ArthroplastyNCT05030662
Walking Stick Exercise in Patients Underwent Total Knee Arthroplasty
A study testing Walking stick exercise in people with Arthroplasty and Replacement, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
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 Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Arthroplasty, Replacement, Knee Osteoarthritis
- What is being tested?
- Walking stick exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2021to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 60 and 85 years
- Informed consent
- Receipt of elective unilateral primary knee arthroplasty surgery.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Arthroplasty, Replacement, Knee Osteoarthritis
- Being tested
- Walking stick exercise
- Keywords
- total knee arthroplasty, Walking stick exercise
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking stick exerciseOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: for three months
Secondary outcomes (2)
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.
Measured: for three months
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.
Measured: for three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start1 Aug 2021
- Primary completion31 May 2022
- Study completion31 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taipei University of Nursing and Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu Hua Chou, National Taipei University of Nursing and Health Sciences
- Investigators
- Yu Hua Chou, Principal investigator, none,specify Unaffiliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030662
- Sponsor's protocol ID
- YChou
- Status last verified
- Aug 2023
- First submitted
- 14 Aug 2021
- Last updated
- 21 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Taipei University of Nursing and Health Sciences
- ClinicalTrials.gov ID
- NCT05030662
- Acronym / sponsor ID
- YChou
- Conditions
- Arthroplasty, Replacement, Knee Osteoarthritis
- Keywords
- total knee arthroplasty, Walking stick exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- National Taipei University of Nursing and Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 Oct 2023 (estimated)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental:Walking stick exercise | Experimental | Other: Walking stick exerciseThe 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. |
| 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. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 60 and 85 years
- Informed consent
- Receipt of elective unilateral primary knee arthroplasty surgery.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking stick exercise1. 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 | Experimental:Walking stick exercise |
Primary outcome
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.
2 secondary outcomes
lower limb muscle power
Time frame: for three months
knee range of motion
Time frame: for three months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Hua Chou principal investigator
none,specify Unaffiliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking stick exercise in people with Arthroplasty and Replacement, run by National Taipei University of Nursing and Health Sciences at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total knee arthroplasty of Quality of life (time frame: for three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2023.