Knee OsteoarthritisNCT02928562
The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
A study testing exercise in people with Knee Osteoarthritis and Arthropathy of Knee, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control… Read more about this study
- Who is it for?
- Ages 65 to 85 years
- Conditions the study is for
- Knee Osteoarthritis, Arthropathy of Knee
- What is being tested?
- exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Oct 2013to 31 Oct 2017
- 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 65 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Who cannot join
- The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Sports Medicine Center, Chang Gung Memorial Hospital
Chiayi City, 613
About this study
Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. However, it is still unclear regarding the optimal exercise prescription after TKA. In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients. The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. This project will establish the scientific basis for rehabilitation protocol involving knee surgery.
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Being tested
- 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.
exerciseOther
cyclic exercise, aerobic exercise and resistant training exercise
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | TKA patients without exercise intervention |
| Exercise | Experimental | TKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise ) Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline bone mineral density
Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Secondary outcomes (7)
Change from baseline lower extremity muscle strength
Lower extremity muscle strength, including extension and flexion of the hip, knee and ankle were tested by the HUMAC NORM system (CSMi, Stoughton, MA) with the eccentric/concentric contraction mode at an angular velocity of 60 degrees/s.Isokinetic tests were performed five times for each participant, and each test was separated by a rest period of 3 min. The participants are assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up and received verbal encouragement during the exertion of peak torque.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Motion analysis
Gait analysis by VICON three-dimensional, 8-camera motion capture system.The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline SF-36 questionnaire assessment
SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower score the more disability. The higher the score the less disability. Eight sections including physical function, role limitation due to physical problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. Additionally, the eight health domains can be used to provide a physical component summary and mental component summary score. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline KOOS questionnaire assessment
KOOS contains 5 subscales with a total of 42 items: 1) pain, 2) other symptoms, 3) function in daily living (ADL), 4) function in sport and recreation and 5) knee-related quality of life. Each question receives a score from 0 to 4 and the scores are transformed to a 0-100 score (0, extreme symptoms, 100, no symptoms). The User's Guide, is available from www.koos.nu. The outcome measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---6-minutes' walk test
The 6-minutes' walk test measures the distance an individual is able to walk over a total of 6 minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in 6 minutes and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
Physical fitness---2.44 m up and go
The 2.44 m up and go test indicates the level of the participant's motor agility and dynamic balance and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---30-sec sit to stand
30-sec sit to stand (times in 30sec) is assessed lower body strength, needed for numerous tasks such as climbing stairs, walking and getting out of a chair. Also reduces the chance of falling. Number of full stands that can be completed in 30 seconds with arms folded across chest and is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
Measured: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study start1 Oct 2013
- Primary completion31 Oct 2017
- Study completion31 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Wen-Wei Hsu, Chang Gung Memorial Hospital
- Investigators
- Robert Wen-Wei HSU, MD, Principal investigator, Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928562
- Sponsor's protocol ID
- CORPG6C0021-23
- Status last verified
- Nov 2017
- First submitted
- 18 Sep 2016
- Last updated
- 9 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Hsu WH, Hsu WB, Shen WJ, Lin ZR, Chang SH, Hsu RW. Circuit training enhances function in patients undergoing total knee arthroplasty: a retrospective cohort study. J Orthop Surg Res. 2017 Oct 19;12(1):156. doi: 10.1186/s13018-017-0654-4.
PubMed 29052519
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT02928562
- Acronym / sponsor ID
- CORPG6C0021-23
- Conditions
- Knee Osteoarthritis, Arthropathy of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Oct 2017 (actual)
- Study completion
- 31 Oct 2017 (actual)
- First posted
- 10 Oct 2016 (estimated)
- 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.
Rehabilitation after total knee arthroplasty (TKA) should consider control of postoperative pain and swelling, protection of the healing graft, restoration of full range of motion symmetric to the contralateral knee, strengthening of the muscles that stabilize the knee, hip, and trunk, enhancing neuromuscular control, and a gradual progression to functional activities that are required for return to the normal daily life. The effects of concomitant injuries and surgical procedures must also be considered in planning an individualized rehabilitation program. However, it is still unclear regarding the optimal exercise prescription after TKA. In the current study, the investigators plan to develop an exercise protocol and evaluate the result in a multidisciplinary approach, i.e. bone mineral density assessment. The exercise prescription consisted of cyclic exercise, aerobic exercise and resistant training exercise for first, second and third year, respectively. Cyclic exercise is advantaged safety and effectiveness of hydraulic resistance equipment, as well as the exercise can be quantitatively determined. Aerobic exercise is privileged by the cardiopulmonary endurance improvement, along with muscle strengthening in the associated muscle groups. Resistance exercise is specified for the indicated muscle groups, especially knee extensors, flexors, ankle plantar flexor and dorsi flexor in TKA reconstructed patients. The investigators hypothesis that using this cyclic exercise process can improve the body composition, muscle strength, bone mass density, level of oxidative damage indicators, gait performance, quality of life, knee joint range of motion, function of cardiopulmonary and fitness. This project will establish the scientific basis for rehabilitation protocol involving knee surgery.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –TKA patients without exercise intervention |
| Exercise | Experimental | Other: exerciseTKA patients with exercise intervention ( cyclic exercise, aerobic exercise and resistant training exercise ) |
Who may qualify
- Ages
- 65 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria of this study were the patients diagnosed with serious osteoarthritis (OA) and recommended to receive TKA surgery.
Key exclusion criteria (1 listed)
- The exclusion criteria were the patients with Diabetes, Neuromusculoskeletal disorder, severe chronic disease, history of fracture of a lower limb, artificial limb, and unsuitable for exercise training
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 |
|---|---|---|
| exercisecyclic exercise, aerobic exercise and resistant training exercise | Other | Exercise |
Primary outcome
Change from baseline bone mineral density
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Bone mineral density measurement is measured by dual-energy x-ray absorptiometry (DXA). Measurements are made over the lumbar spine and over the upper part of the hip and the measurement is assessed at pre-operation, three month, six month and nine month after operation, and twelve-month follow-up.
7 secondary outcomes
Change from baseline lower extremity muscle strength
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Motion analysis
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline SF-36 questionnaire assessment
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Change from baseline KOOS questionnaire assessment
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---6-minutes' walk test
Time frame: pre-operation; three month , six month and nine month after operation; twelve-month follow-up
Physical fitness---2.44 m up and go
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Physical fitness---30-sec sit to stand
Time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Derived from this study: PubMed 29052519Hsu WH, Hsu WB, Shen WJ, Lin ZR, Chang SH, Hsu RW. Circuit training enhances function in patients undergoing total knee arthroplasty: a retrospective cohort study. J Orthop Surg Res. 2017 Oct 19;12(1):156. doi: 10.1186/s13018-017-0654-4.
- Individual participant dataSharing planned: Undecided
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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.
Robert Wen-Wei HSU, MD principal investigator
Sports Medicine Center, Chang Gung Memorial Hospital, Chiayi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing exercise in people with Knee Osteoarthritis and Arthropathy of Knee, run by Chang Gung Memorial Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 9 Nov 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline bone mineral density (time frame: pre-operation; three month ; six month and nine month after operation; twelve-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928562, which also lists 1 linked publication.
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 9 Nov 2017.