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

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Fatigue; Physical Activity; Relapsing Remitting Multiple Sclerosis
• Intervention / Treatment: Device: Physical Activity measurement:

• Study Type: Observational
• Enrollment (Actual): 61

Contacts and Locations

Study Locations

• Finland
  • Joensuu, Finland
    • Joensuu
  • Jyväskylä, Finland
    • Jyväskylä
  • Kuopio, Finland
    • University of Eastern Finland
  • Oulu, Finland
    • Oulu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Composition Weight	Body composition evaluation assesment by weight (kg)	Baseline (one measurement)
Body Composition Height	Body composition evaluation assesment by height (cm)	Baseline (one measurement)
Body Composition Weist	Body composition evaluation assesment by weist (cm)	Baseline (one measurement)
Body Composition BMI	BMI (Body Mass index). Weight and height will be combined to report BMI in kg/m^2	Baseline (one measurement)
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)	Baseline (one measurement)
Abs strength	Abs strength assessed by 30 seconds sit-ups (amount)	Baseline (one measurement)

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Investigators: Principal Investigator: Marko Luostarinen, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2018
• Primary Completion (Actual): June 13, 2019
• Study Completion (Actual): June 13, 2019

Study Registration Dates

• First Submitted: April 4, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 4, 2019

Study Record Updates

• Last Update Posted (Actual): October 4, 2019
• Last Update Submitted That Met QC Criteria: October 3, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Fatigue; Multiple Sclerosis, Relapsing-Remitting
• Other Study ID Numbers: PAMS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No