Rehabilitation in Multiple Sclerosis - Sometimes Too Much?

NCT03187847 | Completed

• 1 other identifier: 2017-00728
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Physical Activity; Fatigue; Rehabilitation

Outcome Measures

Primary Outcomes (2)

• 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.

• 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 Outcomes (2)

• 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.

• 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.

Other Outcomes (3)

• 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

• 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.

• 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.

Interventions

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).

Also known as: FSMC, HADS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• inability to follow the instructions given, e.g. language problems, psychological disorders
• no informed consent

Sponsors & Collaborators

• Klinik Valens: lead

Study Sites (1)

Kliniken Valens

Valens, 7317, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 24070256 BACKGROUND

• 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.

  PMID: 21586484 BACKGROUND

Related Links

• The Atlas of MS 2013 report

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Fatigue

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sandra Kündig, BSc

  Klinik Valens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: BSc in physical therapy

Study Record Dates

• First Submitted: May 28, 2017
• First Posted: June 15, 2017
• Study Start: August 27, 2017
• Primary Completion: March 30, 2018
• Study Completion: June 4, 2018
• Last Updated: June 12, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)