Barriers to Physical Activity in People With MS

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT04746807
• Lead Sponsor: University of Zurich

Brief Summary

Multiple Sclerosis (MS) is a chronic inflammatory disease leading to the demyelination of the central nervous system. Promoting physical activity has gathered attention as an effective means to improve health-related quality of life and to mitigate symptoms such as fatigue and depressive symptoms in individuals suffering from MS. However, persons suffering from MS often experience difficulties in staying active. A comprehensive understanding of barriers to staying physical active for persons with MS in Switzerland is currently lacking. Given the importance of physical activity in the context of MS a detailed understanding of this matter would be key for future research and treatment.

A key challenge when studying physical activity in the context of MS is to obtain objective and accurate measurements that are not prone to reporting bias. While accelerometer-based measurements hold promise in this regard they are not convenient for routine implementation in real-world environments. Initial research has identified consumer-grade wearables such as Fitbits as a promising alternative whereby focusing on the main outcome average step count. Given the rich detail of activity patterns that can be derived from such devices, research has so far underutilized the available information that has the potential to provide more comprehensive insight into this matter.

Objectives: The present project aims to determine the common factors in real-life settings limiting physical activity in persons with MS and the impact of these barriers on physical activity. Further, the present study aims to provide precedence for future research investigating physical activity in MS by examining the quality, reliability, internal consistency, and validity of PA metrics derived from the wide-spread consumer-grade activity tracker Fitbit in comparison to an accelerometer.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-08
• Study First Submitted: 2021-01-28
• Study First Submitted QC: 2021-02-04
• Study First Posted: 2021-02-10
• Status Verified: 2021-11
• Primary Completion: 2021-11-14
• Study Completion: 2021-11-14
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

• aged 18 years or older
• definite diagnosis of relapsing or progressive MS (i.e., confirmed by their physician)
• persons with reduced walking ability but who are still able to walk independently with or without an assistive device (e.g., as expressed by an Expanded Disability Status Scale score between 3-6.5)
• possess a personal computer, mobile phone or a tablet with Bluetooth functionality,
• be willing and able to perform study procedures,
• be able to provide informed consent
• be able to answer the questionnaires in German.

Exclusion Criteria

• serious illnesses that preclude safe participation in physical activity
• inability to follow study procedures
• inability to complete questionnaires in German
• inability to complete baseline questionnaires or activate the Fitbit device will lead to the exclusion of the participant from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
International Physical Activity Questionnaire-Short Form (IPAQ-SF)	Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
Perceived Barriers to Physical Activity	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)	Perceived Barriers to Physical Activity will be assessed by a modified version of the Barriers to Health Promoting Activities for Disabled Persons Scale. The original version of this instrument lists 18 barriers and asks participants to indicate "how much each of these problems \[the barriers\] keeps you from participating in health-promoting activities." This scale has been previously modified to measure barriers to physical activity, instead asking participants to indicate "how much each of these problems keeps you from participating in physical activity and exercise".
Step count (Fitbit)	measured continuously over the course of the study, on average of 7-8 weeks
Step count (Accelerometer)	measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)

Secondary Outcome Measures

Name	Time	Method
Health status and Health-Related Quality of Life (EQ-5D-5L)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
MS Walking Scale-12 (MSWS-12)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
10 Meter Walk Test (10mWT)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
Patient Health Questionnaire depression scale (PHQ-8)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
Timed Up and Go (TUG)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
Valens in-house pain scale	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)	Pain will be assessed using three 11-point scales (0 = no pain at all; 10 = strongest pain I can imagine). Participants will be asked to rate pain intensity at the present moment as well as minimal and maximal pain intensity over the previous week.
Generalized Self Efficacy Scale (GSE)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
6 Minute Walk Test (6MWT)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
Fatigue Scale for Motor and Cognitive Functions (FSMC)	Time Frame: change from T0 (entry to study) at post-treatment (2-4 weeks after T0), change from T0 at 4 weeks follow-up (6-8 weeks after T0)
Weekly diary	Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)	Participants will also be asked to complete a weekly diary. Each week, participants will be prompted to document circumstances in their daily life that either prevented or instead supported engaging in PA in an open-ended questionnaire. More specifically, participants will be asked to answer the following questions: * What kind of goals in terms of PA did you pursue this week?; * What prevented you this week from engaging in physical activities?; * What facilitated this week engaging in physical activities?; * What would have been helpful to increase PA?; * What was your experience with the activity trackers this week?

Trial Locations

Locations (1)

Kliniken Valens; 🇨🇭 Valens, Switzerland