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Rehabilitation in Multiple Sclerosis - Sometimes Too Much?

K

Klinik Valens

Status

Completed

Conditions

Multiple Sclerosis

Treatments

Device: Actigraph GT3X

Study type

Observational

Funder types

Other

Identifiers

NCT03187847
2017-00728

Details and patient eligibility

About

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.

Full 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.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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