- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05030662
Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty
August 18, 2023 updated by: Yu Hua Chou, National Taipei University of Nursing and Health Sciences
National Taipei University of Nursing and Health Sciences
The purpose of this study is to examine whether the effect of "hiking poles exercise" on lower extremity muscular strength, knee range of motion, and quality of life in elderly patients underwent total knee arthroplasty
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
Detailed Description
This is a longitudinal-experimental study.
The data collection and analysis are in a single-blind manner.
The study will be undertaken in the Department Orthopaedics of En Chu Kong hospital (approximate 500-bed regional teaching hospital).
All patients who meet the inclusion criteria are admitted for primary total knee arthroplasty and assigned to control group or intervention group randomly.
The 44 patients in the control group received routine guidance of " Rehabilitation and precautions for artificial knee replacement ".
In addition to the routine guidance, the 44 patients in the intervention group received educations of " hiking poles exercise " on the day before surgery and before discharge, as well as a follow-up call at least once a week after discharge.
Study Type
Interventional
Enrollment (Estimated)
88
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
New Taipei City, Taiwan, 237
- Taiwan
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Minimum Age: 60 years Maximum Age: 85years Gender-Based: All Accepts Healthy Volunteers:No
Criteria:
Inclusion Criteria:
- Age between 60 and 85 years
- Informed consent
- Receipt of elective unilateral primary knee arthroplasty surgery.
Exclusion Criteria:
- Non-degenerative arthritis, including rheumatoid arthritis, or traumatic arthritis
- Patients receiving rehabilitation simultaneously
- Patients with other musculoskeletal or neurological problems, including fractures, Parkinsonism, cerebrovascular events, or patients with multiple comorbidities
- Cancer patients receive chemotherapy
- Patients with the peri-operative complication that has an adverse effect on outcomes,for example: intra-operative fractures, thromboembolism, peri-operative infections, or phlebitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Experimental:Walking stick exercise
The experimental:Walking stick exercise
|
|
|
No Intervention: Control group: conventional physical therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total knee arthroplasty of Quality of life
Time Frame: for three months
|
I hope the Walking stick exercise can to improving the total knee arthroplasty quality of life of patients.
I use Knee injury and Osteoarthritis Outcome Score (KOOS).
There are 5 territories analyzed in the knee injury and osteoarthritis outcome score (KOOS) calculator and a knee-related QOL, Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopedic scales and generic measures.
Scores between 0 and 100 represent the percentage of the total possible score achieved.
Furthermore, I will follow up to study on the day before surgery at 1, 6, and 12 weeks post-surgery.
|
for three months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
lower limb muscle power
Time Frame: for three months
|
I hope the Walking stick exercise can to improving the total knee arthroplasty lower limb muscle power.
I use include 30-second chair stand test.
Furthermore, I will follow up to study on the day before surgery at 1, 6, and 12 weeks post-surgery.
|
for three months
|
|
knee range of motion
Time Frame: for three months
|
I hope the Walking stick exercise can to improving the total knee arthroplasty lower limb muscle power.
I use include 30-second chair stand test.
Furthermore, I will follow up to study on the day before surgery at 1, 6, and 12 weeks post-surgery.
|
for three months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
participant characteristics
Time Frame: on the day before surgery
|
age, sex, body mass index, job occupation, marriage,Primary caregiver, Exercise habits, BMI % , and education
|
on the day before surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yu Hua Chou, none,specify Unaffiliated
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2021
Primary Completion (Actual)
May 31, 2022
Study Completion (Estimated)
October 31, 2023
Study Registration Dates
First Submitted
August 14, 2021
First Submitted That Met QC Criteria
August 31, 2021
First Posted (Actual)
September 1, 2021
Study Record Updates
Last Update Posted (Actual)
August 21, 2023
Last Update Submitted That Met QC Criteria
August 18, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- YChou
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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