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Relapsing Remitting Multiple SclerosisPAMSNCT04115930

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

An observational study of Relapsing Remitting Multiple Sclerosis and Fatigue, run by University of Eastern Finland at 4 sites in Finland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
What is being tested?
Physical Activity measurement:
Type of treatment
Medical device
How many people
61 participants
Where
4 sitesFinland
Study dates
16 May 2018to 13 Jun 2019
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

4 sites in 1 country.

Finland4 sites

  • Joensuu

    Joensuu

  • Jyväskylä

    Jyväskylä

  • University of Eastern Finland

    Kuopio

  • Oulu

    Oulu

Other trials in Finland

About this study

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

Being tested
Physical Activity measurement:
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting, Fatigue, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical Activity measurement:Device

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

Study groups in NCT04115930
Study groupRoleWhat they receive
PatientFatigue, 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.
Receives: Device: Physical Activity measurement:
ControlHealthy 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.
Receives: Device: Physical Activity measurement:

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline (one measurement)

  2. 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.

    Measured: Baseline (one measurement)

  3. 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.

    Measured: Baseline (one measurement)

  4. 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)

    Measured: Baseline (one measurement)

  5. 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

    Measured: Baseline (one measurement)

  6. 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.)

    Measured: Baseline (one measurement)

  7. 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)

    Measured: Baseline (one measurement)

  8. 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.

    Measured: 7 days

  9. 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.

    Measured: Baseline (one measurement)

  10. 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.

    Measured: Baseline (one measurement)

  11. Cognition level SDMT

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

    Measured: Baseline (one measurement)

  12. 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.

    Measured: Baseline (one measurement)

  13. 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.

    Measured: Baseline (one measurement)

  14. 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.

    Measured: Baseline (one measurement)

  15. General condition (endurance)

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

    Measured: Baseline (one measurement)

Secondary outcomes (6)

  1. Body Composition Weight

    Body composition evaluation assesment by weight (kg)

    Measured: Baseline (one measurement)

  2. Body Composition Height

    Body composition evaluation assesment by height (cm)

    Measured: Baseline (one measurement)

  3. Body Composition Weist

    Body composition evaluation assesment by weist (cm)

    Measured: Baseline (one measurement)

  4. Body Composition BMI

    BMI (Body Mass index). Weight and height will be combined to report BMI in kg/m^2

    Measured: Baseline (one measurement)

  5. Equilibrioception (balance)

    Equilibrioception evaluation by Berg´s balance scale. 14 different part and scale in every part 0 to 4. Count together and whole test range 0 to 56. (Higher is better)

    Measured: Baseline (one measurement)

  6. Abs strength

    Abs strength assessed by 30 seconds sit-ups (amount)

    Measured: Baseline (one measurement)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2019
  2. Study start16 May 2018
  3. Primary completion13 Jun 2019
  4. Study completion13 Jun 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
61 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04115930
Sponsor's protocol ID
PAMS
Acronym
PAMS
Status last verified
Oct 2019
First submitted
4 Apr 2019
Last updated
4 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40535778

Questions about this trial

What is this clinical trial studying?

An observational study of Relapsing Remitting Multiple Sclerosis and Fatigue, run by University of Eastern Finland at 4 sites in Finland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Correlation between daily physical activity and quality of life to disability. (time frame: Baseline (one measurement)). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04115930, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2019.

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