Rehabilitation in Multiple Sclerosis - Sometimes Too Much?

Multiple Sclerosis Clinical Trial

Official title:

Changes in Perceived Fatigue and Step Counts Before and After Rehabilitation. A Prospective, Single-center, Longitudinal Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03187847
• Other study ID #: 2017-00728
• Status: Completed
• Start date: August 27, 2017
• Est. completion date: June 4, 2018

Study information

• Verified date: June 2018
• Source: Klinik Valens
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 4, 2018
• Est. primary completion date: March 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• Actigraph 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).

Locations

Country	Name	City	State
Switzerland	Kliniken Valens	Valens

Sponsors (1)

Lead Sponsor	Collaborator
Klinik Valens

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

Kingwell E, Marriott JJ, Jetté N, Pringsheim T, Makhani N, Morrow SA, Fisk JD, Evans C, Béland 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	diary while wearing the Actigraph device	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.	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
Other	2 minute walking test	2MWT (2 minute walking test) to see changes in walking speed and distance before and after rehabilitation in Valens	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.
Other	Timed up and Go	TUG (timed up and go) will be assessed before and after rehabilitation to see changes in equilibrium and walking abilities	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.
Primary	Changes in Fatigue	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.	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.
Primary	Changes in Physical Activity/Step Counts (Actigraph GT3X)	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.	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	quality of life in association with changes in fatigue and physical activity	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.	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.
Secondary	emotional status (depression) in association with changes in fatigue and physical activity	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.	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.

External Links

•   The Atlas of MS 2013 report