- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07696195
The Effectiveness of Resistance Training for Patients With Degenerative Arthritis After Surgery (Arthritis)
The Effectiveness of Resistance Training for Patients With Degenerative Arthritis After Surgery- A Pilot Randomized Controlled Study
Study Overview
Status
Conditions
Detailed Description
This study employed an interventional, experimental design with a three-month follow-up to investigate the effectiveness of a progressive lower extremity resistance training program for patients with osteoarthritis following unilateral total joint arthroplasty. The study adhered to the CONSORT guidelines for reporting clinical trials.
Participants were randomly allocated into two groups:
- Control Group: Received routine postoperative rehabilitation care.
Experimental Group: Received a progressive lower extremity resistance exercise program in addition to routine care. The program utilized 1-kg ankle weights and included seated knee extension, standing hamstring curls, and hip abduction. Training sessions were performed three times per week for three months, with the training volume progressively adjusted as follows:
- 1st Postoperative Month: Performed on the non-operated limb only (2 sets per exercise).
- 2nd Postoperative Month: Continued on the non-operated limb (3 sets) and introduced to the operated limb (2 sets).
- 3rd Postoperative Month: Increased to 4 sets for the non-operated limb and 3 sets for the operated limb.
Each set consisted of 10 repetitions with a 1-minute rest between sets. Participants also received an illustrated exercise leaflet to enhance safety and adherence.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
Taiwan
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Hualien City, Taiwan, Taiwan, 97060
- Hualien Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Inability to ambulate independently
- Medical contraindications to exercise
- Severe musculoskeletal conditions other than osteoarthritis
- Same-day admission and surgery
- Bilateral joint arthroplasty
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental Group
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.
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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.
|
|
Active Comparator: Control Group
Participants received routine postoperative rehabilitation care.
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Participants in the control group received routine postoperative rehabilitation care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lower Extremity Muscle Endurance
Time Frame: 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.
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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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Balance Performance
Time Frame: Shorter completion times (fewer seconds) mean a better outcome (better dynamic balance performance).
|
Assessed using the 2.44-Meter Timed Up-and-Go-Based Chair Rise and Obstacle Navigation Test, which measures the time (in seconds) taken to complete the functional mobility task.
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Shorter completion times (fewer seconds) mean a better outcome (better dynamic balance performance).
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain Intensity
Time Frame: 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.
|
Assessed using the Visual Analog Scale (VAS).
|
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.
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|
quality of life
Time Frame: 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).
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Assessed using the Taiwan version of the World Health Organization Quality of Life-Brief Version (WHOQOL-BREF).
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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).
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB114-014-B
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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