Online Physical Activity Tracking in Patients With Multiple Sclerosis

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283563
• Other study ID #: 2023/5474
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2024
• Source: Inonu University
• Contact: BUSRA CANDIRI
• Phone: +9005073780717
• Email: candiri_17[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 10
• Est. completion date: February 28, 2025
• Est. primary completion date: February 15, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smartphone pedometer	The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.	Baseline
Primary	Smartphone pedometer	The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.	8 week
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fatigue Severity Scale	The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue	Baseline
Secondary	Fatigue Severity Scale	The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue	8 week
Secondary	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
Secondary	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