- •Non-collaboration during the pre- and post-tests of the program.
Arms & Interventions
Exercise therapy and adapted physical activity-based intervention
The intervention in the experimental group (EG) consists of a exercise therapy and adapted physical activity program based on racket sports. The immediate EG will receive sixteen, twice a week, one-hour sessions of group-based, racket sports specific fundamental movement skills training. All sessions will be guided and supervised by a physiotherapist and delivered in groups of 5 participants to promote exchange and conviviality and to optimize the rates of participation and compliance.
Intervention: Exercise therapy and adapted physical activity-based program (Other)
Usual care
Participants in the CG receive conventional management with general physical activity recommendation.
Outcomes
Primary Outcomes
Motor control of the upper limb test: Fugl-Meyer Upper Extremity (FM-UE)
Time Frame: Baseline, Change from Baseline at 8th week
FM-UE is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning, balance, sensation and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment.
Balance Test: Balance Berg Scale (BBS)
Time Frame: Baseline, Change from Baseline at 8th week
This scale is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It does not include the assessment of gait. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function.
Functional capacity: 10 Meter Walk Test
Time Frame: Baseline, Change from Baseline at 8th week
- 10 Meter Walk Test: The 10MWT is a performance measure used to assess walking speed in meters per second over a short distance. It can be employed to determine functional mobility, gait, and vestibular function.
Mobility Test: Timed Up and Go (TUG)
Time Frame: Baseline, Change from Baseline at 8th week
This test is a general physical performance test used to assess mobility, balance and locomotor performance in elderly people with balance disturbances. More specifically, it assesses the ability to perform sequential motor tasks relative to walking and turning. This test is rated on a scale of second measurement, considering less than 10 second as "normal function" and more than 30 seconds as "severely abnormal function".
Health-related quality of life Questionnaire: Short Form 36 (SF36) v2
Time Frame: Baseline, Change from Baseline at 8th week
This questionnaire evaluate general health status in eight domains: physical function, role physical, bodily pain, general health, vitality, social function, role emotional and mental health; which are also reduced to Physical and Mental Component Summary scores. Values above or below 50 (the normative score from the general population) are interpreted as better or worse than the reference population, respectively.
Functional capacity: 6 Minute Walk Test
Time Frame: Baseline, Change from Baseline at 8th week
- 6 Minutes Walk Test: The 6MWT is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. The measurement is considered by meters, so the more meters the user is able to get, the more distance and "normal functioning" will register.
Secondary Outcomes
- Level of physical activity questionnaire(Baseline, Change from Baseline at 8th week)
- Anthropometric data - Height(Baseline)
- Sociodemographics questionnaire(Baseline)
- Anthropometric data - Weight(Baseline)
Investigators
Beatriz Rodríguez-Romero
Lecturer at Department of Physiotherapy, Medicine and Biomedical Sciences. Universidade da Coruña
Universidade da Coruña