NCT05030662

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 1, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 21, 2023

Status Verified

August 1, 2023

Enrollment Period

10 months

First QC Date

August 14, 2021

Last Update Submit

August 18, 2023

Conditions

Keywords

total knee arthroplastyWalking stick exercise

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • lower limb muscle power

    for three months

  • knee range of motion

    for three months

Other Outcomes (1)

  • participant characteristics

    on the day before surgery

Study Arms (2)

Experimental:Walking stick exercise

EXPERIMENTAL

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

Control group: conventional physical therapy.

NO INTERVENTION

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.

Interventions

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.

Experimental:Walking stick exercise

Eligibility Criteria

Age60 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 60 and 85 years
  • Informed consent
  • Receipt of elective unilateral primary knee arthroplasty surgery.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

TAIWAN

New Taipei City, 237, Taiwan

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yu Hua Chou

    none,specify Unaffiliated

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Sigle,were not involved in the study assessments beyond recording the timed-get-up-and-go test before and after the treatment intervention
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 14, 2021

First Posted

September 1, 2021

Study Start

August 1, 2021

Primary Completion

May 31, 2022

Study Completion

October 31, 2023

Last Updated

August 21, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations