Physical activity and quality of life in people with multiple sclerosis in Tyrol, Austria
| ISRCTN | ISRCTN45742963 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45742963 |
| Secondary identifying numbers | 1288/2020 |
- Submission date
- 07/12/2020
- Registration date
- 27/01/2021
- Last edited
- 04/08/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Background and study aims:
Multiple sclerosis (MS) is a disease of the human nervous system. Approximately 2.5 million people suffer from this disease worldwide. Increasing mobility impairment is a key symptom in people with MS. That leads to reduced social participation and quality of life in people concerned. These limitations appear early in the course of the disease and are often seen together with deconditioning and muscle weakness. Both factors are related with a reduction in physical activity in the MS population. People with MS are less physically active compared to adults from the general population and are at a higher risk of suffering from diseases like heart diseases. Physical activity and physical exercise can help people with MS to manage symptoms and optimize their quality of life. Therefore, it is very important to increase the amount of physical activity in the MS population and motivate them to spend more time exercising and being more physically active. The aim of this study is hence to learn about the amount of physical activity, quality of life and other influencing factors in the MS population in Tyrol. A second aim of the study is to develop a German language questionnaire, which assesses physical activity barriers and motivators in people with MS. The in-depth knowledge gained from our study will then help us developing targeted interventions for enhancing physical activity in people with MS.
Who can participate?
Adults aged 18 years and over who were diagnosed with MS, are fluent in German and live in the Austrian region of Tyrol.
What does the study involve?
This study will be conducted in four clinics in the Austrian region of Tyrol and consists of three study phases. We plan to include a total of 550 people with MS in this study. In Phase 1, 30 participants will be interviewed about aspects of their physical activity. Results from that will be utilized for developing a questionnaire on the barriers and motivators for physical activity in people with MS. In Phases 2 and 3, 460 people with MS with mild to moderate disability will be asked to complete 7 questionnaires to assess their amount, barriers and motivators for physical activity and quality of life. Another 60 people with MS with severe disability will be interviewed about the comprehension of a physical activity questionnaire previously translated into German. In addition, these people will be asked to complete 5 of the above-mentioned questionnaires. An Actigraph GT3X-BT will be used to measure their physical activity.
What are the possible benefits and risks of participating?
There will be no immediate direct benefits to those taking part. We however expect an indirect benefit to people with MS over the longer term. This is due to our increased knowledge about the activity behaviour, barriers and motivational factors to physical activity the MS population, which enables us to develop new treatment strategies. Hence, we hope that our study findings will positively influence the rehabilitation process in people with MS. There will be no risks to the participants of this study.
Where is the study run from?
The study is run by the Karl Landsteiner Institute for Interdisciplinary Research at the Rehabilitation Center Muenster, Austria and will take place at four clinics in the Austrian region of Tyrol.
When is the study starting and how long is it expected to run for?
December 2020 to June 2026
Who is funding the study?
The present study is funded by Sanofi Genzyme GmbH (Austria)
Who is the main contact?
Dr. Christian Brenneis
Christian.Brenneis@reha-muenster.at
Contact information
Scientific
Gröben 700
Münster
6232
Austria
 ORCID ID |
0000-0001-5699-9077 |
|---|---|
| Phone | +43 5337200046205 |
| Barbara.Seebacher@reha-muenster.at |
Public
Gröben 700
Münster
6232
Austria
| ORCID ID |
0009-0006-6077-4966 |
|---|---|
| Phone | +43 5337200046204 |
| Andreas.Wanitschek@reha-muenster.at |
Public
Gröben 700
Muenster
6232
Austria
| ORCID ID |
0000-0002-6291-9659 |
|---|---|
| Phone | +43 5337200046336 |
| Rainer.Ehling@reha-muenster.at |
Study information
| Study design | Multicenter observational cross-sectional trial |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cross sectional study |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Activity behaviour and health related quality of life in people with multiple sclerosis in Tyrol, Austria: A cross-sectional study |
| Study acronym | PAMS |
| Study objectives | 1. The level of physical activity in people with multiple sclerosis in Tyrol does not meet the recommended values 2. There is a moderate positive correlation between the levels of physical activity and health-related quality of life in people with multiple sclerosis in Tyrol 3. There is a significant influence of disease-specific factors and self-efficacy on the physical activity behaviour in people with multiple sclerosis in Tyrol 4. Barriers and facilitating factors to physical activity can be identified in people with multiple sclerosis in Tyrol |
| Ethics approval(s) | Approved 30/11/2020, Ethics review committee Medical University of Innsbruck Austria (Innrain 43, A-6020 Innsbruck, Austria; +43 (0)50 504-25444; ethikkommission@i-med.ac.at), ref: 1288/2020 |
| Health condition(s) or problem(s) studied | Observation of the activity behaviour and quality of life in people with multiple sclerosis in Tyrol |
| Intervention | The development of the BaFa-PAMS questionnaire consists of several study phases which are interconnected. The qualitative interviews are necessary to define the construct of barriers and facilitators to physical activity in people with MS. This is followed by the development of an item pool where items will be created based on the literature research and the results from the qualitative interviews. For initial validation of the item pool, the remaining questionnaires and actigraph measures are necessary to test for external validity. Currently, there is no validated German-language questionnaire which is why the translation of the PARA-Sci interview questionnaire is required. Currently the barriers and facilitators to physical activity for people with severe MS are not known, so it is important that they are included in the development study. Study phase 1 People with MS meeting the inclusion criteria will be invited by the principal investigator to participate in an interview during their inpatient rehabilitation at the Rehabilitation Center Muenster/ Karl Landsteiner Institute for Interdisciplinary Research at the Rehabilitation Center Muenster. The duration of the interview will be approximately 30 min, and for each study participant, the study duration will be 1 day Study phase 2 Participants with mild to moderate disability (Expanded Disability Status Scale (EDSS) score of 0 - 6.5): Participants will be asked to complete 7 questionnaires. Completion of the 7 questionnaires will need approximately 60 min and for each study participant, the study duration will be 1 day Participants with severe disability (EDSS score of >6.5): People with MS meeting the inclusion criteria will be invited to participate in the study by the principal investigator of the respective study center. Participants will be asked to complete 5 questionnaires, take part in 1 interview and wear an actigraph. Completion of the 5 questionnaires will need approximately 45 min and the duration of the interview will be approximately 45 min. Participants will wear an actigraph for a period of 7 days. For each study participant, the study duration will be 8 days Study phase 3 Participants with mild to moderate disability (EDSS score of 0 - 6.5): People with MS meeting the inclusion criteria will be invited to participate in the study by the principal investigator of the respective study center. Participants will be asked to complete 6 questionnaires once. In addition, they will be asked to complete 1 questionnaire twice, within a period of 14 days. The duration for the participants to complete the 7 questionnaires (re-test included) will be approximately 70 min and for each study participant, the study duration will be 14 days. Participants with severe disability (EDSS score of >6.5): Participants who are meeting the inclusion criteria are asked to join the study by the principal investigator of the respective study center. Participants are going to complete 5 questionnaires, 1 interview and they are going to wear an actigraph. One of the 5 questionnaires is going to have a re-test 14 days after the initial testing. The duration for the participants to complete the 5 questionnaires (re-test included) will be approximately 55 min. The duration for the participants to complete 1 interview will be approximately 45 min. Participants are going to wear the actigraph for 7 days and will be included in the study for the duration of 21 days |
| Intervention type | Other |
| Primary outcome measure | 1. Physical Activity measured by the International Physical Activity Questionnaire (IPAQ), Godin Leisure Time Exercise Questionnaire (GLTEQ) at baseline 2. Physical Activity measured by the Physical Activity Recall Assessment for People with Spinal Cord Injury (PARA-SCI) over 3 days 3. Physical Activity measured by the Actigraph GT3X-BT (ActiGraph) for 7 days 4. Health-related quality of life is measured by the Multiple Sclerosis International Quality of Life questionnaire (MusiQol) at baseline 5. Disease-specific factors are collected from the patient records at baseline |
| Secondary outcome measures | 1. Fatigue is measured by the Würzburger Erschöpfungsinventar (WEIMUS) at baseline 2. Depression is measured by the Hospital Anxiety and Depression Scale (HADS-D) at baseline 3. Self-efficacy is measured by the Unidimensional Self-Efficacy Scale for MS (USE-MS-G) at baseline 4. Mobility is measured by the Multiple Sclerosis Walking Scale-12 (MSWS-12) at baseline |
| Overall study start date | 01/01/2019 |
| Completion date | 30/06/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 550 |
| Key inclusion criteria | 1. Diagnosed with multiple sclerosis according to revised McDonald criteria (Thompson et al., 2018), independent of disease phenotype or ethnicity 2. Age ≥18 years 3. Principal residence in Tyrol 4. Excellent knowledge of the German language 5. EDSS-Score from 0 to 9.0 (Kurtzke 1983) |
| Key exclusion criteria | 1. Recent relapse from MS (within 90 days prior to the study start) 2. Pregnancy 3. Comorbidity (malignant disease, dementia, other neurological or psychiatric diseases) |
| Date of first enrolment | 01/02/2021 |
| Date of final enrolment | 16/06/2026 |
Locations
Countries of recruitment
- Austria
Study participating centres
Muenster
6232
Austria
Innsbruck
6020
Austria
Zirl
6170
Austria
Kufstein
6330
Austria
Sponsor information
Research organisation
Gröben 700
Muenster
6232
Austria
| Phone | +43 5337200046326 |
|---|---|
| christian.brenneis@reha-muenster.at | |
| Website | https://www.reha-muenster.at/ |
"ROR" |
https://ror.org/05r0e4p82 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Genzyme Corporation, Genzyme Corp.
- Location
- United States of America
Results and Publications
| Intention to publish date | 31/12/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication of results and protocol in a peer-reviewed journal. |
| IPD sharing plan | All data generated or analysed during this study will be included in the subsequent results publication. |
Editorial Notes
04/08/2025: Contact details updated.
03/07/2024: Contact details updated.
25/06/2024: The following changes were made to the study record:
1. The recruitment end date was changed from 16/06/2024 to 16/06/2026.
2. The overall trial end date was changed from 30/06/2024 to 30/06/2026.
3. The intention to publish date was changed from 31/12/2025 to 31/12/2027.
4. Study website added.
21/06/2022: The following changes were made to the study record:
1. The recruitment end date was changed from 16/06/2022 to 16/06/2024.
2. The overall trial end date was changed from 30/06/2022 to 30/06/2024.
3. The intention to publish date was changed from 31/12/2023 to 31/12/2025.
14/12/2020: Trial’s existence confirmed by Ethics review committee Medical University of Innsbruck.
