Barriers to Physical Activity in People With MS (BarKA-MS)
18 november 2021 uppdaterad av: Viktor von Wyl, University of Zurich
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.
Studieöversikt
Status
Avslutad
Betingelser
Studietyp
Observationell
Inskrivning (Faktisk)
45
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
-
Valens, Schweiz, 7317
- Kliniken Valens
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
A minimum of 30 and maximum of 45 patients will be enrolled in this study.
Patients undergoing an inpatient rehabilitation program at Kliniken Valens.
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Step count (Fitbit)
Tidsram: measured continuously over the course of the study, on average of 7-8 weeks
|
measured continuously over the course of the study, on average of 7-8 weeks
|
|
|
Step count (Accelerometer)
Tidsram: measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)
|
measured continuously during the last week at rehab stay and first week at home (= 2 weeks in total)
|
|
|
International Physical Activity Questionnaire-Short Form (IPAQ-SF)
Tidsram: Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
|
Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
|
|
|
Perceived Barriers to Physical Activity
Tidsram: 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".
|
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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Health status and Health-Related Quality of Life (EQ-5D-5L)
Tidsram: 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)
|
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)
Tidsram: 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)
|
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)
|
|
|
Generalized Self Efficacy Scale (GSE)
Tidsram: 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)
|
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)
Tidsram: 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)
|
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
Tidsram: 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.
|
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)
Tidsram: 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)
|
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)
Tidsram: 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)
|
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)
Tidsram: 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)
|
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)
Tidsram: 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)
|
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
Tidsram: 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:
|
Time Frame: change from T0 (baseline), at week 1 - 8 (1 - 8 week after T0)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Viktor von Wyl, Prof. Dr., University of Zurich
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
- 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.
- 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.
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 januari 2021
Primärt slutförande (Faktisk)
14 november 2021
Avslutad studie (Faktisk)
14 november 2021
Studieregistreringsdatum
Först inskickad
28 januari 2021
Först inskickad som uppfyllde QC-kriterierna
4 februari 2021
Första postat (Faktisk)
10 februari 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
19 november 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
18 november 2021
Senast verifierad
1 november 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 1
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Multipel skleros
-
Centre Hospitalier Universitaire de NīmesAvslutadMonckeberg Medial Calcific SclerosisFrankrike
-
Assistance Publique - Hôpitaux de ParisOkändArteriosclerosis Obliterans | Diabetiska vaskulära sjukdomar | Monckeberg Medial Calcific SclerosisFrankrike
-
City of Hope Medical CenterNational Cancer Institute (NCI)Aktiv, inte rekryterandeKlassiskt Hodgkin lymfom | Lymfocytrikt klassiskt Hodgkin-lymfom | Ann Arbor stadium IB Hodgkin lymfom | Ann Arbor stadium II Hodgkin lymfom | Ann Arbor stadium IIA Hodgkin lymfom | Ann Arbor stadium IIB Hodgkin lymfom | Ann Arbor stadium I Hodgkin lymfom | Ann Arbor Steg I blandad cellularitet Klassiskt... och andra villkorFörenta staterna