Clinical trial NCT04746807: Barriers to Physical Activity in People With MS
Official title: Barriers to Physical Activity in People With MS (Barrieren für körperliche Aktivität Bei MS-Betroffenen - BarKA-MS) - A Longitudinal Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis
physical acitivity
digital mobility measurements
real-life assessments
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: Dr. Roman Gonzenbach, Kliniken Valens
First posted: 2021-02-10
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A minimum of 30 and maximum of 45 patients will be enrolled in this study. Patients undergoing an inpatient rehabilitation program at Kliniken Valens.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Step count (Fitbit)
timeFrame: measured continuously over the course of the study, on average of 7-8 weeks
measure: Step count (Accelerometer)
timeFrame: measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)
measure: International Physical Activity Questionnaire-Short Form (IPAQ-SF)
timeFrame: Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
measure: Perceived Barriers to Physical Activity
timeFrame: 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)
Secondary outcomes:
measure: Health status and Health-Related Quality of Life (EQ-5D-5L)
timeFrame: 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)
measure: Patient Health Questionnaire depression scale (PHQ-8)
timeFrame: 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)
measure: Generalized Self Efficacy Scale (GSE)
timeFrame: 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)
measure: Fatigue Scale for Motor and Cognitive Functions (FSMC)
timeFrame: 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)
measure: Valens in-house pain scale
timeFrame: 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)
measure: MS Walking Scale-12 (MSWS-12)
timeFrame: 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)
measure: Timed Up and Go (TUG)
timeFrame: 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)
measure: 10 Meter Walk Test (10mWT)
timeFrame: 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)
measure: 6 Minute Walk Test (6MWT)
timeFrame: 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)
measure: Weekly diary
timeFrame: Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
Other outcomes:
Locations:
city: Valens
country: Switzerland
facility: Kliniken Valens
Study officials:
affiliation: University of Zurich
name: Viktor von Wyl, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chiu C, Bishop M, Pionke JJ, Strauser D, Santens RL. Barriers to the Accessibility and Continuity of Health-Care Services in People with Multiple Sclerosis: A Literature Review. Int J MS Care. 2017 Nov-Dec;19(6):313-321. doi: 10.7224/1537-2073.2016-016.
citation: Block VJ, Bove R, Zhao C, Garcha P, Graves J, Romeo AR, Green AJ, Allen DD, Hollenbach JA, Olgin JE, Marcus GM, Pletcher MJ, Cree BAC, Gelfand JM. Association of Continuous Assessment of Step Count by Remote Monitoring With Disability Progression Among Adults With Multiple Sclerosis. JAMA Netw Open. 2019 Mar 1;2(3):e190570. doi: 10.1001/jamanetworkopen.2019.0570.
citation: Heine M, van de Port I, Rietberg MB, van Wegen EE, Kwakkel G. Exercise therapy for fatigue in multiple sclerosis. Cochrane Database Syst Rev. 2015 Sep 11;2015(9):CD009956. doi: 10.1002/14651858.CD009956.pub2.
citation: Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. doi: 10.1191/1352458505ms1188oa.