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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04733053




Registration number
NCT04733053
Ethics application status
Date submitted
13/01/2021
Date registered
1/02/2021

Titles & IDs
Public title
Effects of a Physiotherapist-delivered Dietary Weight Loss Program in People with Knee OA Who Have Overweight/obesity
Scientific 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
Secondary ID [1] 0 0
U1111-1261-5151
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 0 0
Overweight and Obesity 0 0
Condition category
Condition code
Musculoskeletal 0 0 0 0
Osteoarthritis
Diet and Nutrition 0 0 0 0
Obesity
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Diet plus exercise
Other interventions - Exercise

Experimental: Diet plus exercise - 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.

Active comparator: Exercise - 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.


Other interventions: Diet plus exercise
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.

Other interventions: Exercise
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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Body weight
Timepoint [1] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [1] 0 0
Body mass index (BMI)
Timepoint [1] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [2] 0 0
Waist circumference
Timepoint [2] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [3] 0 0
Waist to hip ratio
Timepoint [3] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [4] 0 0
Severity of knee pain during walking
Timepoint [4] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [5] 0 0
Intermittent and constant osteoarthritis pain measure (iCOAP)
Timepoint [5] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [6] 0 0
Physical function subscale of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timepoint [6] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [7] 0 0
Global overall improvement in knee problems
Timepoint [7] 0 0
6 months post randomization
Secondary outcome [8] 0 0
Quality of life (AQoL-6D)
Timepoint [8] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [9] 0 0
Physical Activity scale for the elderly (PASE)
Timepoint [9] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [10] 0 0
30 sec chair stand test
Timepoint [10] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [11] 0 0
40 m fast paced walk test
Timepoint [11] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [12] 0 0
Stair climb test
Timepoint [12] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [13] 0 0
Quadriceps muscle strength
Timepoint [13] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [14] 0 0
Weight Self-Stigma Questionnaire (WSSQ)
Timepoint [14] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [15] 0 0
Self-efficacy for eating control
Timepoint [15] 0 0
Change between baseline and 6 months post randomization
Secondary outcome [16] 0 0
Arthritis self-efficacy scale
Timepoint [16] 0 0
Change between baseline and 6 months post randomization

Eligibility
Key inclusion criteria
* 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
Minimum age
45 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* 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)
* 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2023
Sample size
Target
Accrual to date
Final
88
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
University of Melbourne - Melbourne
Recruitment postcode(s) [1] 0 0
3010 - Melbourne

Funding & Sponsors
Primary sponsor type
Other
Name
University of Melbourne
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Kim Bennell, PhD
Address 0 0
University of Melbourne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
IPD can be shared

Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Analytic code
When will data be available (start and end dates)?
We will share all data that support results of the trial following publication. Additional data that have not been published will be withheld until at least six months after publication.
Available to whom?
Data will be made available as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner. Analyses for non-commercial purposes are eligible. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required.
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT04733053