Acquired Brain InjuryNCT05358470
Exercise Therapy Program on Acquired Brain Injury
A study testing Exercise therapy and adapted physical activity-based program in people with Acquired Brain Injury, run by Universidade da Coruña at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acquired Brain Injury
- What is being tested?
- Exercise therapy and adapted physical activity-based program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2023to 1 Dec 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Exercise Therapy Program Based on Sports Towards People With Acquired Brain Injury: a Randomized Controlled Trial
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.
Read the 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.
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.
- Conditions
- Acquired Brain Injury
- Being tested
- Exercise therapy and adapted physical activity-based program
- Keywords
- Exercise therapy, Physical Therapy, Exercise, Sports for persons with disabilities
- Medical subject headings
- Brain Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise therapy and adapted physical activity-based programOther
Exercise therapy and adapted physical activity program based on racket sports
| Study group | Role | What they receive |
|---|---|---|
| Exercise therapy and adapted physical activity-based intervention | Experimental | 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. Receives: Other: Exercise therapy and adapted physical activity-based program |
| Usual care | No intervention | Participants in the CG receive conventional management with general physical activity recommendation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Change from Baseline at 8th week
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.
Measured: Baseline, Change from Baseline at 8th week
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".
Measured: Baseline, Change from Baseline at 8th week
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.
Measured: Baseline, Change from Baseline at 8th week
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.
Measured: Baseline, Change from Baseline at 8th week
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.
Measured: Baseline, Change from Baseline at 8th week
Secondary outcomes (4)
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.
Measured: Baseline, Change from Baseline at 8th week
Sociodemographics questionnaire
Date of birth, gender, injury time of evolution and physical activity habits.
Measured: Baseline
Anthropometric data - Weight
Weight (in kilograms). Weight and height will be combined to report BMI in kg/m^2)
Measured: Baseline
Anthropometric data - Height
Height (in meters). Weight and height will be combined to report BMI in kg/m^2)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start1 Feb 2023
- Primary completion30 Nov 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain InjuryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade da Coruña
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Beatriz Rodríguez-Romero, Universidade da Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05358470
- Sponsor's protocol ID
- Exercise-acquired brain injury
- Status last verified
- Jan 2024
- First submitted
- 21 Mar 2022
- Last updated
- 23 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Exercise Therapy Program Based on Sports Towards People With Acquired Brain Injury: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05358470
- Acronym / sponsor ID
- Exercise-acquired brain injury
- Conditions
- Acquired Brain Injury
- Keywords
- Exercise therapy, Physical Therapy, Exercise, Sports for persons with disabilities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universidade da CoruñaUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 3 May 2022 (actual)
- 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.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise therapy and adapted physical activity-based intervention | Experimental | Other: Exercise therapy and adapted physical activity-based programThe 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. |
| Usual care | No intervention | –Participants in the CG receive conventional management with general physical activity recommendation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Exercise therapy and adapted physical activity-based programExercise therapy and adapted physical activity program based on racket sports | Other | Exercise therapy and adapted physical activity-based intervention |
Primary outcome
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.
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.
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".
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.
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.
4 secondary outcomes
Level of physical activity questionnaire
Time frame: Baseline, Change from Baseline at 8th week
Sociodemographics questionnaire
Time frame: Baseline
Anthropometric data - Weight
Time frame: Baseline
Anthropometric data - Height
Time frame: Baseline
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 23 Jan 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Acquired Brain Injury
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
RecruitingObservational study
Predict Severe Traumatic Brain Injury
Traumatic Brain Injury
RecruitingPhase 4
Early Post-Traumatic Seizures Prevention Trial (E-PTS Trial)
Seizures, Traumatic Brain Injuries
Recruiting
The Coma Family Program (COMA-F): A Resilience Program for Caregivers of Patients With Severe Acute Brain Injury
Caregiver Distress, Emotional Distress
Recruiting
Informational Needs of Caregivers of Patients With Neuromotor Disease in Rehabilitation Hospitalization: Validation Study of the QBI-R/V
Neuro-Degenerative Diseases, Care Givers
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise therapy and adapted physical activity-based program in people with Acquired Brain Injury, run by Universidade da Coruña at 1 site in Spain.
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 4 inclusion and 4 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 23 Jan 2024. 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 Spain. 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 capacity: 10 Meter Walk Test (time frame: Baseline, Change from Baseline at 8th week). The study lists 6 primary outcomes in all. 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 23 Jan 2024.