Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Change from baseline Sexual Dysfunction at 16 weeks
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Arms & Interventions
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.
Intervention: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS) (Behavioral)
waitlist control condition
Participants will have 16-weeks of no intervention or interaction.
Outcomes
Primary Outcomes
Change from baseline Sexual Dysfunction at 16 weeks
Time Frame: 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 Outcomes
- Change from baseline Sexual Dysfunction in MS at 16 weeks(Baseline, week 16)
- Change from baseline Physical activity at 16 weeks(Baseline, week 16)
- Change from baseline physical activity duration at 16 weeks(Baseline, week 16)
Investigators
Donald Lein
Associate Professor
University of Alabama at Birmingham