Physical Activity and Chronic Acquired Brain Injury

Quality of Life Clinical Trial

— PASBI  

Official title:

Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03162484
• Other study ID #: Universidad Politécnica
• Status: Completed
• Phase: N/A
• First received: October 28, 2016
• Last updated: May 19, 2017
• Start date: September 2016
• Est. completion date: May 2017

Study information

• Verified date: May 2017
• Source: Universidad Politecnica de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2017
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Motor Activity
• Quality of Life
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Politecnica de Madrid

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mood change measurement	Profile of Mood States (POMS) Questionnaire	Change from baseline mood at 18 weeks
Primary	Quality of life change measurement	Short Form 36 Health Survey	Change from baseline quality of life at 18 weeks
Primary	Participation in Physical Activities change measurement	Global Physical Activity Questionnaire	Change from baseline participation at 18 weeks
Secondary	Depression change measurement	Beck Depression Inventory	Change from baseline depression at 18 weeks
Secondary	Months since injury	sociodemographic data questionnaire	Baseline
Secondary	Amount of weekly physical activity	sociodemographic data questionnaire	Baseline