Multiple Sclerosis (MS)NCT05641532
Physical Activity in Persons Newly Diagnosed With Multiple Sclerosis
A study testing Physical activity behavioral intervention in persons newly diagnosed with MS in people with Multiple Sclerosis (MS), run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- Physical activity behavioral intervention in persons newly diagnosed with MS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Jan 2023to 8 Aug 2023
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years old
- Diagnosed with multiple sclerosis for 2 or fewer years
- Fully ambulatory
- No relapse within the last 30 days
- Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score < 14)
- Able to read 14-point font size
- Internet \& video conferencing access
- Undergoing disease-modifying therapy
Who cannot join
- Pregnancy
- Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35205
About this study
Official title: Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
This single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- Physical activity behavioral intervention in persons newly diagnosed with MS
- Keywords
- Physical activity, Newly diagnosed with MS, Behavior change, Multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity behavioral intervention in persons newly diagnosed with MSBehavioural
- The newsletters will provide the knowledge, skills, resources, and strategies for promoting physical activity in persons newly diagnosed with MS. These newsletters will be released seven times during the program. The first three newsletters will be released weekly, and the last four will be released every other week.
- The one-on-one video coaching chats with participants will be conducted via Zoom, which consist of discussion and elaboration of newsletters content, supportive accountability, feedback and encouragement on behavior change. The chats further provide social persuasion for promoting behavior change. The chats are semi-scripted and individualized interventions (~15 - 30 minutes/chat). The chats will occur seven times during the week when a newsletter is delivered.
- The intervention includes a pedometer (NL-800 pedometer), a logbook, and a calendar for tracking daily step counts, planning of physical activity, setting goals, and monitoring progress over the program.
| Study group | Role | What they receive |
|---|---|---|
| Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention | Experimental | This is a 1-arm study with an intervention condition based on the COM-B model Receives: Behavioral: Physical activity behavioral intervention in persons newly diagnosed with MS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility metric: Process
Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Measured: 12 weeks
Feasibility metric: Resource
We will assess the resources required for the study.
Measured: 12 weeks
Feasibility metric: Management
Management assesses data management.
Measured: 12 weeks
Feasibility metric: Overall safety
Overall safety will be assessed through the number of adverse events.
Measured: 12 weeks
Change of Physical Activity levels through Accelerometry from baseline and 12 weeks
Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline and 12 weeks
Measured: 12 weeks
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Measured: 12 weeks
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Measured: 12 weeks
Secondary outcomes (3)
Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks
Self report measures of fatigue will be assessed through the Fatigue Severity Scale. Participants will complete this questionnaire at baseline and 12 weeks
Measured: 12 weeks
Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks
Self report measures of quality of life will be assessed through the Multiple Sclerosis Impact Scale-29.Participants will complete this questionnaire at baseline and 12 weeks
Measured: 12 weeks
Formative evaluation
Participants' satisfaction in the study will be assessed through a self-developed survey which will be completed at 12 week.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2022
- Study start17 Jan 2023
- Primary completion8 Aug 2023
- Study completion8 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will undergo one intervention condition remotely delivered using electronic newsletters and one-on-one video coaching. Outcome measures will be assessed at two time points: baseline and post-intervention.
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Barstow, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05641532
- Sponsor's protocol ID
- IRB-300009893
- Status last verified
- Aug 2023
- First submitted
- 14 Nov 2022
- Last updated
- 16 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Activity Intervention for Persons Newly Diagnosed With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05641532
- Acronym / sponsor ID
- IRB-300009893
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Physical activity, Newly diagnosed with MS, Behavior change, Multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 17 Jan 2023 (actual)
- Primary completion
- 8 Aug 2023 (actual)
- Study completion
- 8 Aug 2023 (actual)
- First posted
- 7 Dec 2022 (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 single group pre-post pilot intervention will examine the feasibility and initial effect of a 12-week behavioral intervention, based on the Behavior Change Wheel and Capability-Opportunity-Motivation-Behavior (COM-B) model and remotely delivered through electronic newsletters and online one-on-one video conferencing, for promoting physical activity and secondarily reducing fatigue and quality of life in persons newly diagnosed with MS (diagnosed with MS within the past 2 years). The investigators hypothesize the proposed 12-week intervention will be feasible based on process, resource, management, and scientific outcomes. The investigators further hypothesize that individuals who receive the 12-week intervention will demonstrate an increase in physical activity behavior, particularly daily step counts, and reduce fatigue.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will undergo one intervention condition remotely delivered using electronic newsletters and one-on-one video coaching. Outcome measures will be assessed at two time points: baseline and post-intervention.
| Arm | Type | Receives |
|---|---|---|
| Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention | Experimental | Behavioral: Physical activity behavioral intervention in persons newly diagnosed with MSThis is a 1-arm study with an intervention condition based on the COM-B model |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years old
- Diagnosed with multiple sclerosis for 2 or fewer years
- Fully ambulatory
- No relapse within the last 30 days
- Non-active (Godin Leisure-Time Exercise Questionnaire - Health Contribution Score < 14)
Key exclusion criteria (2 listed)
- Pregnancy
- Moderate or high risk for undertaking physical activity (≥ 2 affirmatives on the Physical Activity Readiness Questionnaire)
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 behavioral intervention in persons newly diagnosed with MS1. The newsletters will provide the knowledge, skills, resources, and strategies for promoting physical activity in persons newly diagnosed with MS. These newsletters will be released seven times during the program. The first three newsletters will be released weekly, and the last four will be released every other week. 2. The one-on-one video coaching chats with participants will be conducted via Zoom, which consist of discussion and elaboration of newsletters content, supportive accountability, feedback and encouragement on behavior change. The chats further provide social persuasion for promoting behavior change. The chats are semi-scripted and individualized interventions (~15 - 30 minutes/chat). The chats will occur seven times during the week when a newsletter is delivered. 3. The intervention includes a pedometer (NL-800 pedometer), a logbook, and a calendar for tracking daily step counts, planning of physical activity, setting goals, and monitoring progress over the program. | Behavioural | Capability-Opportunity-Motivation-Behavior (COM-B) based physical activity behavioral intervention |
Primary outcome
Feasibility metric: Process
Time frame: 12 weeks
Process assesses participant recruitment, retention, and adherence i. Recruitment and refusal rates ii. Retention, attrition, and adherence rates to study procedures
Feasibility metric: Resource
Time frame: 12 weeks
We will assess the resources required for the study.
Feasibility metric: Management
Time frame: 12 weeks
Management assesses data management.
Feasibility metric: Overall safety
Time frame: 12 weeks
Overall safety will be assessed through the number of adverse events.
Change of Physical Activity levels through Accelerometry from baseline and 12 weeks
Time frame: 12 weeks
Physical activity will be assessed using an ActiGraph accelerometer. Participants will wear an accelerometer on a belt around their waist during the waking hours of a 7 day period. Participants will complete this at baseline and 12 weeks
Change of Physical Activity levels through the Godin Leisure-Time Exercise Questionnaire from baseline and 12 weeks
Time frame: 12 weeks
Physical activity will be assessed using the Godin Leisure-Time Exercise Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
Change of Physical Activity levels through the Abbreviated International Physical Activity Questionnaire from baseline and 12 weeks
Time frame: 12 weeks
Physical activity will be assessed using the Abbreviated International Physical Activity Questionnaire. Participants will complete this questionnaire at baseline and 12 weeks.
3 secondary outcomes
Change of self-report measures of Fatigue through the Fatigue Severity Scale from baseline and 12 weeks
Time frame: 12 weeks
Changes of self-report measures of quality of life through the Multiple Sclerosis Impact Scale-29 at baseline and 12 weeks
Time frame: 12 weeks
Formative evaluation
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity behavioral intervention in persons newly diagnosed with MS in people with Multiple Sclerosis (MS), run by University of Alabama at Birmingham at 1 site in United States.
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 8 inclusion and 2 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: finished, as of the sponsor's last update on 16 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility metric: Process (time frame: 12 weeks). The study lists 7 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 16 Aug 2023.