Online Physical Activity Tracking in Patients With Multiple Sclerosis

NCT06283563 | Not Yet Recruiting

• 1 other identifier: 2023/5474
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Multiple Sclerosis

Keywords

physical activity; depression; life quality; Multiple sclerosis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (8)

• Beck Depression Inventory II

  Baseline

• Beck Depression Inventory II

  8 week

• Beck Anxiety Inventory

  Baseline

• Beck Anxiety Inventory

  8 week

• Fatigue Severity Scale

  Baseline

Study Arms (2)

Experimental group

EXPERIMENTAL

Participants will receive reminders regarding physical activity promotion via the social media group created.

Other: Physical activity tracking

Control group

ACTIVE COMPARATOR

Participants will be encouraged to continue their routine lives.

Other: No physical activity tracking

Interventions

Physical activity tracking OTHER

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.

Experimental group

No physical activity tracking OTHER

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \>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

You may not qualify if:

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

Sponsors & Collaborators

• Inonu University: lead

MeSH Terms

Conditions

Multiple Sclerosis; Motor Activity; Depression

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Behavior; Behavioral Symptoms

Study Officials

• BURCU talu

  Inonu University

  STUDY DIRECTOR

Central Study Contacts

BUSRA CANDIRI

CONTACT

+9005073780717; candiri_17@hotmail.com

Dilan DEMIRTAS KARAOBA

CONTACT

dilandemirtas92@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 21, 2024
• First Posted: February 28, 2024
• Study Start: February 28, 2024
• Primary Completion: February 15, 2025
• Study Completion: February 28, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After the study was published
• Access Criteria: If requested from the authors, it can be shared with researchers at the authors' discretion.