Clinical trial NCT03187847: Rehabilitation in Multiple Sclerosis - Sometimes Too Much?
Official title: Changes in Perceived Fatigue and Step Counts Before and After Rehabilitation. A Prospective, Single-center, Longitudinal Observational Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Physical Activity
Fatigue
Rehabilitation
Lead sponsor: Klinik Valens
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigator plans to include at least 20 patients with multiple sclerosis with an EDSS 3-6.5, who come to Valens for rehabilitation from the end of August 2017 until July 2018.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Fatigue
timeFrame: 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.
measure: Changes in Physical Activity/Step Counts (Actigraph GT3X)
timeFrame: 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.
Secondary outcomes:
measure: quality of life in association with changes in fatigue and physical activity
timeFrame: 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.
measure: emotional status (depression) in association with changes in fatigue and physical activity
timeFrame: 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.
Other outcomes:
measure: diary while wearing the Actigraph device
timeFrame: 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
measure: 2 minute walking test
timeFrame: 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.
measure: Timed up and Go
timeFrame: 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.
Locations:
city: Valens
country: Switzerland
facility: Kliniken Valens
Study officials:
affiliation: Klinik Valens
name: Sandra Kündig, BSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kingwell E, Marriott JJ, Jette N, Pringsheim T, Makhani N, Morrow SA, Fisk JD, Evans C, Beland SG, Kulaga S, Dykeman J, Wolfson C, Koch MW, Marrie RA. Incidence and prevalence of multiple sclerosis in Europe: a systematic review. BMC Neurol. 2013 Sep 26;13:128. doi: 10.1186/1471-2377-13-128.
citation: Rietberg MB, van Wegen EE, Uitdehaag BM, Kwakkel G. The association between perceived fatigue and actual level of physical activity in multiple sclerosis. Mult Scler. 2011 Oct;17(10):1231-7. doi: 10.1177/1352458511407102. Epub 2011 May 17.