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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in South Africa

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

  1. describe habitual physical activity and sedentary behaviour patterns in knee osteoarthritis patients who are scheduled for total knee arthroplasty,
  2. 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
  3. 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).

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.

  1. Habitual physical activity level

    Measured using the ActiGraph accelerometer

    Measured: Baseline

  2. Habitual physical activity level

    Measured using the ActiGraph accelerometer

    Measured: Six weeks post-op

  3. Habitual physical activity level

    Measured using the ActiGraph accelerometer

    Measured: Between three and six months post-op

  4. Time spent in sedentary behaviour

    Measured using the activPAL accelerometer

    Measured: Baseline

  5. Time spent in sedentary behaviour

    Measured using the activPAL accelerometer

    Measured: Six weeks post-op

  6. Time spent in sedentary behaviour

    Measured using the activPAL accelerometer

    Measured: Between three and six months post-op

Secondary outcomes (8)
  1. 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

  2. Activity

    Measured using the UCLA activity index (self-report)

    Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op

  3. Pain

    Measured using a visual analogue scale

    Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op

  4. Sleep quality

    Measured using a sleep questionnaire

    Measured: Baseline, 6 weeks post-op, between 3 and 6 months post-op

  5. 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

  6. 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

  7. 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

  8. 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.

  1. First posted5 Feb 2016 (estimated)
  2. Study startAug 2015
  3. Primary completion30 Apr 2017
  4. Study completion30 Apr 2017

Resources

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)
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

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.

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