Menu
Not yet recruiting NCT04768777

Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

No phase Interventional Multiple Sclerosis, Relapsing-Remitting Sexual Dysfunction

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Behavioural intervention for physical activity for multiple sclerosis (BIPAMS).
Who it may be relevant to
Registry conditions: Multiple Sclerosis, Relapsing-Remitting, Sexual Dysfunction. Basic parameters: 18 years — 45 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Behavioral Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)
    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 rel

Primary outcome measures

  • Change from baseline Sexual Dysfunction at 16 weeks [Time frame: Baseline, week 16]
Secondary outcome measures (3)
  • Change from baseline Sexual Dysfunction in MS at 16 weeks [Time frame: Baseline, week 16]
  • Change from baseline Physical activity at 16 weeks [Time frame: Baseline, week 16]
  • Change from baseline physical activity duration at 16 weeks [Time frame: Baseline, week 16]

Eligibility criteria

Inclusion criteria

  • Female
  • 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

\-

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • University of Alabama at Birmingham — Birmingham

Identifiers

NCT: NCT04768777 · IRB-300006813

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗