Clinical Trial: ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: ATOMIC (Active Teens With MultIple sClerosis) Teens: A Feasibility Study

Brief Summary: Taking part in recommended levels of physical activity in youth with MS may have an important and positive impact on disease symptoms, long-term disability and health outcomes. Unfortunately, youth with MS are highly inactive. In order to address this issue, the investigators have developed an MS-specific mobile application for teens called Active Teens with Multiple Sclerosis (ATOMIC). In this research the investigators will evaluate the feasibility of using the ATOMIC program in youth with MS. The results of this pilot study will provide the data necessary to ensure the ATOMIC program aligns with the needs of youth with MS.

Detailed Summary:
Sponsor: The Hospital for Sick Children

Current Primary Outcome:

• Semi-structured Interviews [ Time Frame: 30 minutes ]
  Interviews will be used to elicit the perceptions and preferences of the participants surrounding the use and method of delivery of the PA coaching and program content (e.g. phone, text messaging, posts to app); the usefulness, relevance, and applicability of the ATOMIC program content; as well as facilitators and barriers to use of the program. Semi-structured interviews will be conducted at baseline, six weeks, and post-intervention.
• Physical Activity Level (MVPA) [ Time Frame: 12-weeks ]
  Accelerometry is a valid objective PA measure that will be used to determine MVPA. Children will be asked to wear the accelerometer daily for 7 days, and the investigators will analyze cases that have four or more days of data with ≥ 10 hours of wear time per day. The investigators will process the accelerometer data and use validated cutoffs to determine sedentary, light, and MVPA.
• Peak Oxygen Consumption (VO2Peak) - Braked Cycle Ergometer [ Time Frame: Baseline and end of 12-weeks ]
  Cardiorespiratory Fitness (Aerobic Capacity) will be determined from an 8 to 10 minute ramp test according to the Godfrey protocol conducted on an electronically braked cycle ergometer (Lode Examiner, Lode BV, Groningen, The Netherlands). After a three-minute warm-up of unloaded cycling, the workload will be increased in increments according to the participants height by either 10, 15, or 20 watts/min for heights of <125 cm, 125-150 cm, or >150 cm, respectively. Subjects will be fitted with a facemask and breath-by-breath measures will be collected and analyzed for oxygen uptake (VO2).
  
  

  Original Primary Outcome: Same as current
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: The Hospital for Sick Children
  

  Dates:
  Date Received: January 3, 2017
  Date Started: June 2017
  Date Completion: May 2018
  Last Updated: April 28, 2017
  Last Verified: April 2017