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Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty

Primary Purpose

Arthroplasty, Replacement, Knee Osteoarthritis

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Walking stick exercise
Sponsored by
National Taipei University of Nursing and Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arthroplasty focused on measuring total knee arthroplasty, Walking stick exercise

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • TAIWAN

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental:Walking stick exercise

Control group: conventional physical therapy.

Arm Description

The experimental: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.

Perform bed mobility and transfers with the least amount of assistance while maintaining appropriate weight bearing (WB) precautions. Ambulate with an assistive device for 25-100 feet and ascend/descend stairs to allow for independence with household activities while maintaining appropriate WB. Verbalize understanding of post-operative activity recommendations/precautions including use of proper positioning of the lower extremity, range of motion and strengthening exercises.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 14, 2021
Last Updated
August 18, 2023
Sponsor
National Taipei University of Nursing and Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05030662
Brief Title
Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty
Official Title
National Taipei University of Nursing and Health Sciences
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
October 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Taipei University of Nursing and Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthroplasty, Replacement, Knee Osteoarthritis
Keywords
total knee arthroplasty, Walking stick exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Sigle,were not involved in the study assessments beyond recording the timed-get-up-and-go test before and after the treatment intervention
Allocation
Randomized
Enrollment
88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental:Walking stick exercise
Arm Type
Experimental
Arm Description
The experimental: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.
Arm Title
Control group: conventional physical therapy.
Arm Type
No Intervention
Arm Description
Perform bed mobility and transfers with the least amount of assistance while maintaining appropriate weight bearing (WB) precautions. Ambulate with an assistive device for 25-100 feet and ascend/descend stairs to allow for independence with household activities while maintaining appropriate WB. Verbalize understanding of post-operative activity recommendations/precautions including use of proper positioning of the lower extremity, range of motion and strengthening exercises.
Intervention Type
Other
Intervention Name(s)
Walking stick exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Total knee arthroplasty of Quality of life
Description
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.
Time Frame
for three months
Secondary Outcome Measure Information:
Title
lower limb muscle power
Description
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.
Time Frame
for three months
Title
knee range of motion
Description
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.
Time Frame
for three months
Other Pre-specified Outcome Measures:
Title
participant characteristics
Description
age, sex, body mass index, job occupation, marriage,Primary caregiver, Exercise habits, BMI % , and education
Time Frame
on the day before surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu Hua Chou
Organizational Affiliation
none,specify Unaffiliated
Official's Role
Principal Investigator
Facility Information:
Facility Name
TAIWAN
City
New Taipei City
ZIP/Postal Code
237
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty

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