Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

Study Overview
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Brief Summary
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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.

Official Title
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Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

Conditions
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Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction

Intervention / Treatment
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* Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 - Exclusion Criteria: 1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral Intervention for Physical Activity in MS (BIPAMS)<br>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)<br>* 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.<br>|
| No Intervention: waitlist control condition<br>Participants will have 16-weeks of no intervention or interaction. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Baseline, week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | Baseline, week 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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physical activity, sexual behaviour