Online Physical Activity Tracking in Patients With Multiple Sclerosis

The Effect of Online Physical Activity Tracking on Physical Activity Level, Psychological Health, Fatigue and Quality of Life in Patients With Multiple Sclerosis

This study aims to investigate the effects of regular remote monitoring of physical activity levels of individuals with multiple sclerosis on physical activity levels, psychological health, fatigue and quality of life.

Study Overview

• Status: Not yet recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Other: Physical activity tracking; Other: No physical activity tracking

Detailed Description

The study population will consist of patients with multiple sclerosis. Participants in the intervention and control groups will initially be given a brief briefing about the benefits of exercise training. Additionally, a short brochure explaining the effects of exercise in multiple sclerosis will be given. Participants in the intervention group will be allowed to join the group created by the researchers via Whatsapp. In this regard, it will be emphasized that should exercise at least 3 days a week. The participant will be asked to fill out the survey created via Google form in order to record their activity minutes in these three days. The total intervention period will be 8 weeks. Reminders to exercise will be given by the researchers in the created Whatsapp group. Participants in the control group will be encouraged to continue their routine lives. Average step counts will be recorded before and after treatment. Additionally, they will be asked to report their average step count each week via WhatsApp groups. Pre- and post-intervention evaluations will be carried out by a physiotherapist. Patients' physical activity levels, depression and anxiety, fatigue and quality of life parameters will be examined.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Busra CANDIRI; Phone Number: +9005073780717; Email: candiri_17@hotmail.com
• Study Contact Backup: Name: dilan demirtas karaoba; Email: dilandemirtas92@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

->18 years old

• Being diagnosed with multiple sclerosis according to McDonald's diagnostic criteria, owning a smartphone and using the WhatsApp application,
• Having regular internet access
• Not participating in a regular physical activity program in the last 6 months,
• Expanded Disability Status Scale<6

Exclusion Criteria:

• Having an attack during work,
• Any orthopedic or neurological disorder that affects compliance with the physical activity program,
• Not having independent mobility ability

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; Participants will receive reminders regarding physical activity promotion via the social media group created.	Other: Physical activity tracking; At the beginning, patients will be given a brief information about the benefits of exercise training. Additionally, a short brochure explaining the effects of exercise in MS will be given. Participants in the intervention group will be asked to join one of two groups created by the researchers via messaging app. Reminders will be arranged on Monday-Wednesday-Thursday in one of the groups, and on Tuesday-Thursday-Saturday in the other group. In this regard, it will be emphasized that he/she should exercise at least 3 days a week. In this regard, they will be encouraged to walk for at least 30 minutes, 3 days a week, on the days they determine. The total intervention period will be 8 weeks. Reminders to exercise will be given by the researchers in the created messaging app group. Patients will be reminded to take their mobile phones with them during physical activity and to record their daily exercise minutes.
Active Comparator: Control group; Participants will be encouraged to continue their routine lives.	Other: No physical activity tracking; At the beginning, patients will be given a brief information about the benefits of exercise training. Additionally, a short brochure explaining the effects of exercise in multiple sclerosis will be given. Participants will be encouraged to continue their routine lives and no reminders will be given.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smartphone pedometer	The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.	Baseline
Smartphone pedometer	The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.	8 week
International Physical Activity Questionnaire - Short Form	It consists of 8 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities.	Baseline
International Physical Activity Questionnaire - Short Form	It consists of 8 questions with a recall period defined as 'last week'. The questions of the scale ask whether the participant walks for at least 10 minutes on any given day or does moderate or vigorous activities, and how much time/day the individual spends on each of these activities.	8 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beck Depression Inventory II	Inventory consists of 21 items, in which four response options are presented on a scale of 0 to 3. For example, to measure pessimism (item 2) the response options used range from "I am not particularly discouraged about the future" (score of 0) to "the future is hopeless and things cannot improve" (score of 3).	Baseline
Beck Depression Inventory II	Inventory consists of 21 items, in which four response options are presented on a scale of 0 to 3. For example, to measure pessimism (item 2) the response options used range from "I am not particularly discouraged about the future" (score of 0) to "the future is hopeless and things cannot improve" (score of 3).	8 week
Beck Anxiety Inventory	The Beck Anxiety Inventory consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).	Baseline
Beck Anxiety Inventory	The Beck Anxiety Inventory consists of 21 self-reported items (four-point scale) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).	8 week
Fatigue Severity Scale	The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue	Baseline
Fatigue Severity Scale	The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue	8 week
Multiple Sclerosis Quality of Life-54	It is a multidimensional, health-related quality of life measure that combines both general and MS-specific items into a single instrument. It consists of a total of 54 items. Patients will be considered to have a better quality of life as they get closer to 100 on a 0-100 rating system.	Baseline
Multiple Sclerosis Quality of Life-54	It is a multidimensional, health-related quality of life measure that combines both general and MS-specific items into a single instrument. It consists of a total of 54 items. Patients will be considered to have a better quality of life as they get closer to 100 on a 0-100 rating system.	8 week

Collaborators and Investigators

• Sponsor: Inonu University
• Investigators: Study Director: Burcu talu, İnonu University

Study record dates

Study Major Dates

• Study Start (Estimated): February 28, 2024
• Primary Completion (Estimated): February 15, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: February 21, 2024
• First Submitted That Met QC Criteria: February 21, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; depression; Multiple sclerosis; life quality
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2023/5474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study data can be shared with other researchers if desired.
• IPD Sharing Time Frame: After the study was published
• IPD Sharing Access Criteria: If requested from the authors, it can be shared with researchers at the authors' discretion.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

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