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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04115930
Recruitment Status : Completed
First Posted : October 4, 2019
Last Update Posted : October 4, 2019
Sponsor:
Information provided by (Responsible Party):
University of Eastern Finland

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.

Condition or disease Intervention/treatment
Relapsing Remitting Multiple Sclerosis Fatigue Quality of Life Physical Activity Device: Physical Activity measurement:

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Study Type : Observational
Actual Enrollment : 61 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Correlation Between Daily Physical Activity and Disability, Fatigue, Cognition and Quality of Life in MS Patients
Actual Study Start Date : May 16, 2018
Actual Primary Completion Date : June 13, 2019
Actual Study Completion Date : June 13, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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:
7 days measurement with Active style Pro HJA-350IT device

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




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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)

  5. 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

  6. 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.)

  7. 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)

  8. 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.

  9. 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.

  10. 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.

  11. Cognition level SDMT [ Time Frame: Baseline (one measurement) ]
    Cognition will be assessed with SDMT (Symbol Digital Modality Test). Higher number is better.

  12. 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.

  13. 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.

  14. 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.

  15. General condition (endurance) [ Time Frame: Baseline (one measurement) ]
    General condition (endurance) assessed by 6-minutes walking test distance in meters.


Secondary Outcome Measures :
  1. Body Composition Weight [ Time Frame: Baseline (one measurement) ]
    Body composition evaluation assesment by weight (kg)

  2. Body Composition Height [ Time Frame: Baseline (one measurement) ]
    Body composition evaluation assesment by height (cm)

  3. Body Composition Weist [ Time Frame: Baseline (one measurement) ]
    Body composition evaluation assesment by weist (cm)

  4. Body Composition BMI [ Time Frame: Baseline (one measurement) ]
    BMI (Body Mass index). Weight and height will be combined to report BMI in kg/m^2

  5. Equilibrioception (balance) [ Time Frame: Baseline (one measurement) ]
    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)

  6. Abs strength [ Time Frame: Baseline (one measurement) ]
    Abs strength assessed by 30 seconds sit-ups (amount)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

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

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04115930


Locations
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Finland
Joensuu
Joensuu, Finland
Jyväskylä
Jyväskylä, Finland
University of Eastern Finland
Kuopio, Finland
Oulu
Oulu, Finland
Sponsors and Collaborators
University of Eastern Finland
Investigators
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Principal Investigator: Marko Luostarinen University of Eastern Finland

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Responsible Party: University of Eastern Finland
ClinicalTrials.gov Identifier: NCT04115930    
Other Study ID Numbers: PAMS
First Posted: October 4, 2019    Key Record Dates
Last Update Posted: October 4, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Fatigue
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Signs and Symptoms