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

NCT02978469 | Unknown DMC

• 1 other identifier: 0082-15-ASF
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

• 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.

Conditions

Cerebral Palsy (CP)

Keywords

Habitual Physical Activity (HPA); Sedentary Behavior;

Outcome Measures

Primary Outcomes (1)

• an ActivPAL3™ (PAL Technologies, Glasgow, UK) tri-axial accelerometer-based activity monitor.

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

  Measuring changes: Base line: time 1 before intervention. time 2: changes immediately after finish intervention. time 3: changes 6 months after time 2.

Secondary Outcomes (7)

• 6minWT

  Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.

• 10MWT

  Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.

• TUG

  Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.

• FMS

  Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.

• ASK

  Measuring changes on time line: Base line: time 1 before intervention. time 2: immediately after finish intervention. time 3: 6 months after time 2.

Study Arms (2)

Life style changing: reducing sedentary behavior

EXPERIMENTAL

Meetings with social worker and physical therapist.

Other: Life style changing: reducing sedentary behavior

Physical exercise group

ACTIVE COMPARATOR

Physical therapy exercise training in group, strengthening and stretching muscles.

Other: Life style changing: reducing sedentary behavior

Interventions

Life style changing: reducing sedentary behavior OTHER

The program includes 23 meetings held once per week (with holiday breaks). Each meeting lasts 90 minutes, consisting of exercise training. the group will meet for information providing and discussion. Participants are guided in the process of creating a focussed individualized activity plan. In the group setting they will experience a variety of activities enabling them to explore activities they prefer: each participant receive three personal consultation meetings. The group will experience sport and recreational activities with persons with physical impairments. Also activities in sport in community facilities.

Also known as: 0082-15-ASF

Life style changing: reducing sedentary behavior; Physical exercise group

Eligibility Criteria

• Age: 5 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Intervention group:
• children, adolescents and young adults age 14-25 yrs
• with bilateral spastic Cerebral Palsy
• at GMFCS level I, II and III
• can speak their native language fluently
• able to follow verbal instructions
• willing to train in a group.
• For ASK: age 5-18yrs.
• children, adolescents and young adults age 5-18yrs
• with bilateral spastic Cerebral Palsy
• at GMFCS level I, II and III
• can speak their native language
• able to follow verbal instructions

You may not qualify if:

• Individual who had orthopedic surgery or tone reduction interventions (e.g. botulinum toxin injections, or have a history of baclofen pump or selective dorsal rhizotomy within 6 months prior to this study
• have exercise induced asthma or cardiac problems.

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

MeSH Terms

Conditions

Cerebral Palsy; Phenylketonurias; Sedentary Behavior

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Amino Acid Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Behavior

Study Officials

• Leonel Copeliovitch, MD

  Human Motion Analysis Laboratory, Assaf Harofe Medical Center Zerifin Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2016
• First Posted: December 1, 2016
• Study Start: May 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2017
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share