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Clinical Trials/NCT04115930
NCT04115930
Completed
Not Applicable

Correlation Between Daily Physical Activity and Disability, Fatigue, Cognition and Quality of Life in MS Patients

University of Eastern Finland4 sites in 1 country61 target enrollmentMay 16, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Relapsing Remitting Multiple Sclerosis
Sponsor
University of Eastern Finland
Enrollment
61
Locations
4
Primary Endpoint
The Timed 25-Foot Walk test
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 16, 2018
End Date
June 13, 2019
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

The Timed 25-Foot Walk test

Time Frame: Baseline (one measurement)

The Timed 25-Foot Walk test is a quantitative measure of lower extremity function. The patient is directed to one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly as possible. Record the subject's walk time to within 0.1 second, lower time is better)

Correlation between daily physical activity and quality of life to disability.

Time Frame: Baseline (one measurement)

Daily physical activity will be measured 7 days assessed by ActiGraphTM wGT3X-BT. Person keep this on his/her wake-up time whole 7 days excluding time when she/he is in water like in shower or swimming. Quality of life will be assessed by questionnaires 15-D and RAND-36 and disability will be assessed by EDSS (Expanded Disability Status Scale) and also with MSFC (Multiple Sclerosis Functional Composite) measurement.

Disability level MSFC

Time Frame: Baseline (one measurement)

Disability will be assessed MSFC (Multiple Sclerosis Functional Composite) measurement. Test include three different kind of test The Timed 25-Foot Walk Test, The 9-HPT (9-hole peg test) and The Paced Auditory Serial Addition Test "PASAT"). The MSFC is based on the concept that scores for these three dimensions-arm, leg, and cognitive function are combined to create a single score (the MSFC) that can be used to detect change over time in a group of multiple sclerosis patients. This is done by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score known as the MSFC score. ex. MSFC Score = {Zarm, average + Zleg, average + Zcognitive} / 3.0 Where Zxxx =Z-score

9-Hole Peg Test

Time Frame: Baseline (one measurement)

The 9-HPT (9-hole peg test). The 9-HPT is a quantitative measure of upper extremity (arm and hand) function. Both the dominant and non-dominant hands are tested twice (two consecutive trials of the dominant hand, followed immediately by two consecutive trials of the non-dominant hand). Record only the times for the two successfully completed trials for each hand. (time/within 0.1 seconds,lower time is better.)

Daily physical activity

Time Frame: 7 days

Daily physical activity will be measured 7 days with measure ActiGraphTM wGT3X-BT. Person keep this on his/her wake-up time whole 7 days excluding time when she/he is in water like in shower or swimming.

Fatigue level MFIS

Time Frame: Baseline (one measurement)

Fatigue will be assessed with questionnaire MFIS (Modified Fatigue Impact Scale). 21 questions. (scale 0 to 4 in every questions/ range 0 to 84 in whole questionnaire). Higher number is worse.

Disability level EDSS

Time Frame: Baseline (one measurement)

Disability will be assessed EDSS (Expanded Disability Status Scale). Scale range is between 0 to 10. (0 level is normal and 10 means death)

Quality of life 15-D

Time Frame: Baseline (one measurement)

Quality of life level will be assessed questionnaire 15-D. 15 question (evaluation 5 class in every question= 1 to 5 points) Count together and higher number is worse.

Quality of life RAND-36

Time Frame: Baseline (one measurement)

Quality of life level will be assessed questionnaire RAND-36.(include 36 question in 8 different kind of section). Higher number is worse.

General condition (endurance)

Time Frame: Baseline (one measurement)

General condition (endurance) assessed by 6-minutes walking test distance in meters.

Correlation between fatigue, cognition, quality of life and daily physical activity.

Time Frame: Baseline (one measurement)

Fatigue will be assessed with two different questionnaires FSS (fatigue severity scale) and MFIS (Modified Fatigue Impact Scale). Cognition will be assessed SDMT (Symbol Digital Modality Test) and PASAT-test. Quality of life will be assessed questionnaires 15-D and RAND-36. Daily physical activity will be measured 7 days with measure ActiGraphTM wGT3X-BT. Person keep this on his/her wake-up time whole 7 days excluding time when she/he is in water like in shower or swimming.

Cognition level SDMT

Time Frame: Baseline (one measurement)

Cognition will be assessed with SDMT (Symbol Digital Modality Test). Higher number is better.

Correlation between fatigue and cognition to daily physical activity and disability.

Time Frame: Baseline (one measurement)

Fatigue will be assessed with two different questionnaires FSS (fatigue severity scale) and MFIS (Modified Fatigue Impact Scale). Cognition will be assessed SDMT (Symbol Digital Modality Test) and PASAT-test. Daily physical activity will be measured 7 days with measure ActiGraphTM wGT3X-BT. Person keep this on his/her wake-up time whole 7 days excluding time when she/he is in water like in shower or swimming. Disability will be assessed EDSS (Expanded Disability Status Scale) and also with MSFC (Multiple Sclerosis Functional Composite) measurement.

Cognition level PASAT

Time Frame: Baseline (one measurement)

Cognition will be assessed with PASAT-test.(Paced Auditory Serial Addition Test). The test score is the number of correct sums given (out of 60 possible) in each trial. Higher number is better.

Fatigue level FSS

Time Frame: Baseline (one measurement)

Fatigue will be assessed with questionnaire FSS (fatigue severity scale). FSS questionaire containing nine statements that attempt to explore severity of fatigue symptoms. The subject is asked to read each statement and circle a number from 1 to 7. The scoring is done by calculating the average response to the questions (adding up all the answers and dividing by nine). Higher number is worse.

Secondary Outcomes

  • Body Composition Weight(Baseline (one measurement))
  • Body Composition Height(Baseline (one measurement))
  • Equilibrioception (balance)(Baseline (one measurement))
  • Body Composition Weist(Baseline (one measurement))
  • Body Composition BMI(Baseline (one measurement))
  • Abs strength(Baseline (one measurement))

Study Sites (4)

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