Physical Activity and Chronic Acquired Brain Injury

NCT ID: NCT03162484

Last Updated: 2017-05-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2017-05-31

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.

Conditions

Brain Injuries; Motor Activity; Quality of Life

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Experimental group

Intervention Type: BEHAVIORAL

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

Control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Experimental group

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Politecnica de Madrid

OTHER

Sponsor Role: lead

Responsible Party

Marta Pérez Rodriguez

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Javier Pérez, PhD

Role: STUDY_DIRECTOR

Universidad Politecnica de Madrid

Other Identifiers

Universidad Politécnica

Identifier Type: -

Identifier Source: org_study_id