Exercise and Physical Activity in Adults with Acquired Brain Injury (PA_ABI)

March 24, 2025 updated by: Andrea Gutiérrez Suárez, Universidade da Coruña
Exercise and physical activity in adults with acquired brain injury

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Although emerging approaches have emerged in the design of interventions that promote an orientation towards physical activity scientific evidence on their efficacy in this particular population remains limited. This underscores the need for further research to evaluate the efficacy of these intervention approaches in the context of ABI.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged more than 18 years of age and present a medical diagnosis of acquired brain injury.
  • Have the informed consent completed and signed
  • Present a state that allows following indications for the practice of exercise and physical activity.

Exclusion Criteria:

  • Have medical comorbidities that contraindicate the safe performance of the program (i.e., cardiac or respiratory instability, uncontrolled seizures).
  • Have additional disabling conditions, such as cognitive impairment and/or an inability to communicate with the researcher verbally, in writing, or through an emissary.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental: Exercise and physical activity program and usual care
Exercise and physical activity program and usual care
Behavioral: Exercise
Exercise and physical activity program and usual care
Other: Usual Care
Usual cara and Exercise and PA recommendations
No Intervention: Control: usual care
Only usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life
Time Frame: Baseline an through study completion, an average of 1 year
Euroqol 5d Quality of Life outcome
Baseline an through study completion, an average of 1 year
Physical Actvity
Time Frame: Baseline an through study completion, an average of 1 year
International Physical Actvity Questionnaire
Baseline an through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade da Coruña

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2025

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

March 5, 2025

First Submitted That Met QC Criteria

March 24, 2025

First Posted (Estimated)

March 26, 2025

Study Record Updates

Last Update Posted (Estimated)

March 26, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PA_ABI

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Acquired Brain Injury

Clinical Trials on Exercise

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe