Multiple SclerosisNCT06283563
Online Physical Activity Tracking in Patients With Multiple Sclerosis
A study testing Physical activity tracking and No physical activity tracking in people with Multiple Sclerosis, run by Inonu University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Physical activity tracking and No physical activity tracking
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2024to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- ->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
Who cannot join
- Having an attack during work,
- Any orthopedic or neurological disorder that affects compliance with the physical activity program,
- Not having independent mobility ability
Trial locations and contacts
No sites are listed yet.
Dilan DEMIRTAS KARAOBA contact
About this study
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
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Physical activity tracking, No physical activity tracking
- Keywords
- physical activity, depression, life quality, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Motor Activity, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity trackingOther
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 trackingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Participants will receive reminders regarding physical activity promotion via the social media group created. Receives: Other: Physical activity tracking |
| Control group | Active comparator | Participants will be encouraged to continue their routine lives. Receives: Other: No physical activity tracking |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smartphone pedometer
The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.
Measured: Baseline
Smartphone pedometer
The number of steps in the pedometer application of the current smartphone on the individual's phone will be recorded.
Measured: 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.
Measured: 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.
Measured: 8 week
Secondary outcomes (8)
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 8 week
Fatigue Severity Scale
The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue
Measured: Baseline
Fatigue Severity Scale
The classification is <36 mild no fatigue, 36-52 = moderate fatigue and >52 severe fatigue
Measured: 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.
Measured: 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.
Measured: 8 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start28 Feb 2024 (estimated)
- Primary completion15 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Talu, Inonu University
- Investigators
- BURCU talu, Study director, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06283563
- Sponsor's protocol ID
- 2023/5474
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data can be shared with other researchers if desired.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06283563
- Acronym / sponsor ID
- 2023/5474
- Conditions
- Multiple Sclerosis
- Keywords
- physical activity, depression, life quality, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (estimated)
- Primary completion
- 15 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 28 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Physical activity trackingParticipants will receive reminders regarding physical activity promotion via the social media group created. |
| Control group | Active comparator | Other: No physical activity trackingParticipants will be encouraged to continue their routine lives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ->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
Key exclusion criteria (3 listed)
- Having an attack during work,
- Any orthopedic or neurological disorder that affects compliance with the physical activity program,
- Not having independent mobility ability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity trackingAt 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. | Other | Experimental group |
| No physical activity trackingAt 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. | Other | Control group |
Primary outcome
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.
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.
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.
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 secondary outcomes
Beck Depression Inventory II
Time frame: Baseline
Beck Depression Inventory II
Time frame: 8 week
Beck Anxiety Inventory
Time frame: Baseline
Beck Anxiety Inventory
Time frame: 8 week
Fatigue Severity Scale
Time frame: Baseline
Fatigue Severity Scale
Time frame: 8 week
Multiple Sclerosis Quality of Life-54
Time frame: Baseline
Multiple Sclerosis Quality of Life-54
Time frame: 8 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: Yes. Study data can be shared with other researchers if desired.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dilan DEMIRTAS KARAOBA contact
BURCU talu study director
Inonu University
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity tracking and No physical activity tracking in people with Multiple Sclerosis, run by Inonu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact BUSRA CANDIRI (+9005073780717, candiri_17@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smartphone pedometer (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2024.