Exercise Therapy Program on Acquired Brain Injury

Acquired Brain Injury Clinical Trial

Official title:

Effects of a Exercise Therapy Program Based on Sports Towards People With Acquired Brain Injury: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05358470
• Other study ID #: Exercise-acquired brain injury
• Status: Completed
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2024
• Source: Universidade da Coruña
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Randomization process (sequence generation, allocation concealment, and implementation) will be conducted by three different researchers from the team. After signing the informed consent and undergoing initial assessment, participants will be allocated to the experimental group (EG) or the control group (CG). It will be made using a computer-generated number sequence, with a 1:1 allocation ratio, without stratification.

The assessments (T1, T2) will be completed by two physiotherapists specifically trained to carry out the outcomes evaluations who will be blinded to group allocation during the entire study period.

The sample size is estimated to obtain statistically significant improvements through the two primary outcomes: (i) health-related quality of life (Physical Component Summary) and (ii) functional capacity (6-minute walk).

(i)The threshold for detecting changes in health-related quality of life is approximately 5 points (Norman et al. 2003). To detect this difference with a standard deviation (SD) of ±5 points between the groups with a 95% confidence interval and a statistical power of 80% in a two-side approach, it would be needed 16 participants. Considering that it could have 15% losses, the final sample size would be 18 subjects in each group.

(ii) On the other hand, since there are no published data on the 6-minute walk test in adults with ABI, it is considered the clinical difference to be significant in healthy adults (standard deviation of ±44). To detect the difference between groups with a confidence interval of 95% and a statistical power of 80%, the sample should be composed of 12 persons by group. Considering a 15% losses, the final sample size would be 14 participants in each group.

In addition, based on previous studies that carried out a similar intervention in persons with adquired brian injury, the total sample should ranged between 30-35 participants.

Both ethics approval and administrative site approvals have been granted by the local ethics committee (Ethics Committee for Clinical Investigation of Madrid, Spain). Full written informed consent will be obtained from all participants indicating voluntary participation in the study. All informed consent data will be collected and stored by the main researcher. This clinical trial has been performed in accordance with the Helsinki Declaration. Participants' personal data will be de-identified (they will be allocated a identification code generated by a random number sequence, which will be used to deidentify participant information). No data that could identify the participants will be published.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: December 1, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acquired Brain Injury
• Brain Injuries
• Wounds and Injuries

Intervention

Other:
• Exercise therapy and adapted physical activity-based program
Exercise therapy and adapted physical activity program based on racket sports

Locations

Country	Name	City	State
Spain	Second Part Foundation	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Universidade da Coruña

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional capacity: 10 Meter Walk Test	- 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.	Baseline, Change from Baseline at 8th week
Primary	Motor control of the upper limb test: Fugl-Meyer Upper Extremity (FM-UE)	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.	Baseline, Change from Baseline at 8th week
Primary	Mobility Test: Timed Up and Go (TUG)	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".	Baseline, Change from Baseline at 8th week
Primary	Balance Test: Balance Berg Scale (BBS)	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.	Baseline, Change from Baseline at 8th week
Primary	Health-related quality of life Questionnaire: Short Form 36 (SF36) v2	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.	Baseline, Change from Baseline at 8th week
Primary	Functional capacity: 6 Minute Walk Test	- 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.	Baseline, Change from Baseline at 8th week
Secondary	Level of physical activity questionnaire	The global level of physical activity will be evaluated through the Global Physical Activity Questionnaire (GPAC). This tool covers several components of physical activity, such as intensity, duration, and frequency, and it assesses three domains in which physical activity is performed (occupational physical activity, transport-related physical activity, and physical activity during discretionary or leisure time). It is advised that show cards be used when the GPAQ is administered. Show cards should be developed for each of the activity types covered by the GPAQ: vigorous and moderate activity at work, transport activity, vigorous and moderate activity during leisure time, as well as sitting.	Baseline, Change from Baseline at 8th week
Secondary	Sociodemographics questionnaire	Date of birth, gender, injury time of evolution and physical activity habits.	Baseline
Secondary	Anthropometric data - Weight	Weight (in kilograms). Weight and height will be combined to report BMI in kg/m^2)	Baseline
Secondary	Anthropometric data - Height	Height (in meters). Weight and height will be combined to report BMI in kg/m^2)	Baseline