NCT07804212

Brief Summary

This study aims to investigate the effectiveness of an intervention combining strength training and self-management education in improving symptoms, sleep quality, emotional well-being, and quality of life in patients with knee osteoarthritis. This study employs a quasi-experimental design. Participants diagnosed with knee osteoarthritis were recruited from the outpatient orthopedics and rehabilitation departments of a public regional teaching hospital in southern Taiwan. They were randomly assigned to either an experimental group (n = 50) or a control group (n = 50). Due to the nature of the intervention, blinding was not feasible, and participants were aware of their group assignment. The experimental group also participated in a home-based strength training program, while the control group received conventional osteoarthritis routine care. Data were collected at baseline, one month, and three months post-intervention during follow-up appointments.

Trial Health

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Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
7mo left

Started Oct 2026

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

Study Progress2%
Oct 2026May 2027

First Submitted

Initial submission to the registry

August 10, 2026

Completed
25 days until next milestone

First Posted

Study publicly available on registry

September 4, 2026

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2026

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2027

Last Updated

September 24, 2026

Status Verified

May 1, 2026

Enrollment Period

7 months

First QC Date

August 10, 2026

Last Update Submit

September 21, 2026

Conditions

Keywords

strength trainingself-managementknee osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Emotional well-being measured by the HADS

    The HADS consists of anxiety and depression subscales, each with seven items and a maximum score of 21; higher scores indicate greater symptom severity.

    Baseline, 1 month, and 2 months

  • Sleep quality measured by the PSQ

    The PSQI comprises seven components: subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbance, use of sleep medication, and daytime dysfunction. Scores range from 0 to 21, with higher scores indicating poorer sleep quality.

    Baseline, 1 month, and 2 months

  • Quality of life measured by the EQ-5D-3L

    EQ-5D-3L comprises two components: (1) the EQ-5D health index. A maximum total score of 15; lower scores indicate better health-related quality of life. (2) EQ-VAS uses a visual analog scale with a maximum score of 100.

    Baseline, 1 month, and 2 months

  • OA symptoms measured by the WOMAC

    WOMAC: The Mandarin Chinese version uses a 100-mm visual analog scale, with ends representing opposite symptoms like "no pain" to "very painful," "no stiffness" to "very stiff," and "no difficulty" to "very difficult." Scores range from 0 to 100 per question, with pain up to 500, stiffness up to 200, and activity up to 1700 points.

    Baseline, 1 month, and 2 months

Study Arms (2)

Strength Training Group

EXPERIMENTAL

A structured home-based strength training program consisting of knee endurance exercises, sit-to-stand transitions, walking, and range-of-motion (ROM) exercises. The intervention is performed three times per week for 8 weeks. To ensure exercise fidelity and safety, the 'teach-back' method is utilized during initial instruction, and participants maintain a daily exercise log to monitor compliance.

Other: Strength Training

conventional osteoarthritis routine care

OTHER

The group will receive conventional osteoarthritis routine care. Follow-up assessments will be conducted during the second clinic visit (1 month post-enrollment) and the third clinic visit (2 months post-enrollment).

Other: Strength Training

Interventions

A structured home-based strength training program consisting of knee endurance exercises, sit-to-stand transitions, walking, and range-of-motion (ROM) exercises. The intervention is performed three times per week for 8 weeks. To ensure exercise fidelity and safety, the 'teach-back' method is utilized during initial instruction, and participants maintain a daily exercise log to monitor compliance.

Strength Training Groupconventional osteoarthritis routine care

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45 or older
  • Diagnosed with symptomatic knee osteoarthritis by a physician
  • Normal hearing and able to communicate effectively

You may not qualify if:

  • Severe inflammatory arthritis
  • Pending or previous unilateral or bilateral total knee replacement
  • Contraindications to exercise therapy
  • Received physical therapy or knee injections in the past month
  • Psychiatric or cognitive impairments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fooyin University

Kaohsiung City, Taiwan (r.o.c.), 831301, Taiwan

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Ching-Ju Chen, PhD

CONTACT

Study Design

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

Study Record Dates

First Submitted

August 10, 2026

First Posted

September 4, 2026

Study Start

October 1, 2026

Primary Completion (Estimated)

May 11, 2027

Study Completion (Estimated)

May 11, 2027

Last Updated

September 24, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

IPD that underlies the results in a publication.

Locations