Physical Activity and Chronic Acquired Brain Injury

NCT03162484 | Completed

• 1 other identifier: Universidad Politécnica
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Brain Injuries; Motor Activity; Quality of Life

Outcome Measures

Primary Outcomes (3)

• Mood change measurement

  Profile of Mood States (POMS) Questionnaire

  Change from baseline mood at 18 weeks

• Quality of life change measurement

  Short Form 36 Health Survey

  Change from baseline quality of life at 18 weeks

• Participation in Physical Activities change measurement

  Global Physical Activity Questionnaire

  Change from baseline participation at 18 weeks

Secondary Outcomes (3)

• Depression change measurement

  Change from baseline depression at 18 weeks

• Months since injury

  Baseline

• Amount of weekly physical activity

  Baseline

Study Arms (2)

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.

Behavioral: Experimental group

Control group

NO INTERVENTION

People in control group did not receive any physical activity program.

Interventions

Experimental group BEHAVIORAL

The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.

Physical activity intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Return to work
• Aphasia

Sponsors & Collaborators

• Universidad Politecnica de Madrid: lead

MeSH Terms

Conditions

Brain Injuries; Motor Activity

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavior

Study Officials

• Javier Pérez, PhD

  Universidad Politecnica de Madrid

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: May 22, 2017
• Study Start: September 1, 2016
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 22, 2017

Record last verified: 2017-05