Total Knee ReplacementNCT05137028
Otago Exercise in Patient With Total Knee Replacement
A study testing Otago Exercise in people with Total Knee Replacement, run by Riphah International University at 1 site in Pakistan.
Trial summary
To determine the effect of Otago exercise in Total Knee Replacement Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Replacement
- What is being tested?
- Otago Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 sitePakistan
- Study dates
- 13 Nov 2021to 11 May 2022
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to participate
- Participants who undergo unilateral cemented knee replacement due to arthritis
Who cannot join
- Uncontrolled Hypertension
- Lower extremity impairment that can limit the patient's function
- Patient with neurological and cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Otago Exercise on Balance and Mobility in Patient With Total Knee Replacement
To determine the effect of Otago exercise in Total Knee Replacement
Read the detailed description
Degenerative knee arthritis is one of the most common diseases in the elderly population. Age is the strongest risk factor for osteoarthritis. The 2010 Global Burden of Disease Study reports that the burden of musculoskeletal disorders is much larger than estimated in previous assessments and accounts for 6.8% of daily worldwide. An estimated 10% to 15% of all adults aged over 60 have some degree of OA. In Pakistan, 3.6% in rural and 3.1-4.6% in urban parts of Pakistan were found diagnosed by knee OA.
When conservative treatments fail to control the symptoms, joint replacement is performed. Specifically, more than 1 million surgeries are performed every year in the United States (US) alone, with a total expenditure close to 13.7 billion and 28.5 billion US dollars for the hips and knees, respectively. The demand is expected to increase by approximately 4 time by the year 2030 annually more than 4000 joint have been replaced in Pakistan." Overall, the progress of patients after joint replacement is satisfactory. Nevertheless, a substantial number may present with functional and balance limitations, even 1 year after surgery.
A cross sectional study reported that a Home-based balance and strength exercises (OEP) benefited older fallers with OA and gait and balance disorders by improving postural control. Another study has been done which suggested that elderly people who performed the OEP showed an increase in balance, muscle strength, and a decrease in both fall percentage and fall frequency. Evidence has recommended that, the OEP was more effective improving functional balance, muscle strength and physical health.
A cross sectional study was conducted to evaluate the influence of specific balance-targeted training on the overall state of balance in older adults undergoing TKR. They concluded that the additional balance training program improved balance performance to a higher extent than a control group.
After surgery, pain and stiffness are remarkably relieved, but functional and proprioceptive deficits, including limitation of lower limb mobility, difficulties in walking, and alterations instability and balance may remain. However, the effect of Otago exercise on balance are present in literature but the evidence for their influence in patients with TKR is narrow. So aim of this study to identify the possible role of Otago exercise program in particular population (TKR) and the prognosis in balance and Gait with this protocol in patients undergoing TKR.
- Conditions
- Total Knee Replacement
- Being tested
- Otago Exercise
- Keywords
- Balance training, Total knee replacement, Otago exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Otago ExerciseOther
Otago exercise protocol
Strengthening exercise:
Resistance exercise for knee flexors, knee extensors, hip abductor, ankle dorsiflexors, ankle planterflexors
Balance exercise:
knee bending, backward walking, walking and turning around, sideway walking, tendem stance, tendem walking, one leg stand, heel walking, toe walking, heel to toe walking, sit to stand, stair walking
| Study group | Role | What they receive |
|---|---|---|
| Otago Exercise | Experimental | Otago Exercise Group Receives: Other: Otago Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Functional Reach test
The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. It ranges 6-10 inches greater than 10 inches indicate low risk of fall as lower than 6 inches has higher risk of fall.
Measured: 24 weeks
Timed Up and Go (TUG) Test
Measure of function with correlates to balance and fall risk. Less than 10 seconds for this task means normal while greater seconds mean higher risk of fall
Measured: 24 weeks
Single leg Stance (SLS) Test
The Single leg Stance (SLS) Test is used to assess static postural and balance control. Single leg stance more than 10 seconds is normal. Less than 5 seconds indicate higher risk of fall.
Measured: 24 weeks
Stair Climbing Test
Stair climbing test is used to assess Functional strength, balance and agility through ascending and descending a set number of steps. 5 minutes for 9 step of stairs means normal while more than 5 minutes for 9 step of stairs indicate risk of fall.
Measured: 24 weeks
Balance and Gait App
This app will use to assess the balance and gait. It has 4 competent 2 for static and 2 for dynamic. For static patient will stand for eyes open and close, and for dynamic patient will walk for 3 meter with and without head movement. Maximum time for each task is 30 seconds. For dynamic balance the average range for this age groups is 60-67 lower than this indicate higher risk of fall.
Measured: 24 weeks
Numerical Pain Rating Scale
Numeric Pain Rating Scale NPRS measure of the intensity of pain. Numerical pain rating scores is 0-10. 0 means no pain while 10 means worse pain.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2021
- Study start13 Nov 2021
- Primary completion11 May 2022
- Study completion11 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ReplacementStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD*, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05137028
- Sponsor's protocol ID
- REC/01042 Allena Javed
- Status last verified
- Jan 2023
- First submitted
- 18 Nov 2021
- Last updated
- 17 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Otago Exercise on Balance and Mobility in Patient With Total Knee Replacement
- ClinicalTrials.gov ID
- NCT05137028
- Acronym / sponsor ID
- REC/01042 Allena Javed
- Conditions
- Total Knee Replacement
- Keywords
- Balance training, Total knee replacement, Otago exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 13 Nov 2021 (actual)
- Primary completion
- 11 May 2022 (actual)
- Study completion
- 11 May 2022 (actual)
- First posted
- 30 Nov 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.
To determine the effect of Otago exercise in Total Knee Replacement
Detailed description
Degenerative knee arthritis is one of the most common diseases in the elderly population. Age is the strongest risk factor for osteoarthritis. The 2010 Global Burden of Disease Study reports that the burden of musculoskeletal disorders is much larger than estimated in previous assessments and accounts for 6.8% of daily worldwide. An estimated 10% to 15% of all adults aged over 60 have some degree of OA. In Pakistan, 3.6% in rural and 3.1-4.6% in urban parts of Pakistan were found diagnosed by knee OA.
When conservative treatments fail to control the symptoms, joint replacement is performed. Specifically, more than 1 million surgeries are performed every year in the United States (US) alone, with a total expenditure close to 13.7 billion and 28.5 billion US dollars for the hips and knees, respectively. The demand is expected to increase by approximately 4 time by the year 2030 annually more than 4000 joint have been replaced in Pakistan." Overall, the progress of patients after joint replacement is satisfactory. Nevertheless, a substantial number may present with functional and balance limitations, even 1 year after surgery.
A cross sectional study reported that a Home-based balance and strength exercises (OEP) benefited older fallers with OA and gait and balance disorders by improving postural control. Another study has been done which suggested that elderly people who performed the OEP showed an increase in balance, muscle strength, and a decrease in both fall percentage and fall frequency. Evidence has recommended that, the OEP was more effective improving functional balance, muscle strength and physical health.
A cross sectional study was conducted to evaluate the influence of specific balance-targeted training on the overall state of balance in older adults undergoing TKR. They concluded that the additional balance training program improved balance performance to a higher extent than a control group.
After surgery, pain and stiffness are remarkably relieved, but functional and proprioceptive deficits, including limitation of lower limb mobility, difficulties in walking, and alterations instability and balance may remain. However, the effect of Otago exercise on balance are present in literature but the evidence for their influence in patients with TKR is narrow. So aim of this study to identify the possible role of Otago exercise program in particular population (TKR) and the prognosis in balance and Gait with this protocol in patients undergoing TKR.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Otago Exercise | Experimental | Other: Otago ExerciseOtago Exercise Group |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Willing to participate
- Participants who undergo unilateral cemented knee replacement due to arthritis
Key exclusion criteria (3 listed)
- Uncontrolled Hypertension
- Lower extremity impairment that can limit the patient's function
- Patient with neurological and cognitive impairment
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 |
|---|---|---|
| Otago ExerciseOtago exercise protocol Strengthening exercise: Resistance exercise for knee flexors, knee extensors, hip abductor, ankle dorsiflexors, ankle planterflexors Balance exercise: knee bending, backward walking, walking and turning around, sideway walking, tendem stance, tendem walking, one leg stand, heel walking, toe walking, heel to toe walking, sit to stand, stair walking | Other | Otago Exercise |
Primary outcome
The Functional Reach test
Time frame: 24 weeks
The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. It ranges 6-10 inches greater than 10 inches indicate low risk of fall as lower than 6 inches has higher risk of fall.
Timed Up and Go (TUG) Test
Time frame: 24 weeks
Measure of function with correlates to balance and fall risk. Less than 10 seconds for this task means normal while greater seconds mean higher risk of fall
Single leg Stance (SLS) Test
Time frame: 24 weeks
The Single leg Stance (SLS) Test is used to assess static postural and balance control. Single leg stance more than 10 seconds is normal. Less than 5 seconds indicate higher risk of fall.
Stair Climbing Test
Time frame: 24 weeks
Stair climbing test is used to assess Functional strength, balance and agility through ascending and descending a set number of steps. 5 minutes for 9 step of stairs means normal while more than 5 minutes for 9 step of stairs indicate risk of fall.
Balance and Gait App
Time frame: 24 weeks
This app will use to assess the balance and gait. It has 4 competent 2 for static and 2 for dynamic. For static patient will stand for eyes open and close, and for dynamic patient will walk for 3 meter with and without head movement. Maximum time for each task is 30 seconds. For dynamic balance the average range for this age groups is 60-67 lower than this indicate higher risk of fall.
Numerical Pain Rating Scale
Time frame: 24 weeks
Numeric Pain Rating Scale NPRS measure of the intensity of pain. Numerical pain rating scores is 0-10. 0 means no pain while 10 means worse pain.
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 17 Jan 2023.
- Individual participant dataSharing planned: No
Related trials for Total Knee Replacement
Not yet recruiting
Opioid Reduction and Enhanced Recovery in Orthopaedic Surgery (OREOS)-Knee
Knee Arthroplasty, Total, Partial Knee Arthroplasty
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Not yet recruiting
Effects of Different Bispectral Index Target Depths on Early Postoperative Recovery Quality in Elderly Patients Undergoing Total Knee Arthroplasty
Total Knee Arthroplasty, Postoperative Recovery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Not yet recruiting
Comparison of Telerehabilitation and Usual Rehabilitation After Knee or Hip Surgery
Orthopedic Surgery, Rehabilitation
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.
Aruba Saeed, PhD* study chair
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Otago Exercise in people with Total Knee Replacement, run by Riphah International University at 1 site in Pakistan.
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 2 inclusion and 3 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 17 Jan 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 Pakistan. 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?
The Functional Reach test (time frame: 24 weeks). The study lists 6 primary outcomes in all. 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 17 Jan 2023.