NCT05124522

Brief Summary

The purpose of this study is to implement the person-centered internet-based Health Action Process Approach to promoting physical activity in people with Multiple Sclerosis (i.e., eHAPA-MS online intervention) and assess the intervention's effectiveness and adherence.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable multiple-sclerosis

Timeline
7mo left

Started Oct 2021

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Oct 2021Dec 2026

First Submitted

Initial submission to the registry

October 25, 2021

Completed
Same day until next milestone

Study Start

First participant enrolled

October 25, 2021

Completed
24 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

4.5 years

First QC Date

October 25, 2021

Last Update Submit

August 18, 2025

Conditions

Keywords

Physical ActivityInternet-Based Intervention

Outcome Measures

Primary Outcomes (1)

  • The Health Action Process Approach Battery

    The battery measures risk perception, exercise benefits, motivation, and volition. "change" is being assessed.

    Through study completion, an average of 1 month

Study Arms (2)

MSPA eClass

EXPERIMENTAL
Behavioral: MSPA eClass

Waiting list

NO INTERVENTION

Interventions

MSPA eClassBEHAVIORAL

An 8-week MS-HAPA Internet-based intervention

MSPA eClass

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • are 18 years old and above;
  • any type of multiple sclerosis
  • have not maintained 30 minutes of MVPA accumulated per day for 2 days of the week during the previous 6 months;
  • be relapse-free for the past 30 days;
  • show low risk for contraindications of physical activity indicated by no more than a single 'yes' response on the Physical Activity Readiness Questionnaire;
  • be able to walk with or without an assistive device;
  • are willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period;
  • have a reliable Internet access.

You may not qualify if:

  • have a score \>14 for the leisure score index of the Godin Leisure-Time Exercise Questionnaire;
  • No computer or mobile device access with the internet.
  • Patient determined disease steps (PDDS) Score = 7 i.e., using a wheelchair or scooter most of the time, or PDDS Score = 8 being bedridden.
  • Anyone living outside of the United States of America.
  • Anyone who is unable to speak, read and write in English.
  • not willing to be randomized to an intervention or control group, complete the surveys and questionnaires, and wear an accelerometer during the intervention period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Illinois Urbana-Champaign

Champaign, Illinois, 61820, United States

Location

Related Publications (1)

  • Chiu C, Sridharan V, Khaliji M, Sajib MRUZ, Gao X, Zackowski K. Patient-Centered, Theory-Based, Online Intervention to Promote a Physically Active Lifestyle for People With Multiple Sclerosis: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 Jul 17;14:e66091. doi: 10.2196/66091.

MeSH Terms

Conditions

Multiple SclerosisMotor Activity

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Study Officials

  • Chungyi Chiu, PhD

    University of Illinois Urbana-Champaign

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 25, 2021

First Posted

November 18, 2021

Study Start

October 25, 2021

Primary Completion

April 30, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

The intervention result report.

Shared Documents
CSR
Time Frame
Anticipated December 2025

Locations