Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
University of Alabama at Birmingham
Study ID
NCT04768777
Status
Not Yet Recruiting

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Conditions

  • Multiple Sclerosis, Relapsing-Remitting
  • Sexual Dysfunction

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) — BEHAVIORAL
    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 Details

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.

Key Dates

Start date
Dec 1, 2026
Status verified
Dec 2025
Primary completion
Dec 1, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Behavioral Intervention for Physical Activity in MS (BIPAMS)
    A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
  • No Intervention: waitlist control condition
    Participants will have 16-weeks of no intervention or interaction.

Primary Outcome Measure

Change from baseline Sexual Dysfunction at 16 weeks [ Time Frame: Baseline, week 16 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35243-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, AL

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