An interventional study of Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) in Multiple Sclerosis, Relapsing-Remitting and Sexual Dysfunction, sponsored by University of Alabama at Birmingham. Not yet recruiting at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2025-12-22.
Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Supportive care
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.
618 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 82 are open to participants now.
This study's planned enrollment of 30 is below the median of 66 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.
Browse Multiple Sclerosis, Relapsing-Remitting studies →University of Alabama at Birmingham is the lead sponsor of 1,421 studies on the registry; 277 are open to participants now.
Of its 164 completed or terminated interventional studies of FDA-regulated products, 130 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
English as primary language
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Exclusion Criteria:
1. Moderate or high risk for of possible injury or death when undertaking strenous or maximal exercise
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
Participants will have 16-weeks of no intervention or interaction.
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.
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.
Time frame: Baseline, week 16
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, week 16
Stability and changes of Fatigue over time
Fatigue Severity Scale (FSS); scores range between 1 (min) and 7 (max), higher scores reflect greater fatigue severity.
Time frame: Baseline, week 16
Change from Baseline Depression at 16 weeks
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time frame: Baseline, week 16
Change from Baseline Anxiety at 16 weeks
Hospital Anxiety and Depression Scale (HADS); scores range between 0 (min) and 21 (max), higher scores reflect greater frequency of anxiety and depressive symptoms.
Time frame: Baseline, week 16
Change from Baseline Subjective sleep complaints at 16 weeks
Insomnia Severity Index (ISI). This questionnaire is a seven-item screening measure for insomnia. The items, answered on a 5-point Likert scale ranging from 0 (=not at all) to 4 (=very much), refer in part to the Diagnostic and Statistical Manual of Mental Disorders criteria for insomnia by assessing difficulty falling asleep, difficulty remaining asleep, early morning awakenings, impaired daytime performance, low satisfaction with sleep, and worry about sleep. The higher the overall score, the more the participant is assumed to suffer from insomnia.
Time frame: Baseline, week 16
Change from Baseline Feelings of Loneliness at 16 weeks
Short-form UCLA Loneliness Scale is a 3-item scale designed to measure one's subjective feelings of loneliness as well as feelings of social isolation.
Time frame: Baseline, week 16
Change from Baseline Pain severity at 16 weeks
Short-form of McGill Pain Questionnaire : Change of self-report measures of Pain through the Short-form of McGill Pain.
Time frame: Baseline, week 16
Change from Baseline Emotion Regulation at 16 weeks
Emotion Regulation Questionnaire(ERQ): A 10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert scale ranging from 1 (strongly disagree) to 7 (strongly agree). Lowersscores reflects better emotion regulation.
Time frame: Baseline, week 16
Change from Baseline Couple Satisfaction at 16 weeks
Couple Satisfaction Index (CSI-4), is a seven-item questionnaire for assessing the level of couple satisfaction. The answers are given on a 7-point Likert scale (for question 1) and 6-point Likert scale (for question 2-4) with the following anchor points 0 (= extremely unhappy/not at all satisfied) to 6 or 5 (= Perfect/completely satisfied).
Time frame: Baseline, week 16
Start is estimated for Dec 2026; primary completion for Dec 2026, 0 months later.
Of 79 non-industry interventional studies with no phase under Multiple Sclerosis, Relapsing-Remitting, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 45. This study's planned 0 months is below that.
Counting every sponsor, half of 81 studies reached it within 29 months; a quarter within 15 and three quarters within 47.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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