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

NCT04115930 | Completed

• 1 other identifier: PAMS
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 4

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.

Conditions

Relapsing Remitting Multiple Sclerosis; Fatigue; Quality of Life; Physical Activity

Outcome Measures

Primary Outcomes (15)

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

  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.

  Baseline (one measurement)

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

  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.

  Baseline (one measurement)

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

  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.

  Baseline (one measurement)

• Disability level EDSS

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

  Baseline (one measurement)

• Disability level MSFC

  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

  Baseline (one measurement)

• 9-Hole Peg Test

  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.)

  Baseline (one measurement)

• The Timed 25-Foot Walk test

  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)

  Baseline (one measurement)

• Daily physical activity

  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.

  7 days

• Quality of life 15-D

  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.

  Baseline (one measurement)

• Quality of life RAND-36

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

  Baseline (one measurement)

• Cognition level SDMT

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

  Baseline (one measurement)

• Cognition level PASAT

  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.

  Baseline (one measurement)

• Fatigue level FSS

  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.

  Baseline (one measurement)

• Fatigue level MFIS

  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.

  Baseline (one measurement)

• General condition (endurance)

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

  Baseline (one measurement)

Secondary Outcomes (6)

• Body Composition Weight

  Baseline (one measurement)

• Body Composition Height

  Baseline (one measurement)

• Body Composition Weist

  Baseline (one measurement)

• Body Composition BMI

  Baseline (one measurement)

• Equilibrioception (balance)

  Baseline (one measurement)

Study Arms (2)

Patient

Fatigue, cognition and quality of life measurements with different kind of tests and forms. EDSS and SFMC. Daily physical activity measurement 7days. Berg´s scale. Sit-Up 30 s and 6-minutes walking test. Length, weight and waist measurements.

Device: Physical Activity measurement:

Control

Healthy volunteers. Fatigue, cognition and quality of life measurements with different kind of tests and forms. SFMC. Daily physical activity measurement 7days. Berg´s scale. Sit-Up 30 s and 6-minutes walking test. Length, weight and waist measurements.

Device: Physical Activity measurement:

Interventions

Physical Activity measurement: DEVICE

7 days measurement with Active style Pro HJA-350IT device

Control; Patient

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• PP-MS (primary progressive disease)
• SPMS (secondary progressive disease)

Sponsors & Collaborators

• University of Eastern Finland: lead

Study Sites (4)

Joensuu

Joensuu, Finland

Location

Jyväskylä

Jyväskylä, Finland

Location

University of Eastern Finland

Kuopio, Finland

Location

Oulu

Oulu, Finland

Location

Related Publications (1)

• Luostarinen M, Portaankorva AM, Urpilainen P, Takala S, Venojarvi M. Correlation of Cognition With Disability and Physical Performance in Patients With Relapsing-Remitting MS. J Cent Nerv Syst Dis. 2025 Jun 17;17:11795735251349716. doi: 10.1177/11795735251349716. eCollection 2025.

  PMID: 40535778 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Fatigue; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Marko Luostarinen

  University of Eastern Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2019
• First Posted: October 4, 2019
• Study Start: May 16, 2018
• Primary Completion: June 13, 2019
• Study Completion: June 13, 2019
• Last Updated: October 4, 2019

Record last verified: 2019-10

Locations

FI (4)