Barriers to Physical Activity in People With MS

Multiple Sclerosis Clinical Trial

— BarKA-MS  

Official title:

Barriers to Physical Activity in People With MS (Barrieren für körperliche Aktivität Bei MS-Betroffenen - BarKA-MS) - A Longitudinal Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04746807
• Other study ID #: 1
• Status: Completed
• Start date: January 8, 2021
• Est. completion date: November 14, 2021

Study information

• Verified date: November 2021
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: November 14, 2021
• Est. primary completion date: November 14, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
Switzerland	Kliniken Valens	Valens

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Dr. Roman Gonzenbach, Kliniken Valens

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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;(9):CD009956. doi: 10.1002/14651858.CD009956.pub2. Review. — View Citation

Motl RW, McAuley E, Snook EM. Physical activity and multiple sclerosis: a meta-analysis. Mult Scler. 2005 Aug;11(4):459-63. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Step count (Fitbit)		measured continuously over the course of the study, on average of 7-8 weeks
Primary	Step count (Accelerometer)		measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)
Primary	International Physical Activity Questionnaire-Short Form (IPAQ-SF)		Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
Primary	Perceived Barriers to Physical Activity	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".	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Valens in-house pain scale	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.	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Weekly diary	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?	Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)