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Physical Activity and Chronic Acquired Brain Injury (PASBI)

Primary Purpose

Brain Injuries, Motor Activity, Quality of Life

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Experimental group
Sponsored by
Universidad Politecnica de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Brain Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Physical activity intervention group

    Control group

    Arm Description

    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.

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

    Outcomes

    Primary Outcome Measures

    Mood change measurement
    Profile of Mood States (POMS) Questionnaire
    Quality of life change measurement
    Short Form 36 Health Survey
    Participation in Physical Activities change measurement
    Global Physical Activity Questionnaire

    Secondary Outcome Measures

    Depression change measurement
    Beck Depression Inventory
    Months since injury
    sociodemographic data questionnaire
    Amount of weekly physical activity
    sociodemographic data questionnaire

    Full Information

    First Posted
    October 28, 2016
    Last Updated
    May 19, 2017
    Sponsor
    Universidad Politecnica de Madrid
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03162484
    Brief Title
    Physical Activity and Chronic Acquired Brain Injury
    Acronym
    PASBI
    Official Title
    Effect of a Physical Activity Group Programme on the Health of People With Chronic Acquired Brain Injury
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2016 (Actual)
    Primary Completion Date
    May 2017 (Actual)
    Study Completion Date
    May 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Politecnica de Madrid

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Brain Injuries, Motor Activity, Quality of Life

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physical activity intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    People in control group did not receive any physical activity program.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Experimental group
    Intervention Description
    The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.
    Primary Outcome Measure Information:
    Title
    Mood change measurement
    Description
    Profile of Mood States (POMS) Questionnaire
    Time Frame
    Change from baseline mood at 18 weeks
    Title
    Quality of life change measurement
    Description
    Short Form 36 Health Survey
    Time Frame
    Change from baseline quality of life at 18 weeks
    Title
    Participation in Physical Activities change measurement
    Description
    Global Physical Activity Questionnaire
    Time Frame
    Change from baseline participation at 18 weeks
    Secondary Outcome Measure Information:
    Title
    Depression change measurement
    Description
    Beck Depression Inventory
    Time Frame
    Change from baseline depression at 18 weeks
    Title
    Months since injury
    Description
    sociodemographic data questionnaire
    Time Frame
    Baseline
    Title
    Amount of weekly physical activity
    Description
    sociodemographic data questionnaire
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Javier Pérez, PhD
    Organizational Affiliation
    Universidad Politecnica de Madrid
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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