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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05030662
Other study ID # YChou
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date August 1, 2021
Est. completion date October 31, 2023

Study information

Verified date August 2023
Source National Taipei University of Nursing and Health Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 88
Est. completion date October 31, 2023
Est. primary completion date May 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 60 Years to 85 Years
Eligibility 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 Design


Intervention

Other:
Walking stick exercise
Education of walking stick exercise by research nurses twice before discharge (on the day before surgery and before discharge) The video clip of "walking stick exercise" is available to the patients. The research nurses encourage our patients to keep rehabilitation by phone calls once a week after discharge.

Locations

Country Name City State
Taiwan TAIWAN New Taipei City

Sponsors (1)

Lead Sponsor Collaborator
National Taipei University of Nursing and Health Sciences

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other participant characteristics age, sex, body mass index, job occupation, marriage,Primary caregiver, Exercise habits, BMI % , and education on the day before surgery
Primary Total knee arthroplasty of Quality of life 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 lower limb muscle power 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
Secondary knee range of motion 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
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