NCT05289544

Brief Summary

The objective of this study is to examine the short-term (6-weeks and 6 months) and long-term (1 year) effects of a phone-based version of Walk With Ease intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
267

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 21, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 10, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 10, 2024

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 6, 2026

Completed
Last Updated

March 6, 2026

Status Verified

February 1, 2026

Enrollment Period

2.4 years

First QC Date

March 11, 2022

Results QC Date

August 26, 2025

Last Update Submit

February 13, 2026

Conditions

ArthritisGoutFibromyalgiaRheumatoid ArthritisOsteoarthritisLupus Erythematosus, Systemic

Keywords

ArthritisPhysical activityIntervention

Outcome Measures

Primary Outcomes (9)

  • Change in Pain

    Visual analog scale (0mm no/low pain to 100 mm high pain)

    Baseline to 6 weeks

  • Change in Pain

    Visual analog scale (0mm no/low pain to 100 mm high pain)

    Baseline to 6 months

  • Change in Pain

    Visual analog scale (0mm no/low pain to 100 mm high pain)

    Baseline to 12 months

  • Change in Physical Function - Chair Stands

    repetitions completed during 30 second chair stand test

    Baseline to 6 weeks

  • Change in Physical Function - Chair Stands

    repetitions completed during 30 second chair stand test

    Baseline to 6 months

  • Change in Physical Function - Chair Stands

    repetitions completed during 30 second chair stand test

    Baseline to 12 months

  • Change in Physical Function - 6 Minute Walk

    Distance walked (ft) during 6 minute walk test

    Baseline to 6 weeks

  • Change in Physical Function - 6 Minute Walk

    Distance walked (ft) during 6 minute walk test

    Baseline to 6 months

  • Change in Physical Function - 6 Minute Walk

    Distance walked (ft) during 6 minute walk test

    Baseline to 12 months

Secondary Outcomes (12)

  • Change in Physical Limitations

    Baseline to 6 weeks

  • Change in Physical Limitations

    Baseline to 6 months

  • Change in Physical Limitations

    Baseline to 12 months

  • Change in Physical Activity

    Baseline to 6 weeks

  • Change in Physical Activity

    Baseline to 6 months

  • +7 more secondary outcomes

Study Arms (2)

Phone-Based Walk With Ease Program

EXPERIMENTAL

Telephone-based Walk With Ease Program adapted from the Arthritis Foundations program

Behavioral: Phone-Based Walk With Ease

Delayed Phone-Based Walk With Ease Program

OTHER

Telephone-Based Walk With Ease Program starting after the 1 year assessment

Behavioral: Phone-Based Walk With Ease

Interventions

Phone-Based Walk With EaseBEHAVIORAL

6 week phone-delivered Walk With Ease Program

Delayed Phone-Based Walk With Ease ProgramPhone-Based Walk With Ease Program

Eligibility Criteria

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

You may qualify if:

  • told by a doctor or other health professional that you have some form of arthritis, rheumatoid arthritis, gout, lupus, fibromyalgia
  • able to read and write in English
  • plan to live in the Columbia, SC region for next year
  • willing to be randomized to either group
  • complete all baseline measure

You may not qualify if:

  • contraindications to exercise (besides arthritis)
  • are pregnant, breastfeeding, or planning to become pregnant in the next year
  • have a serious cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

Related Links

MeSH Terms

Conditions

ArthritisGoutFibromyalgiaArthritis, RheumatoidOsteoarthritisLupus Erythematosus, SystemicMotor Activity

Interventions

methyl hydroxyethyl cellulose

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic DiseasesMuscular DiseasesNeuromuscular DiseasesNervous System DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Results Point of Contact

Title
Christine Pellegrini
Organization
University of South Carolina
pellegca@mailbox.sc.edu
803-777-0911

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 11, 2022

First Posted

March 21, 2022

Study Start

April 1, 2022

Primary Completion

September 10, 2024

Study Completion

September 10, 2024

Last Updated

March 6, 2026

Results First Posted

March 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

De-identified data will be made available within 30 months of the completion of the project.

Shared Documents
STUDY PROTOCOL, ICF
Time Frame
Data will be made available within 30 months of the completion of the project.
Access Criteria
open access

Locations

US(1)