Clinical trial NCT04115930: Correlation Between Daily Physical Activity and Disability, Fatigue, Cognition and Quality of Life in MS Patients
Official title: Correlation Between Daily Physical Activity and Disability, Fatigue, Cognition and Quality of Life in MS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis
Fatigue
Quality of Life
Physical Activity
Lead sponsor: University of Eastern Finland
Sponsor class: OTHER
First posted: 2019-10-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient group: RRMS patients (18-55 years old)

Control group: Healthy volunteers (18-55 years old)

Brief summary: The main purpose of the study is to assess the fatigue, cognition, quality of life and disability correlation to MS-patients daily physical activity.


Eligibility criteria: Inclusion Criteria:

* RR-MS (relapsing-remitting MS-disease)
* Age 18-55y
* Expanded Disability Status Scale (EDSS) score less than equals to (\<=) 5.5
* Not relapse in previous month
* Other protocol defined inclusion criteria could apply

Exclusion Criteria:

* PP-MS (primary progressive disease)
* SPMS (secondary progressive disease)
* Other protocol defined exclusion criteria could apply.

Primary outcomes:
measure: Correlation between daily physical activity and quality of life to disability.
timeFrame: Baseline (one measurement)
measure: Correlation between fatigue and cognition to daily physical activity and disability.
timeFrame: Baseline (one measurement)
measure: Correlation between fatigue, cognition, quality of life and daily physical activity.
timeFrame: Baseline (one measurement)
measure: Disability level EDSS
timeFrame: Baseline (one measurement)
measure: Disability level MSFC
timeFrame: Baseline (one measurement)
measure: 9-Hole Peg Test
timeFrame: Baseline (one measurement)
measure: The Timed 25-Foot Walk test
timeFrame: Baseline (one measurement)
measure: Daily physical activity
timeFrame: 7 days
measure: Quality of life 15-D
timeFrame: Baseline (one measurement)
measure: Quality of life RAND-36
timeFrame: Baseline (one measurement)
measure: Cognition level SDMT
timeFrame: Baseline (one measurement)
measure: Cognition level PASAT
timeFrame: Baseline (one measurement)
measure: Fatigue level FSS
timeFrame: Baseline (one measurement)
measure: Fatigue level MFIS
timeFrame: Baseline (one measurement)
measure: General condition (endurance)
timeFrame: Baseline (one measurement)
Secondary outcomes:
measure: Body Composition Weight
timeFrame: Baseline (one measurement)
measure: Body Composition Height
timeFrame: Baseline (one measurement)
measure: Body Composition Weist
timeFrame: Baseline (one measurement)
measure: Body Composition BMI
timeFrame: Baseline (one measurement)
measure: Equilibrioception (balance)
timeFrame: Baseline (one measurement)
measure: Abs strength
timeFrame: Baseline (one measurement)
Other outcomes:
Locations:
city: Joensuu
country: Finland
facility: Joensuu
city: Jyväskylä
country: Finland
facility: Jyväskylä
city: Kuopio
country: Finland
facility: University of Eastern Finland
city: Oulu
country: Finland
facility: Oulu
Study officials:
affiliation: University of Eastern Finland
name: Marko Luostarinen
role: PRINCIPAL_INVESTIGATOR
References: