NCT06895226

Brief Summary

Exercise and physical activity in adults with acquired brain injury

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2025

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 26, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

April 1, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2025

Completed
Last Updated

March 26, 2025

Status Verified

March 1, 2025

Enrollment Period

7 months

First QC Date

March 5, 2025

Last Update Submit

March 24, 2025

Conditions

Keywords

Acquired brain injuryphysical activityintervention

Outcome Measures

Primary Outcomes (2)

  • Health-related Quality of Life

    Euroqol 5d Quality of Life outcome

    Baseline an through study completion, an average of 1 year

  • Physical Actvity

    International Physical Actvity Questionnaire

    Baseline an through study completion, an average of 1 year

Study Arms (2)

Experimental: Exercise and physical activity program and usual care

EXPERIMENTAL

Exercise and physical activity program and usual care

Behavioral: ExerciseOther: Usual Care

Control: usual care

NO INTERVENTION

Only usual care

Interventions

ExerciseBEHAVIORAL

Exercise and physical activity program and usual care

Experimental: Exercise and physical activity program and usual care

Usual cara and Exercise and PA recommendations

Experimental: Exercise and physical activity program and usual care

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain InjuriesMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Andrea Gutierrez, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

March 5, 2025

First Posted

March 26, 2025

Study Start

April 1, 2025

Primary Completion

November 1, 2025

Study Completion

November 1, 2025

Last Updated

March 26, 2025

Record last verified: 2025-03