Multiple Sclerosis
Conditions
Keywords
Physical Activity, Fatigue, Rehabilitation
Brief summary
The primary objective is to evaluate changes in fatigue and physical activity (step counts) before and after rehabilitation in patients with MS (EDSS 3-6.5). The association of changes in fatigue and physical activity will also be analyzed for disease severity (EDSS), age, emotional status (depression) of the participants.
Detailed description
Around 2 million people worldwide have multiple sclerosis (MS) and it is the most common neurological disease in young adults. The greatest incidence of MS is found in Europe (108 per 100'000). Over 50% of the patients with MS suffer from fatigue and reduced physical activity. The association between inactivity and fatigue is low in patients with mild disability. Rehabilitation in Valens includes intensive strength and endurance training. Endurance and walking improve in most patients, evaluated during rehabilitation with the Timed-Up and Go (TUG) and 2 minute walking tests (2MWT). However, Clinic Valens occasionally gets feedback from physical therapists in the ambulatory setting, that outcome after rehabilitation is sometimes poor and some patients with MS (pwMS) seem to be over trained, less mobile, more fatigued and need to recover for several weeks. Physical therapists in Valens know that training is fatiguing. If they knew how many, and which patients are more fatigued and less active after rehabilitation they could reduce treatment intensity and prevent overtraining. To the knowledge of the investigators no study evaluated changes after rehabilitation in fatigue, assessed with a disease specific questionnaire (FSMC), and mobility at home using accelerometers. Potential predictors of poor outcome are disease severity (EDSS), pre-rehabilitation fatigue and depression. The primary goal of this study therefore is to evaluate changes in fatigue and physical activity (step counts) in pwMS assessed before rehabilitation, after rehabilitation and at 2 months follow-up.
Interventions
DEVICEActigraph GT3X
The primary outcomes are measured by the Actigraph GT3X (step counts) and FSMC (fatigue scale for motor and cognitive functions questionnaire) at three different points in time (Actigraph is worn for three weeks in total). The secondary outcomes are emotional status, measured by the hospital anxiety and depression scale (HADS) and quality of life, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS).
Sponsors
Klinik Valens
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* EDSS 3-6.5, an EDSS 6.5 means the ability to walk 20 meters without resting, using constant bilateral assistance * \>18 years old * German speaking * good function of the upper extremity to put on Actigraph by themselves * participants should be able to wear the Actigraph at least 6h/day for 7 days
Exclusion criteria
* inability to follow the instructions given, e.g. language problems, psychological disorders * no informed consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Fatigue | Fatigue will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant. | The primary objective is to evaluate changes in fatigue before and after rehabilitation in patients with MS (EDSS 3-6.5). Fatigue will be assessed with the FSMC questionnaire at three different time points. |
| Changes in Physical Activity/Step Counts (Actigraph GT3X) | The Actigraph device will be worn for three weeks in total. Before rehabilitation (whle participants are still at home), the week right after rehabilitation and at 2 months follow up. | The primary objective is to evaluate changes in physical activity (steps per day) before and after rehabilitation in patients with MS (EDSS 3-6.5). This will be measured by the Actigraph GT3X at three different time points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of life in association with changes in fatigue and physical activity | The quality of life will be assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant. | The association of changes in fatigue and physical activity will also be analyzed for quality of life of the participants. This will be measured by the Hamburg Quality of Life Questionnaire (HAQUAMS) at three different time points. |
| emotional status (depression) in association with changes in fatigue and physical activity | The emotional status will be first assessed before rehabilitation in Valens, the week right after rehabilitation and at 2 months follow-up with a questionnaire given to the participant. | The association of changes in fatigue and physical activity will also be analyzed for the emotional status of the participants. This will be measured by the hospital anxiety and depression scale (HADS) at three different time points. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 2 minute walking test | on the first day of rehabilitation and on the last day of rehabilitation, around 3 weeks between the two measurement time points. The rehabilitation in Valens will be planned between August 2017 and July 2018. | 2MWT (2 minute walking test) to see changes in walking speed and distance before and after rehabilitation in Valens |
| Timed up and Go | on the first day of rehabilitation and on the last day of rehabilitation, around 3 weeks between the two measurement time points. The rehabilitation in Valens will be planned between August 2017 and July 2018. | TUG (timed up and go) will be assessed before and after rehabilitation to see changes in equilibrium and walking abilities |
| diary while wearing the Actigraph device | While measuring physical activity by the Actigraph a diary will be completed during one week before rehabilitation, the week right after rehabilitation and at 2 months follow-up | A diary to record other activities than walking e.g. cycling, yoga, swimming will be provided during the 7 days of measurement with the Actigraph, because the device is not able to detect activities like yoga or cycling. |
Countries
Switzerland
Outcome results
None listed