Physical Activity and Chronic Acquired Brain Injury (PASBI)

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Brain Injuries; Motor Activity
• Intervention / Treatment: Behavioral: Experimental group

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 Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Physical activity intervention 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.	Behavioral: Experimental group; The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.
No Intervention: Control group; People in control group did not receive any physical activity program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universidad Politecnica de Madrid
• Investigators: Study Director: Javier Pérez, PhD, Universidad Politécnica de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: May 19, 2017
• First Posted (Actual): May 22, 2017

Study Record Updates

• Last Update Posted (Actual): May 22, 2017
• Last Update Submitted That Met QC Criteria: May 19, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Wounds and Injuries
• Other Study ID Numbers: Universidad Politécnica

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED