Online Physical Activity Tracking in Patients With Multiple Sclerosis

February 21, 2024 updated by: Burcu Talu, Inonu University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Smartphone pedometer
Time Frame: Baseline
The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.
Baseline
Smartphone pedometer
Time Frame: 8 week
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
Time Frame: Baseline
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
Time Frame: 8 week
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Beck Depression Inventory II
Time Frame: Baseline
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
Time Frame: 8 week
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
Time Frame: Baseline
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
Time Frame: 8 week
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
Time Frame: Baseline
The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue
Baseline
Fatigue Severity Scale
Time Frame: 8 week
The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue
8 week
Multiple Sclerosis Quality of Life-54
Time Frame: Baseline
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
Time Frame: 8 week
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Burcu talu, Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 28, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 15, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 28, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 28, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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