Brain InjuriesPASBINCT03162484
Physical Activity and Chronic Acquired Brain Injury
A study testing Experimental group in people with Brain Injuries and Motor Activity, run by Universidad Politecnica de Madrid.
Trial summary
Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Injuries, Motor Activity, Quality of Life
- What is being tested?
- Experimental group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to May 2017
- 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
- Individuals with mild to moderate chronic acquired brain injury from any cause.
- Being over 18 years of age.
- Being practice two or more sessions per week.
- Ability to understand and complete questionnaires in Spanish.
- Voluntary participation in the study.
- Signed informed consent by the patient and/or their primary caregiver.
Who cannot join
- Return to work
- Aphasia
About this study
Official title: Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury
Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).
The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.
Read the detailed description
This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.
- Conditions
- Brain Injuries, Motor Activity, Quality of Life
- Being tested
- Experimental group
- 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.
Experimental groupBehavioural
The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention group | Experimental | The intervention consisted in doing physical activities two to four times per week, each session last 60 minutes. The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.
Each session starts with a warm up. The main part of the session is divided into two sections. The first section includes different exercises to improve balance, mobility and coordination. The second section is comprised of communicative and cooperative games. The session finishes with a cool-down. Receives: Behavioral: Experimental group |
| Control group | No intervention | People in control group did not receive any physical activity program. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mood change measurement
Profile of Mood States (POMS) Questionnaire
Measured: Change from baseline mood at 18 weeks
Quality of life change measurement
Short Form 36 Health Survey
Measured: Change from baseline quality of life at 18 weeks
Participation in Physical Activities change measurement
Global Physical Activity Questionnaire
Measured: Change from baseline participation at 18 weeks
Secondary outcomes (3)
Depression change measurement
Beck Depression Inventory
Measured: Change from baseline depression at 18 weeks
Months since injury
sociodemographic data questionnaire
Measured: Baseline
Amount of weekly physical activity
sociodemographic data questionnaire
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2017
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Politecnica de Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marta Pérez Rodriguez, Universidad Politecnica de Madrid
- Investigators
- Javier Pérez, PhD, Study director, Universidad Politecnica de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03162484
- Sponsor's protocol ID
- Universidad Politécnica
- Acronym
- PASBI
- Status last verified
- May 2017
- First submitted
- 28 Oct 2016
- Last updated
- 22 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury
- ClinicalTrials.gov ID
- NCT03162484
- Acronym / sponsor ID
- PASBI / Universidad Politécnica
- Conditions
- Brain Injuries, Motor Activity, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universidad Politecnica de MadridUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 22 May 2017 (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.
Most individuals who have survived an acquired brain injury (ABI) present consequences affecting the sensorimotor, cognitive, affective or behavioural components. The conditions can vary from mild to extreme. The consequences of an ABI may have a considerable impact on their functioning, and secondary conditions like depression or sedentary behaviours, so they suffer changes in their Health-Related Quality of Life (HRQoL).
The purpose of this project is to determine the effect of a physical activity group program on HRQoL. As well as to identify factors that facilitate or act as a barrier to practice physical activity.
Detailed description
This study is a quasi experimental pre-post test with nonequivalent group design. There were two groups: 30 subjects with chronic ABI took part in a physical activity group program designed by a Sport Club in Madrid, Spain; and 30 subjects with chronic ABI which did not practice physical activity.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention group | Experimental | Behavioral: Experimental groupThe intervention consisted in doing physical activities two to four times per week, each session last 60 minutes. The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool. Each session starts with a warm up. The main part of the session is divided into two sections. The first section includes different exercises to improve balance, mobility and coordination. The second section is comprised of communicative and cooperative games. The session finishes with a cool-down. |
| Control group | No intervention | –People in control group did not receive any physical activity program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Individuals with mild to moderate chronic acquired brain injury from any cause.
- Being over 18 years of age.
- Being practice two or more sessions per week.
- Ability to understand and complete questionnaires in Spanish.
- Voluntary participation in the study.
Key exclusion criteria (2 listed)
- Return to work
- Aphasia
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 |
|---|---|---|
| Experimental groupThe program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool. | Behavioural | Physical activity intervention group |
Primary outcome
Mood change measurement
Time frame: Change from baseline mood at 18 weeks
Profile of Mood States (POMS) Questionnaire
Quality of life change measurement
Time frame: Change from baseline quality of life at 18 weeks
Short Form 36 Health Survey
Participation in Physical Activities change measurement
Time frame: Change from baseline participation at 18 weeks
Global Physical Activity Questionnaire
3 secondary outcomes
Depression change measurement
Time frame: Change from baseline depression at 18 weeks
Months since injury
Time frame: Baseline
Amount of weekly physical activity
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 22 May 2017.
- Individual participant dataSharing planned: Undecided
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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.
Javier Pérez, PhD study director
Universidad Politecnica de Madrid
Questions about this trial
What is this clinical trial studying?
A study testing Experimental group in people with Brain Injuries and Motor Activity, run by Universidad Politecnica de Madrid.
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 6 inclusion and 2 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 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Mood change measurement (time frame: Change from baseline mood at 18 weeks). The study lists 3 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 22 May 2017.