Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis (BIPAMS-SD)

The University of Alabama at Birmingham

Status: Begins enrollment in 9 months

Conditions: Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction

Treatments: Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT04768777

IRB-300006813

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

    -

    Exclusion Criteria:

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

-

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Behavioral Intervention for Physical Activity in MS (BIPAMS)

Experimental group

Description:

A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.

Treatment:

Behavioral: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)

waitlist control condition

No Intervention group

Description:

Participants will have 16-weeks of no intervention or interaction.