Knee OsteoarthritisNCT04733053
Effects of a Physiotherapist-delivered Dietary Weight Loss Program in People with Knee OA Who Have Overweight/obesity
A study testing Diet plus exercise and Exercise in people with Knee Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
Trial summary
The aim of this randomized controlled trial is to evaluate the effects of a physiotherapist-delivered dietary weight loss program on clinical outcomes among people with knee osteoarthritis (OA) who have overweight or obesity. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Knee Osteoarthritis, Overweight and Obesity
- What is being tested?
- Diet plus exercise and Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteAustralia
- Study dates
- 29 Oct 2021to 1 May 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the National Institute for Health and Care Excellence [47] clinical criteria for OA: age≥45 years; activity-related knee joint pain; morning knee stiffness ≤ 30 mins
- report history of knee pain ≥ 3 months
- report knee pain on most days of the past month
- report a minimum knee pain score of 4 on an 11-point numeric rating scale during walking over the previous week
- body mass index (BMI) >27 kg/m2
- those using hypertensive medication must be willing to have their blood pressure checked (this can be self-monitoring, at a pharmacist or at a GP) if they feel light-headed or dizzy at any point during the study
- able to give informed consent and to participate fully in the interventions and assessment procedures
Who cannot join
- weight >150 kgs (due to the added complexities of additional nutritional requirements for individuals above this weight)
- inability to speak English
- on waiting list for/planning knee/hip surgery or bariatric surgery in next 6 months
- arthroplasty on affected knee
- recent knee surgery on affected knee (past 6 months);
- self-reported inflammatory arthritis (e.g. rheumatoid arthritis)
Show all 10Show fewer
- weight loss of > 2 kg over the previous 3 months
- already actively trying to lose weight by any of the following mechanisms:using meal replacements for weight loss; being a member of a slimming club (e.g. weight watchers); receiving support from another health care professional for weight loss; using any drugs prescribed to aid in weight loss; using structured meal programs for weight loss such as 'Lite n' Easy'
- unwilling to continue current dietary patterns if randomized to exercise only group
- unable to undertake ketogenic VLCD for medical reasons including self-reported: diagnosis of Type 1 diabetes;Type 2 diabetes requiring insulin or other medication apart from metformin; Warfarin use; stroke or cardiac event in previous 6 months; unstable cardiovascular conditions; fluid intake restrictions; renal (kidney) problems (unless clearance is obtained from a general practitioner (GP), including GP confirmation that estimated glomerular filtration rate >30 mL/min/1.73m2); any neurological condition affecting lower limbs; vegan dietary requirements due to complexity of delivering a nutritionally complete diet within the ketogenic diet regime
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The POWER Study: Effects of a Physiotherapist-delivered Dietary Weight Loss Program in Addition to Exercise in People with Knee Osteoarthritis Who Have Overweight or Obesity - a Randomised Controlled Trial
The aim of this randomized controlled trial is to evaluate the effects of a physiotherapist-delivered dietary weight loss program on clinical outcomes among people with knee osteoarthritis (OA) who have overweight or obesity. The primary hypothesis is that a physiotherapist-delivered dietary weight loss plus exercise program will be more effective in achieving weight loss than a physiotherapist-delivered exercise program alone. Approximately 6-9 physiotherapists in Melbourne, Australia will be recruited and trained in weight management for OA patients, as well as trained in how to deliver the specific study interventions. The same therapists will deliver the intervention in both arms of the trial. 88 participants with knee OA will be recruited from the community and randomized into one of the two arms a) diet plus exercise intervention or b) exercise intervention alone. Participants in both groups will be asked to attend 6 consultations with the physiotherapist over 6 months. Questionnaire and laboratory-based outcome measures will be completed by participants at baseline and at the end of the 6 month intervention period. A biostatistician will analyse blinded, de-identified data.
Read the detailed description
Clinical guidelines for the management of knee OA recommend exercise as a core treatment for all patients as well as losing weight for those patients who also have overweight/obesity. However, health care systems are frequently under strain often experiencing limited numbers of, and access to, clinicians with specialist weight loss and health behavior change skills. New models of care for OA are needed that support expanded practice roles for clinicians. Physiotherapists are key providers of exercise therapy for knee OA but the effectiveness of physiotherapists to deliver a dietary weight loss program for patients with knee OA is not known.
This study is a randomized controlled trial for which the aim is to evaluate the effects of a physiotherapist-delivered dietary weight loss program in addition to exercise, on weight loss and other clinical outcomes among people with knee OA who have overweight or obesity. The research question is: Is a 6-month physiotherapist-delivered dietary weight loss plus exercise program more effective for improving clinical outcomes than a physiotherapist-delivered exercise program alone in people with knee OA who have overweight or obesity?
Clinical practice guidelines for knee OA recommend patients who have overweight or obesity should lose at least 5-7.5% of body weight. Therefore the study is powered to detect a conservative between-group difference in weight loss of 5% of body weight assuming no change in weight in the control group (exercise only) based on previous research.
A total of 88 participants with chronic knee pain and a clinical diagnosis of knee OA will be recruited from the community. Participants will be enrolled into the study following informed consent and completion of baseline questionnaires and laboratory-based measures. Each participant will be randomly allocated to receive a: a) diet plus exercise program or; b) exercise program alone, over 6 months.
The randomization schedule will be computer generated and prepared by the biostatistician (permuted block sizes 6 to 12) stratified by physiotherapist and sex of participant. The schedule will be stored on a password-protected website maintained by a researcher not involved in either participant recruitment or administration of outcome measures. Group allocation will be revealed to the physiotherapists and the participants by this same researcher following randomisation.
The physiotherapists will undertake comprehensive training prior to being allocated trial participants. Physiotherapists will be trained in weight management, the ketogenic very low calorie diet and trial procedures.
Study participants in both groups will visit a physiotherapist in-person for six individual sessions over 6 months. Participants will choose the therapist according to location. The same therapist will undertake all consultations with any given participant.
Those in the diet plus exercise group will undertake a ketogenic very low calorie diet (VLCD) which has been demonstrated as a safe and effective means of achieving rapid weight loss in the adult population with overweight/obesity. They will receive meal replacements (maximum 2 per day) for up to 14 weeks from the start of the study as well as educational resources. Both groups will also undertake a home-based lower limb muscle strengthening exercise and physical activity program.
A biostatistician will analyse blinded data. Comparative analyses between groups will use intention-to-treat. Multiple imputation will be used to account for missing data if the proportion of missing data is >5%. For the primary outcome, the difference in mean percentage change in body weight will be compared between groups using mixed linear regression model adjusting for baseline weight and the stratification variables, with random intercepts for treating physiotherapist. Similar analyses will be conducted for continuous secondary outcomes. We will also calculate the proportion of participants achieving ≥5% and ≥10% loss of body weight in both groups. For binary outcomes, logistic regression models will be fit using generalized estimating equations, with risk differences and 95% confidence intervals calculated.
- Conditions
- Knee Osteoarthritis, Overweight and Obesity
- Being tested
- Diet plus exercise, Exercise
- Medical subject headings
- Osteoarthritis, Knee, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet plus exerciseOther
The diet program has two phases: 1) intensive weight loss through a ketogenic very low calorie diet VLCD, and 2) transition from ketogenic VLCD onto a healthy eating plan for weight maintenance. Meal replacements will be provided to participants free of charge from the start of the trial to a maximum of 14 weeks (12 weeks for the ketogenic diet and 2 weeks for transition). If a participant does not wish to transition off the ketogenic diet after 14 weeks but wants to continue or if they wish to recommence the ketogenic diet any time after week 14 they will need to purchase meal replacements themselves at their own cost.
Participants will be encouraged to aim to lose at least 10% body weight.
ExerciseOther
The trial coordinator will have provided participants with educational material about OA, handouts of home exercises including photographs and descriptions, a logbook for recording home program completion and resistance exercise bands ahead of their first appointment. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. Review and modification will occur at each consultation to maintain moderate intensity (effort of ≥5 out of 10 (hard) on a modified Borg Rating of Perceived Exertion scale). The physiotherapist will also prescribe a personalised physical activity plan in collaboration with the participant that is supported and progressed over time.
| Study group | Role | What they receive |
|---|---|---|
| Diet plus exercise | Experimental | The initial physiotherapy consultation for participants in this group will last 75 minutes, with 30 minutes for the exercise component and 45 minutes for the diet component. Thereafter, consultations will last 50 minutes, with 20 minutes for the exercise component and 30 minutes for the diet component. The exercise component will be the same as that described for the exercise alone group. Receives: Other: Diet plus exercise; Other: Exercise |
| Exercise | Active comparator | Physiotherapy consultations for participants in this group will last 30 minutes initially and then 20 minutes thereafter, consistent with clinical practice. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate and a personalised physical activity plan. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight
Measured using calibrated digital laboratory platform scales (TCS-2 series) to 2 decimal places, the percentage of body weight change (baseline-follow up/baseline x100%) will be calculated as the primary outcome
Measured: Change between baseline and 6 months post randomization
Secondary outcomes (16)
Body mass index (BMI)
Calculated from height and weight, in Kg/m2
Measured: Change between baseline and 6 months post randomization
Waist circumference
Measured according to standardised instructions using a tape measure in centimetres to 1 decimal place
Measured: Change between baseline and 6 months post randomization
Waist to hip ratio
Measured according to standardized instructions using a tape measure and presented as a ratio
Measured: Change between baseline and 6 months post randomization
Severity of knee pain during walking
Scored on an 11-point NRS for average knee pain during walking in the last week, Ranges from 0 to 10; where 0=no pain and 10=worst pain possible
Measured: Change between baseline and 6 months post randomization
Intermittent and constant osteoarthritis pain measure (iCOAP)
11-item tool with constant and intermittent pain subscales. Ranges from 0 to 20 for constant pain subscale and 0 to 24 for intermittent subscale and 0 to 44 for total score with 44 being maximal pain
Measured: Change between baseline and 6 months post randomization
Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Scored using 17 questions regarding knee function in the last 48 hours, with Likert response options ranging from no dysfunction to extreme dysfunction. Ranges from 0 (no dysfunction) to 68 (maximum dysfunction)
Measured: Change between baseline and 6 months post randomization
Global overall improvement in knee problems
Scored using a 7-point global rating of change Likert scale from with response options ranging from "much worse" to "much better" when compared to baseline. Participants who indicate that they are "moderately better" or "much better" will be classified as improved. All other respondents will be classified as not improved
Measured: 6 months post randomization
Quality of life (AQoL-6D)
Scored using the 20-item Assessment of Quality of Life II Instrument (6D version), which covers the topics of Independent Living, Relationships, Mental Health, Coping, Pain and Senses to come up with one overall value representing quality of life. Total score ranges from -0.04 to 1.00; higher scores indicate better quality of life
Measured: Change between baseline and 6 months post randomization
Physical Activity scale for the elderly (PASE)
Scored via 10 questions about frequency and duration of recreational, household and occupational physical activity undertaken over the past 7 days. Scores range from 0 to 400+; higher scores indicate greater levels of physical activity
Measured: Change between baseline and 6 months post randomization
30 sec chair stand test
Number of complete chair stands completed in 30 secs. Greater number indicates better function
Measured: Change between baseline and 6 months post randomization
40 m fast paced walk test
Time to taken to walk 4 x 10 m quickly but safely. Measured in Metres/Second. Greater speed indicates better function
Measured: Change between baseline and 6 months post randomization
Stair climb test
Time taken for participant to ascend and descend a flight of stairs. Measured in seconds, shorter time indicates better function
Measured: Change between baseline and 6 months post randomization
Quadriceps muscle strength
Maximum voluntary isometric strength will be assessed using an isokinetic dynamometer with the knee at 60 degrees knee flexion. Peak torque over 3 maximal efforts lasting 3 seconds will be recorded. Measured in Nm/kg
Measured: Change between baseline and 6 months post randomization
Weight Self-Stigma Questionnaire (WSSQ)
Self-reported and scored on a 12-item questionnaire, with two 6-item sub-scales. Each item rated on a 5-point Likert scale where from 1=completely disagree to 5=completely agree. Total and subscale scores will be reported with higher scores indicating greater internalized weight stigma.
Measured: Change between baseline and 6 months post randomization
Self-efficacy for eating control
Weight Efficacy Lifestyle (WEL) Questionnaire Short Form. Scored from 8 statements regarding eating control on a 10-point NRS where 0="Not confident at all that I can resist the desire to eat" and 9="Very confident that I can resist the desire to eat". The WEL Short Form is validated to the original 20 item WEL which was based on 5 constructs [44]: negative emotions, availability, social pressure, physical discomfort, and positive activities. Total scores range from 0-80; higher scores indicate greater eating self-efficacy
Measured: Change between baseline and 6 months post randomization
Arthritis self-efficacy scale
Arthritis self-efficacy scale short form. Scored from 8 questions on a 10-point NRS where 1="Very uncertain" and 10="Very certain". The scale assess self-efficacy for control of pain, physical function and frustration associated with OA. Scores are the mean of the items in each scale. Total scores are an average of the 8 items with a range from 1 to 10; higher scores indicate higher self-efficacy.
Measured: Change between baseline and 6 months post randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2021
- Study start29 Oct 2021
- Primary completion1 May 2023
- Study completion1 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Bennell, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04733053
- Sponsor's protocol ID
- U1111-1261-5151
- Status last verified
- May 2023
- First submitted
- 13 Jan 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD can be shared
Publications
Allison K, Jones S, Hinman RS, Pardo J, Li P, DeSilva A, Quicke JG, Sumithran P, Prendergast J, George E, Holden MA, Foster NE, Bennell KL. Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial. Br J Sports Med. 2024 May 2;58(10):538-547. doi: 10.1136/bjsports-2023-107793.
PubMed 38637135Bennell KL, Jones SE, Hinman RS, McManus F, Lamb KE, Quicke JG, Sumithran P, Prendergast J, George ES, Holden MA, Foster NE, Allison K. Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.
PubMed 35907828
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The POWER Study: Effects of a Physiotherapist-delivered Dietary Weight Loss Program in Addition to Exercise in People with Knee Osteoarthritis Who Have Overweight or Obesity - a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04733053
- Acronym / sponsor ID
- U1111-1261-5151
- Conditions
- Knee Osteoarthritis, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- 29 Oct 2021 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 May 2023 (actual)
- First posted
- 1 Feb 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 aim of this randomized controlled trial is to evaluate the effects of a physiotherapist-delivered dietary weight loss program on clinical outcomes among people with knee osteoarthritis (OA) who have overweight or obesity. The primary hypothesis is that a physiotherapist-delivered dietary weight loss plus exercise program will be more effective in achieving weight loss than a physiotherapist-delivered exercise program alone. Approximately 6-9 physiotherapists in Melbourne, Australia will be recruited and trained in weight management for OA patients, as well as trained in how to deliver the specific study interventions. The same therapists will deliver the intervention in both arms of the trial. 88 participants with knee OA will be recruited from the community and randomized into one of the two arms a) diet plus exercise intervention or b) exercise intervention alone. Participants in both groups will be asked to attend 6 consultations with the physiotherapist over 6 months. Questionnaire and laboratory-based outcome measures will be completed by participants at baseline and at the end of the 6 month intervention period. A biostatistician will analyse blinded, de-identified data.
Detailed description
Clinical guidelines for the management of knee OA recommend exercise as a core treatment for all patients as well as losing weight for those patients who also have overweight/obesity. However, health care systems are frequently under strain often experiencing limited numbers of, and access to, clinicians with specialist weight loss and health behavior change skills. New models of care for OA are needed that support expanded practice roles for clinicians. Physiotherapists are key providers of exercise therapy for knee OA but the effectiveness of physiotherapists to deliver a dietary weight loss program for patients with knee OA is not known.
This study is a randomized controlled trial for which the aim is to evaluate the effects of a physiotherapist-delivered dietary weight loss program in addition to exercise, on weight loss and other clinical outcomes among people with knee OA who have overweight or obesity. The research question is: Is a 6-month physiotherapist-delivered dietary weight loss plus exercise program more effective for improving clinical outcomes than a physiotherapist-delivered exercise program alone in people with knee OA who have overweight or obesity?
Clinical practice guidelines for knee OA recommend patients who have overweight or obesity should lose at least 5-7.5% of body weight. Therefore the study is powered to detect a conservative between-group difference in weight loss of 5% of body weight assuming no change in weight in the control group (exercise only) based on previous research.
A total of 88 participants with chronic knee pain and a clinical diagnosis of knee OA will be recruited from the community. Participants will be enrolled into the study following informed consent and completion of baseline questionnaires and laboratory-based measures. Each participant will be randomly allocated to receive a: a) diet plus exercise program or; b) exercise program alone, over 6 months.
The randomization schedule will be computer generated and prepared by the biostatistician (permuted block sizes 6 to 12) stratified by physiotherapist and sex of participant. The schedule will be stored on a password-protected website maintained by a researcher not involved in either participant recruitment or administration of outcome measures. Group allocation will be revealed to the physiotherapists and the participants by this same researcher following randomisation.
The physiotherapists will undertake comprehensive training prior to being allocated trial participants. Physiotherapists will be trained in weight management, the ketogenic very low calorie diet and trial procedures.
Study participants in both groups will visit a physiotherapist in-person for six individual sessions over 6 months. Participants will choose the therapist according to location. The same therapist will undertake all consultations with any given participant.
Those in the diet plus exercise group will undertake a ketogenic very low calorie diet (VLCD) which has been demonstrated as a safe and effective means of achieving rapid weight loss in the adult population with overweight/obesity. They will receive meal replacements (maximum 2 per day) for up to 14 weeks from the start of the study as well as educational resources. Both groups will also undertake a home-based lower limb muscle strengthening exercise and physical activity program.
A biostatistician will analyse blinded data. Comparative analyses between groups will use intention-to-treat. Multiple imputation will be used to account for missing data if the proportion of missing data is >5%. For the primary outcome, the difference in mean percentage change in body weight will be compared between groups using mixed linear regression model adjusting for baseline weight and the stratification variables, with random intercepts for treating physiotherapist. Similar analyses will be conducted for continuous secondary outcomes. We will also calculate the proportion of participants achieving ≥5% and ≥10% loss of body weight in both groups. For binary outcomes, logistic regression models will be fit using generalized estimating equations, with risk differences and 95% confidence intervals calculated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet plus exercise | Experimental | Other: Diet plus exercise, Other: ExerciseThe initial physiotherapy consultation for participants in this group will last 75 minutes, with 30 minutes for the exercise component and 45 minutes for the diet component. Thereafter, consultations will last 50 minutes, with 20 minutes for the exercise component and 30 minutes for the diet component. The exercise component will be the same as that described for the exercise alone group. |
| Exercise | Active comparator | Other: ExercisePhysiotherapy consultations for participants in this group will last 30 minutes initially and then 20 minutes thereafter, consistent with clinical practice. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate and a personalised physical activity plan. |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Meet the National Institute for Health and Care Excellence [47] clinical criteria for OA: age≥45 years; activity-related knee joint pain; morning knee stiffness ≤ 30 mins
- report history of knee pain ≥ 3 months
- report knee pain on most days of the past month
- report a minimum knee pain score of 4 on an 11-point numeric rating scale during walking over the previous week
- body mass index (BMI) >27 kg/m2
Key exclusion criteria (10 listed)
- weight >150 kgs (due to the added complexities of additional nutritional requirements for individuals above this weight)
- inability to speak English
- on waiting list for/planning knee/hip surgery or bariatric surgery in next 6 months
- arthroplasty on affected knee
- recent knee surgery on affected knee (past 6 months);
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 |
|---|---|---|
| Diet plus exerciseThe diet program has two phases: 1) intensive weight loss through a ketogenic very low calorie diet VLCD, and 2) transition from ketogenic VLCD onto a healthy eating plan for weight maintenance. Meal replacements will be provided to participants free of charge from the start of the trial to a maximum of 14 weeks (12 weeks for the ketogenic diet and 2 weeks for transition). If a participant does not wish to transition off the ketogenic diet after 14 weeks but wants to continue or if they wish to recommence the ketogenic diet any time after week 14 they will need to purchase meal replacements themselves at their own cost. Participants will be encouraged to aim to lose at least 10% body weight. | Other | Diet plus exercise |
| ExerciseThe trial coordinator will have provided participants with educational material about OA, handouts of home exercises including photographs and descriptions, a logbook for recording home program completion and resistance exercise bands ahead of their first appointment. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. Review and modification will occur at each consultation to maintain moderate intensity (effort of ≥5 out of 10 (hard) on a modified Borg Rating of Perceived Exertion scale). The physiotherapist will also prescribe a personalised physical activity plan in collaboration with the participant that is supported and progressed over time. | Other | Diet plus exercise, Exercise |
Primary outcome
Body weight
Time frame: Change between baseline and 6 months post randomization
Measured using calibrated digital laboratory platform scales (TCS-2 series) to 2 decimal places, the percentage of body weight change (baseline-follow up/baseline x100%) will be calculated as the primary outcome
16 secondary outcomes
Body mass index (BMI)
Time frame: Change between baseline and 6 months post randomization
Waist circumference
Time frame: Change between baseline and 6 months post randomization
Waist to hip ratio
Time frame: Change between baseline and 6 months post randomization
Severity of knee pain during walking
Time frame: Change between baseline and 6 months post randomization
Intermittent and constant osteoarthritis pain measure (iCOAP)
Time frame: Change between baseline and 6 months post randomization
Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Time frame: Change between baseline and 6 months post randomization
Global overall improvement in knee problems
Time frame: 6 months post randomization
Quality of life (AQoL-6D)
Time frame: Change between baseline and 6 months post randomization
Physical Activity scale for the elderly (PASE)
Time frame: Change between baseline and 6 months post randomization
30 sec chair stand test
Time frame: Change between baseline and 6 months post randomization
40 m fast paced walk test
Time frame: Change between baseline and 6 months post randomization
Stair climb test
Time frame: Change between baseline and 6 months post randomization
Quadriceps muscle strength
Time frame: Change between baseline and 6 months post randomization
Weight Self-Stigma Questionnaire (WSSQ)
Time frame: Change between baseline and 6 months post randomization
Self-efficacy for eating control
Time frame: Change between baseline and 6 months post randomization
Arthritis self-efficacy scale
Time frame: Change between baseline and 6 months post randomization
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 Dec 2024.
- Derived from this study: PubMed 38637135Allison K, Jones S, Hinman RS, Pardo J, Li P, DeSilva A, Quicke JG, Sumithran P, Prendergast J, George E, Holden MA, Foster NE, Bennell KL. Alternative models to support weight loss in chronic musculoskeletal conditions: effectiveness of a physiotherapist-delivered intensive diet programme for knee osteoarthritis, the POWER randomised controlled trial. Br J Sports Med. 2024 May 2;58(10):538-547. doi: 10.1136/bjsports-2023-107793.
- Derived from this study: PubMed 35907828Bennell KL, Jones SE, Hinman RS, McManus F, Lamb KE, Quicke JG, Sumithran P, Prendergast J, George ES, Holden MA, Foster NE, Allison K. Effectiveness of a telehealth physiotherapist-delivered intensive dietary weight loss program combined with exercise in people with knee osteoarthritis and overweight or obesity: study protocol for the POWER randomized controlled trial. BMC Musculoskelet Disord. 2022 Jul 30;23(1):733. doi: 10.1186/s12891-022-05685-z.
- Individual participant dataSharing planned: Yes. IPD can be shared
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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.
Kim Bennell, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet plus exercise and Exercise in people with Knee Osteoarthritis and Overweight and Obesity, run by University of Melbourne at 1 site in Australia.
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 7 inclusion and 10 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 Dec 2024. 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 Australia. 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?
Body weight (time frame: Change between baseline and 6 months post randomization). 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 NCT04733053, which also lists 2 linked publications.
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 Dec 2024.