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Completed

NCT Number: NCT03162484

Physical Activity and 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.

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Key information

Conditions

Brain Injuries Behavior Brain Diseases Central Nervous System Diseases Craniocerebral Trauma Motor Activity Nervous System Diseases Quality of Life Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental group

Behavioral

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

Primary outcomes

  1. Mood change measurement

    Time frame: Change from baseline mood at 18 weeks

    Profile of Mood States (POMS) Questionnaire

  2. Quality of life change measurement

    Time frame: Change from baseline quality of life at 18 weeks

    Short Form 36 Health Survey

  3. Participation in Physical Activities change measurement

    Time frame: Change from baseline participation at 18 weeks

    Global Physical Activity Questionnaire

Secondary outcomes

  1. Depression change measurement

    Time frame: Change from baseline depression at 18 weeks

    Beck Depression Inventory

  2. Months since injury

    Time frame: Baseline

    sociodemographic data questionnaire

  3. Amount of weekly physical activity

    Time frame: Baseline

    sociodemographic data questionnaire

Sponsors and collaborators

Lead sponsor

Universidad Politecnica de Madrid

Other

Registry information

Official study title

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

Acronym: PASBI

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 22, 2017
Registry last updated
May 22, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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