Knee OsteoarthritisNCT02675062
Habitual Physical Activity and Sedentary Behavior Following Total Knee Arthroplasty
An observational study of Knee Osteoarthritis, run by University of Witwatersrand, South Africa at 1 site in South Africa.
Trial summary
The purpose of this study is to determine whether habitual physical activity and sedentary behaviour improve six weeks and between three to six months after total knee replacement surgery in people with osteoarthritis. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- How many people
- 80 participants
- Where
- 1 siteSouth Africa
- Study dates
- Aug 2015to 30 Apr 2017
- Phase
- Observational
- 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 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include all knee osteoarthritis patients receiving care at the Charlotte Maxeke Johannesburg Academic Hospital. Patients will be recruited from the Orthopaedic Division of the hospital. The participants for this study will be knee osteoarthritis patients scheduled (on surgical waiting list) for a single primary total knee arthroplasty. Knee osteoarthritis will be diagnosed based on clinical criteria as defined by the American Rheumatism Association. The grade of knee osteoarthritis will be graded using the Kellgren and Lawrence classification of severity.
Who may be able to join
- clinical diagnosis of knee osteoarthritis
- Kellgren and Lawrence grade 4 severity of knee osteoarthritis
- refractory to analgesics for at least six months
- undergoing primary or first-time single total knee arthroplasty
- are ambulant with or without assistive devices
Who cannot join
- use assistive ambulatory devices for mobility problems other than knee osteoarthritis
- scheduled for bilateral knee arthroplasty, a second knee arthroplasty or revision
- scheduled for total hip replacement
- co-morbidities or medical conditions that affect physical activity such as congestive heart failure, stroke and other neurological problems, chronic obstructive pulmonary disease, gout and/or sepsis
- rheumatoid arthritis
- undergoing another surgery following the knee arthroplasty
- non-ambulant or wheel chair-bound
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Division of Orthopaedics, Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng, 2193
About this study
Official title: The Effect of Total Knee Arthroplasty on Habitual Physical Activity, Sedentary Behaviour and Health Outcomes in Patients With Osteoarthritis
The purpose of this study is to determine whether habitual physical activity and sedentary behaviour improve six weeks and between three to six months after total knee replacement surgery in people with osteoarthritis.
Read the detailed description
The aims of this study are to
- describe habitual physical activity and sedentary behaviour patterns in knee osteoarthritis patients who are scheduled for total knee arthroplasty,
- investigate the effects of unilateral primary total knee arthroplasty on objectively and subjectively measured physical activity, sedentary behaviour and health outcomes of knee OA patients and
- compare subjective measures of functional ability and sedentary behaviour (questionnaires) with objective measures of habitual physical activity and sedentary behaviour (accelerometry) both before and after total knee arthroplasty.
Study design:
This a longitudinal follow-up study of a cohort of participants who have been diagnosed with knee osteoarthritis and who will all be undergoing total knee arthroplasty. After enrolment into the study, baseline assessments will be done prior to total knee arthroplasty. After total knee arthroplasty, participants will be followed-up and the same assessments done at baseline will also be done at 6 weeks, and 3 to 6 months post-operatively. Habitual physical activity and sedentary behaviour will be measured using accelerometry (Actigraph GTX3+ and ActivPal monitors) at the specific time points.The ActiGraph will be worn by participants for 24 hours/day for seven days at each of the assessment time points. It will be attached to an elastic nylon strap which the participants can wear as a belt around the waist on the side of right/left hip (depending on which knee is being operated on). Thus, the ActiGraph will be worn on the side of left hip if the total knee arthroplasty is on the left knee and vice versa. Participants will be asked to remove the ActiGraph when showering, bathing or swimming. After seven days of accelerometer wear, the accelerometers will be collected at the next possible visit to the hospital or arrangement will be made for collection from participants at a location most convenient to them. An ActivPAL will be taped to the thigh of the patient with waterproof taping and the patient will be asked to keep the ActivPAL on for the same amount of time as the ActiGraph. The ActivPAL can be covered with waterproof taping therefore, there will be no need to remove the ActivPAL when showering, bathing or swimming. The ActivPAL will be collected at the same time as the ActiGraph. In addition, general health, functional ability, generic quality of life and sleep and pain questionnaires will be conducted at each time point on each participant.
Study Site:
The study will be conducted at the Charlotte Maxeke Academic Hospital in Johannesburg, South Africa. It is an accredited central hospital with about 1088 beds serving patients from across Gauteng and neighbouring provinces. The hospital is situated in Parktown and also, serves as the main teaching hospital for the University of the Witwatersrand, Faculty of Health Sciences. Study participants will be recruited from the Division of Orthopaedics in the hospital. This hospital is chosen because: (1) it is a tertiary hospital that runs several specialist clinics including the Orthopaedic Division where total knee arthroplasty is performed and (2) there is a collaboration between the Academic staff of the Faculty of Health Sciences of University of the Witwatersrand and the hospital Staff for teaching and research which will facilitate accessibility to patients.
Sample Size Determination:
Based on an anticipated 2% decrease in the amount of time spent in sedentary behaviour per day (which, for an average 16 hour day, equates to a 20 minute reduction), a sample size calculation shows that a total sample of 107 participants will be required in this study to detect a significant effect of knee arthroplasty on sedentary behaviour with a power of 80%.
The effect of the total knee arthroplasty on the change in habitual physical activity and sedentary behaviour will be assessed between the three timepoints (baseline, six weeks and three to six months).
- Conditions
- Knee Osteoarthritis
- Keywords
- Accelerometry, Osteoarthritis, Habitual physical activity, Sedentary behaviour, Knee arthroplasty
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What is being measured
The primary outcome is the main question the study is designed to answer.
Habitual physical activity level
Measured using the ActiGraph accelerometer
Measured: Baseline
Habitual physical activity level
Measured using the ActiGraph accelerometer
Measured: Six weeks post-op
Habitual physical activity level
Measured using the ActiGraph accelerometer
Measured: Between three and six months post-op
Time spent in sedentary behaviour
Measured using the activPAL accelerometer
Measured: Baseline
Time spent in sedentary behaviour
Measured using the activPAL accelerometer
Measured: Six weeks post-op
Time spent in sedentary behaviour
Measured using the activPAL accelerometer
Measured: Between three and six months post-op
Secondary outcomes (8)
Knee osteoarthritis-specific quality of life
Measured using Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Activity
Measured using the UCLA activity index (self-report)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Pain
Measured using a visual analogue scale
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Sleep quality
Measured using a sleep questionnaire
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Total summed score of pain, activity, sport and recreation function and knee-related quality of life.
Measured using the Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Score of pain and physical disability
Measured using the Oxford Knee Score (OKS)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Knee functional score
Measured using the Knee Society Clinical Rating System (KSS)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Patient functional score
Measured using the Knee Society Clinical Rating System (KSS)
Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study startAug 2015
- Primary completion30 Apr 2017
- Study completion30 Apr 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.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Witwatersrand, South Africa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rebecca Meiring, University of Witwatersrand, South Africa
- Investigators
- Rebecca Meiring, PhD, Study director, University of Witwatersrand, South Africa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02675062
- Sponsor's protocol ID
- M150323
- Status last verified
- May 2017
- First submitted
- 29 Jan 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Meiring RM, Frimpong E, Mokete L, Pietrzak J, Van Der Jagt D, Tikly M, McVeigh JA. Rationale, design and protocol of a longitudinal study assessing the effect of total knee arthroplasty on habitual physical activity and sedentary behavior in adults with osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:281. doi: 10.1186/s12891-016-1141-5.
PubMed 27411316
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Total Knee Arthroplasty on Habitual Physical Activity, Sedentary Behaviour and Health Outcomes in Patients With Osteoarthritis
- ClinicalTrials.gov ID
- NCT02675062
- Acronym / sponsor ID
- M150323
- Conditions
- Knee Osteoarthritis
- Keywords
- Accelerometry, Osteoarthritis, Habitual physical activity, Sedentary behaviour, Knee arthroplasty
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Witwatersrand, South AfricaUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 5 Feb 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.
The purpose of this study is to determine whether habitual physical activity and sedentary behaviour improve six weeks and between three to six months after total knee replacement surgery in people with osteoarthritis.
Detailed description
The aims of this study are to
- describe habitual physical activity and sedentary behaviour patterns in knee osteoarthritis patients who are scheduled for total knee arthroplasty,
- investigate the effects of unilateral primary total knee arthroplasty on objectively and subjectively measured physical activity, sedentary behaviour and health outcomes of knee OA patients and
- compare subjective measures of functional ability and sedentary behaviour (questionnaires) with objective measures of habitual physical activity and sedentary behaviour (accelerometry) both before and after total knee arthroplasty.
Study design:
This a longitudinal follow-up study of a cohort of participants who have been diagnosed with knee osteoarthritis and who will all be undergoing total knee arthroplasty. After enrolment into the study, baseline assessments will be done prior to total knee arthroplasty. After total knee arthroplasty, participants will be followed-up and the same assessments done at baseline will also be done at 6 weeks, and 3 to 6 months post-operatively. Habitual physical activity and sedentary behaviour will be measured using accelerometry (Actigraph GTX3+ and ActivPal monitors) at the specific time points.The ActiGraph will be worn by participants for 24 hours/day for seven days at each of the assessment time points. It will be attached to an elastic nylon strap which the participants can wear as a belt around the waist on the side of right/left hip (depending on which knee is being operated on). Thus, the ActiGraph will be worn on the side of left hip if the total knee arthroplasty is on the left knee and vice versa. Participants will be asked to remove the ActiGraph when showering, bathing or swimming. After seven days of accelerometer wear, the accelerometers will be collected at the next possible visit to the hospital or arrangement will be made for collection from participants at a location most convenient to them. An ActivPAL will be taped to the thigh of the patient with waterproof taping and the patient will be asked to keep the ActivPAL on for the same amount of time as the ActiGraph. The ActivPAL can be covered with waterproof taping therefore, there will be no need to remove the ActivPAL when showering, bathing or swimming. The ActivPAL will be collected at the same time as the ActiGraph. In addition, general health, functional ability, generic quality of life and sleep and pain questionnaires will be conducted at each time point on each participant.
Study Site:
The study will be conducted at the Charlotte Maxeke Academic Hospital in Johannesburg, South Africa. It is an accredited central hospital with about 1088 beds serving patients from across Gauteng and neighbouring provinces. The hospital is situated in Parktown and also, serves as the main teaching hospital for the University of the Witwatersrand, Faculty of Health Sciences. Study participants will be recruited from the Division of Orthopaedics in the hospital. This hospital is chosen because: (1) it is a tertiary hospital that runs several specialist clinics including the Orthopaedic Division where total knee arthroplasty is performed and (2) there is a collaboration between the Academic staff of the Faculty of Health Sciences of University of the Witwatersrand and the hospital Staff for teaching and research which will facilitate accessibility to patients.
Sample Size Determination:
Based on an anticipated 2% decrease in the amount of time spent in sedentary behaviour per day (which, for an average 16 hour day, equates to a 20 minute reduction), a sample size calculation shows that a total sample of 107 participants will be required in this study to detect a significant effect of knee arthroplasty on sedentary behaviour with a power of 80%.
The effect of the total knee arthroplasty on the change in habitual physical activity and sedentary behaviour will be assessed between the three timepoints (baseline, six weeks and three to six months).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include all knee osteoarthritis patients receiving care at the Charlotte Maxeke Johannesburg Academic Hospital. Patients will be recruited from the Orthopaedic Division of the hospital. The participants for this study will be knee osteoarthritis patients scheduled (on surgical waiting list) for a single primary total knee arthroplasty. Knee osteoarthritis will be diagnosed based on clinical criteria as defined by the American Rheumatism Association. The grade of knee osteoarthritis will be graded using the Kellgren and Lawrence classification of severity.
Key inclusion criteria (5 listed)
- clinical diagnosis of knee osteoarthritis
- Kellgren and Lawrence grade 4 severity of knee osteoarthritis
- refractory to analgesics for at least six months
- undergoing primary or first-time single total knee arthroplasty
- are ambulant with or without assistive devices
Key exclusion criteria (7 listed)
- use assistive ambulatory devices for mobility problems other than knee osteoarthritis
- scheduled for bilateral knee arthroplasty, a second knee arthroplasty or revision
- scheduled for total hip replacement
- co-morbidities or medical conditions that affect physical activity such as congestive heart failure, stroke and other neurological problems, chronic obstructive pulmonary disease, gout and/or sepsis
- rheumatoid arthritis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Habitual physical activity level
Time frame: Baseline
Measured using the ActiGraph accelerometer
Habitual physical activity level
Time frame: Six weeks post-op
Measured using the ActiGraph accelerometer
Habitual physical activity level
Time frame: Between three and six months post-op
Measured using the ActiGraph accelerometer
Time spent in sedentary behaviour
Time frame: Baseline
Measured using the activPAL accelerometer
Time spent in sedentary behaviour
Time frame: Six weeks post-op
Measured using the activPAL accelerometer
Time spent in sedentary behaviour
Time frame: Between three and six months post-op
Measured using the activPAL accelerometer
8 secondary outcomes
Knee osteoarthritis-specific quality of life
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Activity
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Pain
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Sleep quality
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Total summed score of pain, activity, sport and recreation function and knee-related quality of life.
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Score of pain and physical disability
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Knee functional score
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
Patient functional score
Time frame: Baseline, 6 weeks post-op, between 3 and 6 months post-op
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 3 May 2017.
- Derived from this study: PubMed 27411316Meiring RM, Frimpong E, Mokete L, Pietrzak J, Van Der Jagt D, Tikly M, McVeigh JA. Rationale, design and protocol of a longitudinal study assessing the effect of total knee arthroplasty on habitual physical activity and sedentary behavior in adults with osteoarthritis. BMC Musculoskelet Disord. 2016 Jul 13;17:281. doi: 10.1186/s12891-016-1141-5.
- 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.
Rebecca Meiring, PhD study director
University of Witwatersrand, South Africa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis, run by University of Witwatersrand, South Africa at 1 site in South Africa.
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 5 inclusion and 7 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 3 May 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 South Africa. 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?
Habitual physical activity level (time frame: Baseline). 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?
On the ClinicalTrials.gov record for NCT02675062, 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 3 May 2017.