Physical Activity and Chronic Acquired Brain Injury

Not Applicable

Completed

• Conditions: Quality of Life; Brain Injuries; Motor Activity
• Interventions: Behavioral: Experimental group

• Registration Number: NCT03162484
• Lead Sponsor: Universidad Politecnica de Madrid

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.

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 Timeline

• Study Start: 2016-09
• Study First Submitted: 2016-10-28
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Study First Submitted QC: 2017-05-19
• Last Update Submitted: 2017-05-19
• Study First Posted: 2017-05-22
• Last Update Posted: 2017-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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.

Exclusion Criteria

• Return to work
• Aphasia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physical activity intervention group	Experimental group	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.

Primary Outcome Measures

Name	Time	Method
Mood change measurement	Change from baseline mood at 18 weeks	Profile of Mood States (POMS) Questionnaire
Quality of life change measurement	Change from baseline quality of life at 18 weeks	Short Form 36 Health Survey
Participation in Physical Activities change measurement	Change from baseline participation at 18 weeks	Global Physical Activity Questionnaire

Secondary Outcome Measures

Name	Time	Method
Months since injury	Baseline	sociodemographic data questionnaire
Depression change measurement	Change from baseline depression at 18 weeks	Beck Depression Inventory
Amount of weekly physical activity	Baseline	sociodemographic data questionnaire