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

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis; Fatigue; Quality of Life; Physical Activity

• Registration Number: NCT04115930
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-16
• Study First Submitted: 2019-04-04
• Primary Completion: 2019-06-13
• Study Completion: 2019-06-13
• Status Verified: 2019-10
• Study First Submitted QC: 2019-10-03
• Last Update Submitted: 2019-10-03
• Study First Posted: 2019-10-04
• Last Update Posted: 2019-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The Timed 25-Foot Walk test	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.	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	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	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	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	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	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	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	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)	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.	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	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.	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	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	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 Outcome Measures

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

Trial Locations

Locations (4)

Jyväskylä; 🇫🇮 Jyväskylä, Finland

University of Eastern Finland; 🇫🇮 Kuopio, Finland

Oulu; 🇫🇮 Oulu, Finland

Joensuu; 🇫🇮 Joensuu, Finland