Behavioral Intervention for Physical Activity and Sexual Dysfunction in Multiple Sclerosis

NCT04768777 | Not Yet Recruiting

• 1 other identifier: IRB-300006813
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction

Keywords

physical activity; sexual behaviour

Outcome Measures

Primary Outcomes (1)

• Change from baseline Sexual Dysfunction at 16 weeks

  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.

  Baseline, week 16

Secondary Outcomes (3)

• 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

Other Outcomes (8)

• Stability and changes of Fatigue over time

  Baseline, week 16

• Change from Baseline Depression at 16 weeks

  Baseline, week 16

• Change from Baseline Anxiety at 16 weeks

  Baseline, week 16

Study Arms (2)

Behavioral Intervention for Physical Activity in MS (BIPAMS)

EXPERIMENTAL

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

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

waitlist control condition

NO INTERVENTION

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

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.

Behavioral Intervention for Physical Activity in MS (BIPAMS)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• National Multiple Sclerosis Society: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35243, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting; Sexual Dysfunction, Physiological; Motor Activity; Coitus

Interventions

Exercise

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Genital Diseases; Urogenital Diseases; Behavior; Sexual Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Donald Lein, PhD

CONTACT

2059340241; dlein@uab.edu

Ashlie Ithurburn

CONTACT

2059751306; akji@uab.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 10, 2021
• First Posted: February 24, 2021
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

US (1)