Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

Not Applicable

Not yet recruiting

• Conditions: Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction
• Interventions: Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

• Registration Number: NCT04768777
• Lead Sponsor: University of Alabama at Birmingham

Brief 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. 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-10
• Study First Submitted QC: 2021-02-23
• Study First Posted: 2021-02-24
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-24
• Study Start: 2025-12-01
• Primary Completion: 2026-12-01
• Study Completion: 2026-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Female

2. Diagnosed of relapsing remmiting multiple sclerosis

3. Relapse free in the past 30 days

4. Initial confirmation of sexual dysfunction (based on a semi-structured interview on sexual dysfunction diagnostic criteria in DSM-5)

5. Currently in a committed relationship with a partner who does not have a sexual disorder or sexual dysfunction

6. Internet and email access

7. Willingness to complete the questionnaires, wear the pedometer, and undergo randomization

8. 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)]

9. Ability to ambulate without assistance [self-report and Patient-Determined Disease Steps (PDDS) score between 0 and 2 (mild ambulatory disability)]

10. Age between 18 and 45 years

11. English as primary language

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Exclusion Criteria

1. Moderate or high risk for contraindications of possible injury or death when undertaking strenous or maximal exercise

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Behavioral Intervention for Physical Activity in MS (BIPAMS)	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.

Primary Outcome Measures

Name	Time	Method
Change from baseline Sexual Dysfunction at 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline Sexual Dysfunction in MS at 16 weeks	Baseline, week 16	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.
Change from baseline Physical activity at 16 weeks	Baseline, week 16	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.
Change from baseline physical activity duration at 16 weeks	Baseline, week 16	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States