Multiple Sclerosis, Relapsing-RemittingBIPAMS-SDNCT04768777
Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
A study testing Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) in people with Multiple Sclerosis, Relapsing-Remitting and Sexual Dysfunction, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction
- What is being tested?
- Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Diagnosed of relapsing remmiting multiple sclerosis
- Relapse free in the past 30 days
- Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)
- Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction
- Internet and email access
Show all 12Show fewer
- Willingness to complete the questionnaires, wear the pedometer, and undergo randomization
- Insufficient physical activity [not meeting current physical activity guidelines based on a health contribution score of less than 14 units from the Godin Leisure-Time Exercise Questionnaire (GLTEQ)]
- Ability to ambulate without assistance [self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)]
- Age between 18 and 45 years
- English as primary language
- -
Who cannot join
- 1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35243
About this study
The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneficial effects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.
- Being tested
- Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
- Keywords
- physical activity, sexual behaviour
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction, Physiological, Motor Activity, Coitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)Behavioural
The current behavioral intervention consists of two primary components; an internet website and one-on-one video chats with a behavioral coach. The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory. Each course consists of an introduction, the primary content, and a take home message.The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries. The chats are conducted face-to-face through an online videoconferencing platform. There are a total of 12 chats over 16 weeks. Chats occur on weeks 1-8, 10-11, 13 and16.
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Intervention for Physical Activity in MS (BIPAMS) | Experimental | A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS. Receives: Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) |
| waitlist control condition | No intervention | Participants will have 16-weeks of no intervention or interaction. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Sexual Dysfunction at 16 weeks
The Female Sexual Function Index (FSFI): is a common generic measure of sexual dysfunction for women. The questionnaire consists of 19 questions that cover six subscales/domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and pain. The items further yield an overall score. Lower sum scores reflect more pronounced sexual dysfunction.
Measured: Baseline, week 16
Secondary outcomes (3)
Change from baseline Sexual Dysfunction in MS at 16 weeks
The Multiple Sclerosis Intimacy and Sexuality Questionnaire (MSISQ-19) is the most widely used self-rating tool for sexual functions in MS (Sanders et al., 2000). The MSISQ-19 consists of 19 items focusing on the perceived influence of MS symptoms on sexual activity and satisfaction and the perceived influence of MS symptoms on the overall quality of intimate relationships. The scores classifies the type of sexual dysfunction in to primary, secondary, or tertiary sexual dysfunction.
Measured: Baseline, week 16
Change from baseline Physical activity at 16 weeks
GLTEQ: Physical Activity Levels as measured by the Godin Leisure-Time Exercise Questionnaire. Participants will complete the Godin Leisure-Time Exercise Questionnaire (GLTEQ) as a measure of the frequency of strenuous, moderate, and mild leisure-time physical activity performed for periods of 15 minutes or more over a typical week. Summary scores are calculated by multiplying the number of strenuous, moderate, and mild bouts by 9, 5, and 3, respectively, and summing those values into an overall score that ranges from 0 to 119; higher scores are represent a greater volume of physical activity. This will be completed at baseline testing.
Measured: Baseline, week 16
Change from baseline physical activity duration at 16 weeks
International Physical Activity Questionnaire (IPAQ). The IPAQ was developed by a working group initiated by the World Health Organization and the Centers for Disease Control and Prevention. The IPAQ asks participants about time spent in physical activity over the last seven days. Minutes of walking, sedentary-, moderate- and vigorous-intensity activities were calculated for the past week.
Measured: Baseline, week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2021
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Responsible party
- Principal investigator, Donald Lein, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04768777
- Sponsor's protocol ID
- IRB-300006813
- Acronym
- BIPAMS-SD
- Status last verified
- Dec 2025
- First submitted
- 10 Feb 2021
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04768777
- Acronym / sponsor ID
- BIPAMS-SD / IRB-300006813
- Keywords
- physical activity, sexual behaviour
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- National Multiple Sclerosis Society
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 24 Feb 2021 (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.
The prevalence of sexual dysfunction is higher among women with multiple sclerosis (MS) than women in the general population. The presence of sexual dysfunction is associated with decreased well-being and quality of life. There is limited research supporting pharmacological and other therapeutic approaches for managing sexual dysfunction in MS. Physical activity has beneficial effects on many of the consequences of MS, and physical activity represents a promising non-pharmacological approach for managing symptoms of sexual dysfunction in MS. The proposed research examines the effect of an Internet-delivered lifestyle physical activity intervention for improving sexual dysfunction in women with MS. The research proposed, if successful, will provide evidence for the efficacy of physical activity as a translatable approach for managing sexual dysfunction among women with MS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Intervention for Physical Activity in MS (BIPAMS) | Experimental | Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS. |
| waitlist control condition | No intervention | –Participants will have 16-weeks of no intervention or interaction. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- Female
- Diagnosed of relapsing remmiting multiple sclerosis
- Relapse free in the past 30 days
- Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)
- Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction
Key exclusion criteria (2 listed)
- 1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise
- -
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 |
|---|---|---|
| Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)The current behavioral intervention consists of two primary components; an internet website and one-on-one video chats with a behavioral coach. The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory. Each course consists of an introduction, the primary content, and a take home message.The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries. The chats are conducted face-to-face through an online videoconferencing platform. There are a total of 12 chats over 16 weeks. Chats occur on weeks 1-8, 10-11, 13 and16. | Behavioural | Behavioral Intervention for Physical Activity in MS (BIPAMS) |
Primary outcome
Change from baseline Sexual Dysfunction at 16 weeks
Time frame: Baseline, week 16
The Female Sexual Function Index (FSFI): is a common generic measure of sexual dysfunction for women. The questionnaire consists of 19 questions that cover six subscales/domains of sexual function: sexual desire, sexual arousal, lubrication, orgasm, sexual satisfaction, and pain. The items further yield an overall score. Lower sum scores reflect more pronounced sexual dysfunction.
3 secondary outcomes
Change from baseline Sexual Dysfunction in MS at 16 weeks
Time frame: Baseline, week 16
Change from baseline Physical activity at 16 weeks
Time frame: Baseline, week 16
Change from baseline physical activity duration at 16 weeks
Time frame: Baseline, week 16
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) in people with Multiple Sclerosis, Relapsing-Remitting and Sexual Dysfunction, 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 12 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: opening soon, as of the sponsor's last update on 22 Dec 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Donald Lein, PhD (2059340241, dlein@uab.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Sexual Dysfunction at 16 weeks (time frame: Baseline, week 16). 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 22 Dec 2025.