NCT07246811

Brief Summary

This is a single-center, randomized, parallel-controlled trial evaluating the efficacy and safety of an artificial intelligence-based exercise prescription system for rehabilitation in rheumatoid arthritis (RA) patients. A total of 147 patients with low-to-moderate disease activity will be randomly assigned to three groups: AI exercise prescription group (personalized AI system guidance), paper exercise prescription group (traditional paper guidance), and routine care group. The intervention will last for 6 weeks with 6-month follow-up assessments evaluating joint function, pain, and quality of life indicators.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
147

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 24, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

November 30, 2025

Completed
15 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
Last Updated

November 24, 2025

Status Verified

August 1, 2025

Enrollment Period

15 days

First QC Date

August 11, 2025

Last Update Submit

November 20, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Knee flexion range of motion

    Knee Flexion Range of Motion Unit of Measure: Degrees (°) Knee flexion range of motion refers to the maximum angle through which the knee joint can bend, measured from the straight (extended) position to the farthest point the lower leg can move toward the thigh. This assessment evaluates the flexibility and functional mobility of the knee, which is critical for daily activities such as walking, climbing stairs, and sitting. Relevant definitions and criteria: A "normal" range of motion for knee flexion in adults is generally considered to be 135° to 150°, though this can vary slightly based on age, physical conditioning, and individual anatomy. Limited knee flexion (e.g., less than 90°) may indicate joint stiffness, muscle tightness, or underlying issues such as injury, arthritis, or post-surgical scarring.

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

Secondary Outcomes (12)

  • Hospital for Special Surgery (HSS) Score

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  • Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  • Timed Up and Go (TUG) Test

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  • Berg Balance Scale (BBS)

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  • Isokinetic Muscle Strength Test

    Baseline, post-intervention (6 weeks), 3-month follow-up, 6-month follow-up

  • +7 more secondary outcomes

Study Arms (3)

Routine Care Group

ACTIVE COMPARATOR

Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.

Other: education and basic joint mobility exercises

Paper Exercise Prescription Group

ACTIVE COMPARATOR

Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching.

Other: paper-based exercise prescription

AI Exercise Prescription Group

EXPERIMENTAL

Uses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback.

Other: AI Exercise Prescription

Interventions

Uses "Yidong Health AI Exercise Prescription System" delivered via WeChat mini-program, providing personalized exercise prescriptions (three sets: A/B/C) with AI Q\&A module. Physicians adjust prescriptions weekly based on patient feedback.

AI Exercise Prescription Group

Receives standardized RA disease management education and basic joint mobility exercises provided by rheumatology nurses.

Routine Care Group

Receives paper-based exercise prescription developed by rehabilitation therapists, including warm-up, formal training (bridging, modified bird-dog exercise, etc.) and cool-down stretching.

Paper Exercise Prescription Group

Eligibility Criteria

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

You may qualify if:

  • Age ≥18 years Meets 2010 ACR/EULAR classification criteria for RA Low-to-moderate disease activity (assessed by rheumatologist) Knee joint involvement Willing and able to provide informed consent

You may not qualify if:

  • Existing joint ankylosis (fibrous or bony) Acute flare or extra-articular soft tissue lesions Comorbid with other rheumatic diseases (e.g., SLE, Sjögren's syndrome) Severe hepatic or renal impairment Knee joint VAS pain score \>4 (0-10 scale) Psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Rehabilitation Medicine, Peking University People's Hospital

Beijing, Beijing Municipality, 100000, China

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Educational Status

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Socioeconomic FactorsPopulation Characteristics

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2025

First Posted

November 24, 2025

Study Start

November 30, 2025

Primary Completion

December 15, 2025

Study Completion

March 15, 2026

Last Updated

November 24, 2025

Record last verified: 2025-08

Locations