Effects of a Physiotherapist-delivered Dietary Weight Loss Program in People with Knee OA Who Have Overweight/obesity

NCT04733053 | Completed DMC

• 1 other identifier: U1111-1261-5151
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Knee Osteoarthritis; Overweight and Obesity

Outcome Measures

Primary Outcomes (1)

• 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

  Change between baseline and 6 months post randomization

Secondary Outcomes (16)

• Body mass index (BMI)

  Change between baseline and 6 months post randomization

• Waist circumference

  Change between baseline and 6 months post randomization

• Waist to hip ratio

  Change between baseline and 6 months post randomization

• Severity of knee pain during walking

  Change between baseline and 6 months post randomization

• Intermittent and constant osteoarthritis pain measure (iCOAP)

  Change between baseline and 6 months post randomization

Other Outcomes (15)

• Adverse events

  6 months post randomization

• Attendance at consultations

  Throughout intervention period (0-6 months)

• Duration of consultations

  Throughout intervention period (0-6 months)

Study Arms (2)

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.

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.

Other: Exercise

Interventions

Diet plus exercise OTHER

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.

Diet plus exercise

Exercise OTHER

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.

Diet plus exercise; Exercise

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Melbourne: lead

Study Sites (1)

University of Melbourne

Melbourne, Victoria, 3010, Australia

Location

Related Publications (2)

• 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.

  PMID: 38637135 DERIVED

• Bennell 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.

  PMID: 35907828 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Overweight; Obesity

Interventions

Diet; Exercise

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Kim Bennell, PhD

  University of Melbourne

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The components of each treatment arm will be disclosed to participants as we wish to test the interventions under real world conditions whereby consumers are fully informed about the nature of the components before choosing whether or not they wish to participate. The research staff collecting non-self-reported outcome measures (including the primary outcome) will be blinded to group allocation. The staff member collecting laboratory measures at 6 months will be different to the staff member who collects the baseline data. It is not possible to blind physiotherapists as they are providing interventions to both trial arms (in order to ensure physiotherapist-related factors such as personality, clinical practice experience etc are similar across groups and cannot confound results). The person performing the statistical analyses will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: February 1, 2021
• Study Start: October 29, 2021
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: December 9, 2024

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

AU (1)