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

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
88

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Taiwan
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental:Walking stick exercise

The experimental:Walking stick exercise

  1. Education of walking stick exercise by research nurses twice before discharge (on the day before surgery and before discharge)
  2. The video clip of "walking stick exercise" is available to the patients.
  3. The research nurses encourage our patients to keep rehabilitation by phone calls once a week after discharge.
Other: Walking stick exercise
  1. Education of walking stick exercise by research nurses twice before discharge (on the day before surgery and before discharge)
  2. The video clip of "walking stick exercise" is available to the patients.
  3. The research nurses encourage our patients to keep rehabilitation by phone calls once a week after discharge.
No Intervention: Control group: conventional physical therapy.
  1. Perform bed mobility and transfers with the least amount of assistance while maintaining appropriate weight bearing (WB) precautions.
  2. Ambulate with an assistive device for 25-100 feet and ascend/descend stairs to allow for independence with household activities while maintaining appropriate WB.
  3. Verbalize understanding of post-operative activity recommendations/precautions including use of proper positioning of the lower extremity, range of motion and strengthening exercises.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National Taipei University of Nursing and Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2022

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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