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Completed

NCT Number: NCT04746807

Barriers to Physical Activity in People With MS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kliniken Valens

Valens, 7317, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Step count (Fitbit)

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

  2. Step count (Accelerometer)

    Time frame: 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)

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

  4. Perceived Barriers to Physical Activity

    Time frame: 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".

Secondary outcomes

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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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.

  6. MS Walking Scale-12 (MSWS-12)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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?

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Dr. Roman Gonzenbach, Kliniken Valens

Registry information

Official study title

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

Acronym: BarKA-MS

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 10, 2021
Registry last updated
Nov 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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