Clinical Trial: Go For It: to Improve Levels of Daily Physical Activity and to Reduce the Sedentary Life Style of Adolescents With CP

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Promoting Active Healthy Lifestyle of Adolescents With Brain Damage Due to Traumatic Brain Injury and Cerebral Palsy

Brief Summary:

Long hours of daily sitting and lack of Physical Activity (PA) are risk factors for morbidity and mortality.

People with movement disabilities, including adolescents with Cerebral Palsy (CP) tend to lead a sedentary life styl and have have poor physical fitness. Adolescents with CP where found to be inactive most of the day thus, they are in greater risk of disease than the general population. In addition, over the years, people with disabilities experience physical and functional deterioration. Reducing sedentary behavior and increasing daily activity can reduce health risk factors among the adolescents with CP, reduce secondary impairments and preserve function.

Interventions that included exercise alone has not resulted in physical activity and participating in a structured training did not continue after cessation intervention.

The objectives of this study are to establish effective programs aiming to promote an active life style among adolescents and young adults with CP and to evaluate there outcomes.

Specific objectives- Stage 1- Identifying barriers and facilitators for reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP. As well as, identifying mediators, needs and preferences for reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP.

Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and increasing physical activity among adolescents.

Stage 3- translating and developing questioners for the study.


  • Detailed Summary:

    Stage 1 focus group- Identifying barriers and facilitators for reducing sedentary behaviors and increasing physical activity as well as, identifying mediators, needs and preferences for reducing sedentary behaviors and increasing physical activity.

    Stage 2- Based on stage 1- Establishing an intervention for reducing sedentary behaviors and increasing physical activity among adolescents. The intervention group will receive behavior-modification in group. The control group will get physical exercises.Stage 3- translating and developing questioners for the study.

    • Translating the ASK-Performance and the ASK-Capability questionnaires to Hebrew and validating the Hebrew translation.
    • Developing a self-efficacy perception questioner for increasing physical activity and reducing and sedentary behavior.
    • Translating to Hebrew, adjusting and validating an activity diary.

    Stage 4- evaluating the effectiveness of the proposed intervention program on reducing sedentary behaviors and increasing physical activity among adolescents and young adults with CP. The outcome measures will measure change from base line after intervention and 4-6 months after intervention finished.

    All partners of this project will obtain approval for experiments on human subjects from their local committees. Each subject (or parents/guardians for the participation of minor subjects) will be able to sign an informed voluntary consent form, consistent with the Helsinki Declaration, after reading a detailed explanation and having an oral Q/A session with the investigator.

    Recruitment: Prospective focused direct m
    Sponsor: Assaf-Harofeh Medical Center

    Current Primary Outcome: an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor. [ Time Frame: Measuring changes: Base line: time 1 before intervention. time 2: changes immediately after finish intervention. time 3: changes 6 months after time 2. ]

    tri-axial accelerometer-based activity monitor. ActivePal accelerometer, is currently considered a reference method for discriminating sitting, standing, and ambulation.


    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    • 6minWT [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2. ]
      6 min walk test (6minWT): This test measures the self-paced distance in meters walked in 6 minutes on a flat, firm surface. This test assesses the sub-maximal level of functional capacity where most activities of daily living are performed and therefore reflects the effort required for daily physical activities.
    • 10MWT [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2. ]
      10 meter walk test (10MWT): This self-paced test measures gait speed, important for safe community mobility (e.g., crossing streets in response to signals). The 10MWT is measured by the time required to walk 10 m. It is a short and convenient test that can be applied to any subject able to ambulate that distance. A variation is the time to walk 10 m as fast as possible.
    • TUG [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2. ]
      Timed Up-and-Go (TUG): This test measures mobility for those able to walk on their own (assistive device permitted). The test includes standing up from a chair, walking 3 m, turning 180°, walking back to the chair and sitting down. The test is measured by the total time to complete the task.
    • FMS [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2. ]
      Functional Mobility Scale (FMS): The FMS uses three distances (5, 50 and 500m) which represent typical distances walked by children at home, at school, and in the wider community. For each distance, a rating of 1 to 6 was assigned, depending on the amount of assistance required for mobility. The rating is performed according to child/parent report of what the child does and is not by clinical observation.
    • ASK [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2. ]
      The Activities Scale for Kids is a child self-report measure of physical disability. It is designed for children five to 15 years of age who are experiencing limitations in physical activity due to musculoskeletal disorders.
    • PEDI-CAT [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention, 4 months after starting intervention. ]
      The PEDI-CAT measures abilities in the three functional domains of Daily Activities, Mobility and Social/Cognitive.
    • Self efficiency questionnaire [ Time Frame: Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. 4 months after starting intervention. ]
      Physical activity and sedentary behavior self efficiency questionnaire. include 17 facets 4 choices of agreements with statements.


    Original Secondary Outcome: Same as current

    Information By: Assaf-Harofeh Medical Center

    Dates:
    Date Received: November 17, 2016
    Date Started: May 2015
    Date Completion: November 2017
    Last Updated: December 4, 2016
    Last Verified: December 2016