Skip to main content
OpenTrials
Completed

NCT Number: NCT03187847

Rehabilitation in Multiple Sclerosis - Sometimes Too Much?

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Fatigue Immune System Diseases Motor Activity Nervous System Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Kliniken Valens

Valens, 7317, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Actigraph GT3X

Device

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).

Other names: FSMC, HADS

Primary outcomes

  1. Changes in Fatigue

    Time frame: 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.

  2. Changes in Physical Activity/Step Counts (Actigraph GT3X)

    Time frame: 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 outcomes

  1. quality of life in association with changes in fatigue and physical activity

    Time frame: 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.

  2. emotional status (depression) in association with changes in fatigue and physical activity

    Time frame: 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 outcomes

  1. diary while wearing the Actigraph device

    Time frame: 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.

  2. 2 minute walking test

    Time frame: 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

  3. Timed up and Go

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Klinik Valens

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 15, 2017
Registry last updated
Jun 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.