NCT07696195

Brief Summary

Osteoarthritis is a common degenerative disease that significantly impacts mobility and disability in older adults. This pilot randomized controlled study aimed to examine the effects of a three-month resistance training program on lower limb muscular endurance, balance performance, pain, and quality of life among patients who had undergone unilateral total knee arthroplasty. Twenty-four participants were randomly assigned to either the experimental group receiving resistance training or the control group receiving routine postoperative rehabilitation. The study evaluates and compares the effectiveness of these interventions to provide insights into incorporating resistance training into postoperative nursing care and recovery programs.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 22, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 1, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2026

Completed
Last Updated

July 10, 2026

Status Verified

July 1, 2026

Enrollment Period

3 months

First QC Date

July 1, 2026

Last Update Submit

July 8, 2026

Conditions

Keywords

Resistance TrainingTotal Knee ArthroplastyPostoperative RehabilitationMuscular EnduranceBalance Performance

Outcome Measures

Primary Outcomes (1)

  • Lower Extremity Muscle Endurance

    Assessed using the 30-Second Chair Stand Test. This test measures the total number of completed stands a participant can perform from a seated position to a full stand within 30 seconds.

    A higher number of completed stands means a better outcome (better lower extremity muscular endurance). To ensure safety for postoperative patients, a four-legged walker is placed in front of the chair during testing.

Secondary Outcomes (1)

  • Balance Performance

    Shorter completion times (fewer seconds) mean a better outcome (better dynamic balance performance).

Other Outcomes (2)

  • Pain Intensity

    The score ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores mean a worse outcome (greater pain intensity). All assessments are conducted by the same researcher to ensure consistency.

  • quality of life

    This 28-item instrument covers physical health, psychological well-being, social relationships, and environmental factors. The total score ranges from 28 to 112 ,Higher scores mean a better outcome (better perceived quality of life).

Study Arms (2)

Experimental Group

EXPERIMENTAL

Participants received a progressive lower extremity resistance exercise program using 1-kg ankle weights (including seated knee extension, standing hamstring curls, and hip abduction) 3 times per week for 3 months, in addition to routine postoperative care.

Behavioral: Progressive Lower Extremity Resistance Exercise

Control Group

ACTIVE COMPARATOR

Participants received routine postoperative rehabilitation care.

Behavioral: Routine Postoperative Rehabilitation Care

Interventions

A 3-month progressive resistance training program utilizing 1-kg ankle weights, including seated knee extension, standing hamstring curls, and hip abduction. Training sessions were performed 3 times per week, with progressive adjustments in training volume (sets and repetitions) for both operated and non-operated limbs over the 3-month period.

Experimental Group

Participants in the control group received routine postoperative rehabilitation care.

Control Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of osteoarthritis requiring first-time unilateral lower limb total joint arthroplasty
  • No planned surgery on the contralateral limb
  • Clear consciousness and ability to communicate in Mandarin or Taiwanese
  • Independent ambulation before surgery
  • Adequate vision and hearing (with correction if needed)
  • Community-dwelling status
  • Willing to participate in this study

You may not qualify if:

  • Inability to ambulate independently
  • Medical contraindications to exercise
  • Severe musculoskeletal conditions other than osteoarthritis
  • Same-day admission and surgery
  • Bilateral joint arthroplasty

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation

Hualien City, Taiwan, 97060, Taiwan

Location

MeSH Terms

Conditions

OsteoarthritisOsteoarthritis, Knee

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

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

July 1, 2026

First Posted

July 10, 2026

Study Start

March 1, 2025

Primary Completion

May 22, 2025

Study Completion

August 19, 2025

Last Updated

July 10, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations