Clinical trial NCT04768777: Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Official title: Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Multiple Sclerosis, Relapsing-Remitting
Sexual Dysfunction
Keywords: physical activity
sexual behaviour
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2021-02-24
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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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Primary outcomes:
measure: Change from baseline Sexual Dysfunction at 16 weeks
timeFrame: Baseline, week 16
Secondary outcomes:
measure: Change from baseline Sexual Dysfunction in MS at 16 weeks
timeFrame: Baseline, week 16
measure: Change from baseline Physical activity at 16 weeks
timeFrame: Baseline, week 16
measure: Change from baseline physical activity duration at 16 weeks
timeFrame: Baseline, week 16
Other outcomes:
measure: Stability and changes of Fatigue over time
timeFrame: Baseline, week 16
measure: Change from Baseline Depression at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Anxiety at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Subjective sleep complaints at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Feelings of Loneliness at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Pain severity at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Emotion Regulation at 16 weeks
timeFrame: Baseline, week 16
measure: Change from Baseline Couple Satisfaction at 16 weeks
timeFrame: Baseline, week 16
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
References: