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AzTrials

Multiple SclerosisBarKA-MSNCT04746807

Barriers to Physical Activity in People With MS

An observational study of Multiple Sclerosis, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
How many people
45 participants
Where
1 siteSwitzerland
Study dates
8 Jan 2021to 14 Nov 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Kliniken Valens

    Valens, 7317

Other trials in Switzerland

About this study

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

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.

Keywords
Multiple Sclerosis, physical acitivity, digital mobility measurements, real-life assessments
Medical subject headings
Multiple Sclerosis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Step count (Fitbit)

    Measured: measured continuously over the course of the study, on average of 7-8 weeks

  2. Step count (Accelerometer)

    Measured: measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)

  3. International Physical Activity Questionnaire-Short Form (IPAQ-SF)

    Measured: Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)

  4. 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".

    Measured: 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 (10)

  1. Health status and Health-Related Quality of Life (EQ-5D-5L)

    Measured: 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)

  2. Patient Health Questionnaire depression scale (PHQ-8)

    Measured: 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)

  3. Generalized Self Efficacy Scale (GSE)

    Measured: 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)

  4. Fatigue Scale for Motor and Cognitive Functions (FSMC)

    Measured: 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)

  5. 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.

    Measured: 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. MS Walking Scale-12 (MSWS-12)

    Measured: 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)

  7. Timed Up and Go (TUG)

    Measured: 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)

  8. 10 Meter Walk Test (10mWT)

    Measured: 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)

  9. 6 Minute Walk Test (6MWT)

    Measured: 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. 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?

    Measured: Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Feb 2021
  2. Study start8 Jan 2021
  3. Primary completion14 Nov 2021
  4. Study completion14 Nov 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04746807
Sponsor's protocol ID
1
Acronym
BarKA-MS
Status last verified
Nov 2021
First submitted
28 Jan 2021
Last updated
19 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 29270089

  • 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.

    PubMed 30874777

  • 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.

    PubMed 26358158

  • 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.

    PubMed 16042230

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Step count (Fitbit) (time frame: measured continuously over the course of the study, on average of 7-8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04746807, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021; AzTrials last refreshed its copy on 3 Nov 2026.

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