4006-776-356 出国就医服务电话

免费获得国外相关药品，最快 1 个工作日回馈药物信息

出境医 / 临床实验 / Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS)

Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS)

Study Description
Brief Summary:
Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Behavioral: Individualized behavioural physical activity intervention Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Actual Study Start Date : July 12, 2019
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : March 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Behavioural Physical Activity (PA) intervention Behavioral: Individualized behavioural physical activity intervention
• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.
No Intervention: Wait list control
Outcome Measures
Primary Outcome Measures :
  1. Godin Leisure Time Exercise Questionnaire (GLTEQ) Score [ Time Frame: baseline to 12 months ]
    change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.


Secondary Outcome Measures :
  1. Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2) [ Time Frame: baseline to 12 months ]
    change in patient-reported disease-related symptoms measured using MSIS-29 v2 scale. MSIS-29 assess the impact of MS on health related quality of life in terms of physical and psychological well-being. The MSIS-29 v2 is a 29 item self-administered questionnaire. 20 items are associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options: 1 "not at all" to 4"extremely". Min score=29, max =116 with a higher value indicating more severely impacted

  2. Multiple Sclerosis Self Efficacy Scale (MSSE) [ Time Frame: baseline to 12 months ]
    change in patient-reported level of confidence regarding components of disease management. The MSSE has 18 items represented by two subscales of Function (9 items) and Control (9 items). Participants rate their confidence from 10-100 where 10 has an anchor of very uncertain, 50 moderately certain, and 100 very certain. A higher score meaning more confident/higher self-efficacy.

  3. Interviews and Exit surveys [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group ]
    experience of participants and interventionists

  4. Intervention Description [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group) ]
    a description of interventionist contact time with participant and frequency, method and types of services provided


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinically definite MS (diagnosed by a neurologist)
  • patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
  • GLTEQ<24 (not active enough for health benefits)

Exclusion Criteria:

  • medical instability (PAR-Q moderate-high risk of exercise-related harm)
  • persons unable to provide consent
  • persons under the age of 18 years old
Contacts and Locations

Locations
Layout table for location information
Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7N 2Z4
Sponsors and Collaborators
University of Saskatchewan
Saskatchewan Health Research Foundation (SHRF)
Saskatchewan Centre for Patient-Oriented Research
Tracking Information
First Submitted Date  ICMJE July 10, 2019
First Posted Date  ICMJE July 19, 2019
Last Update Posted Date March 26, 2020
Actual Study Start Date  ICMJE July 12, 2019
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 16, 2019) 		Godin Leisure Time Exercise Questionnaire (GLTEQ) Score [ Time Frame: baseline to 12 months ]
change in physical activity level. The GLTEQ is a 4-item self-administered questionnaire with the first three questions seeking information on the number of times one engages in mild, moderate and strenuous activity in bouts of at least 15 min duration in a typical week. Total leisure activity score is then calculated based on number of bouts at each intensity multiplied by 3, 5, and 9 metabolic equivalents and summed. A higher score means more physically active.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • Multiple Sclerosis Impact Scale version 2 (MSIS-29 v2) [ Time Frame: baseline to 12 months ]
    change in patient-reported disease-related symptoms measured using MSIS-29 v2 scale. MSIS-29 assess the impact of MS on health related quality of life in terms of physical and psychological well-being. The MSIS-29 v2 is a 29 item self-administered questionnaire. 20 items are associated with a physical scale and 9 items with a psychological scale. Items ask about the impact of MS on day-to-day life in the past two weeks. All items have 4 response options: 1 "not at all" to 4"extremely". Min score=29, max =116 with a higher value indicating more severely impacted
  • Multiple Sclerosis Self Efficacy Scale (MSSE) [ Time Frame: baseline to 12 months ]
    change in patient-reported level of confidence regarding components of disease management. The MSSE has 18 items represented by two subscales of Function (9 items) and Control (9 items). Participants rate their confidence from 10-100 where 10 has an anchor of very uncertain, 50 moderately certain, and 100 very certain. A higher score meaning more confident/higher self-efficacy.
  • Interviews and Exit surveys [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control) group ]
    experience of participants and interventionists
  • Intervention Description [ Time Frame: after intervention (at 12 month point for intervention group and 18 month for wait-list control group) ]
    a description of interventionist contact time with participant and frequency, method and types of services provided
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis
Official Title  ICMJE Individualized Physiotherapy and Activity Coaching for Multiple Sclerosis (IPAC-MS): A Randomised Controlled Trial
Brief Summary Multiple Sclerosis (MS) is a chronic neurological disease that places a high burden on patients, families and society. Physical activity in MS is associated with improved fitness, symptoms, and function, fewer relapses, and fewer brain lesions on MRI. Saskatchewan has one of the highest rates of MS worldwide, and a recent survey estimated approximately 80% of persons living with MS are not sufficiently active for health benefits. Individuals living with MS recognize the importance of physical activity, but often indicate a lack support, including limited access to professionals knowledgeable about both MS and physical activity. There is a need to identify effective interventions for improving activity levels safely and appropriately. Behaviour change strategies target specific behaviours involved in increasing and maintaining physical activity. The primary objective of this project is to determine if individualized behaviour change strategies delivered by neurophysiotherapists increases physical activity in MS. Participants will be randomly assigned into two groups. The intervention group will receive individualized behaviour change strategies delivered through the support of neurophysiotherapists for 12 months. The wait-list control group will receive usual care for 12 months, and then be offered the intervention for a 6-month period at the end of the study period. The long-term goal of this research is to help decrease the burden of MS by identifying new opportunities for increasing physical activity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Behavioral: Individualized behavioural physical activity intervention
• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.
Study Arms  ICMJE
  • Experimental: Behavioural Physical Activity (PA) intervention
    Intervention: Behavioral: Individualized behavioural physical activity intervention
  • No Intervention: Wait list control
Publications * Goulding FL, Evans CD, Knox KB, Lim HJ, Levin MC, Donkers SJ. Individualised behaviour change strategies for physical activity in multiple sclerosis (IPAC-MS): protocol for a randomised controlled trial. Trials. 2019 Dec 2;20(1):664. doi: 10.1186/s13063-019-3768-7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 16, 2019) 		120
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinically definite MS (diagnosed by a neurologist)
  • patient determined disease steps (PDDS) less than or equal to 6 (i.e. not wheel-chair bound)
  • GLTEQ<24 (not active enough for health benefits)

Exclusion Criteria:

  • medical instability (PAR-Q moderate-high risk of exercise-related harm)
  • persons unable to provide consent
  • persons under the age of 18 years old
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04027114
Other Study ID Numbers  ICMJE Bio-1019
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sarah Donkers, University of Saskatchewan
Study Sponsor  ICMJE University of Saskatchewan
Collaborators  ICMJE
  • Saskatchewan Health Research Foundation (SHRF)
  • Saskatchewan Centre for Patient-Oriented Research
Investigators  ICMJE Not Provided
PRS Account University of Saskatchewan
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

治疗医院

新药特效药

前沿医讯