The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial (POMELO)

Targeted Knee Osteoarthritis Care for Adults With a BMI ≥35 kg/m2: the Prevention Of MusclE Loss in Osteoarthritis (P.O.M.E.L.O.) Feasibility and Pilot Randomized Trial

Treatment options for individuals who have advanced knee osteoarthritis (OA) and a body mass index (BMI) ≥35 kg/m2 are limited, and this patient population may be neglected in current clinical care pathways for OA management. These individuals are considered to be at high risk for complications with total knee arthroplasty (TKA), and as a result may not be eligible for this procedure unless they lose significant weight. However, there is limited evidence for endorsing weight loss as beneficial prior to TKA. Further, unsupervised weight loss could put patients at risk for muscle loss and development of sarcopenic obesity, a health condition that negatively impacts mobility and mortality. This suggests that weight loss might not be the primary treatment goal for this patient population. Integrated non-surgical treatment approaches are needed that can target the specific needs of this knee OA patient group. This study will examine the feasibility and acceptability of a personalized, multicomponent intervention, and its effects on body composition and physical function compared to usual care.

Study Overview

• Status: Completed
• Conditions: Obesity; Osteoarthritis, Knee
• Intervention / Treatment: Behavioral: Intervention

Detailed Description

The primary objectives of the POMELO study are to determine if a multicomponent behavioural intervention that includes personalized nutrition recommendations, progressive resistance training exercise, and chronic disease self-management support is feasible and acceptable for individuals living with advanced knee OA and a BMI ≥35 kg/m2. The secondary objectives are to assess potential effects of the intervention on muscle mass and physical function compared to usual care. The intervention is delivered over three months, followed by six months of ongoing maintenance support. Assessments are completed at baseline, interim (after the 3 month intervention phase), and at study end (after the 6 month maintenance phase) [for a total study period of 10 months]. This project will inform and influence the future development and implementation of more personalized knee OA treatment approaches for adults with a BMI ≥35 kg/m2 and reduce health disparities in access to effective care. Findings will also contribute to improved health outcomes for this vulnerable patient population, and enhanced delivery of health services by offering an alternative treatment pathway targeted to patient needs.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2P5
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• body mass index (BMI) ≥35 kg/m2
• unilateral or bilateral knee osteoarthritis (KL grade ≥2 and clinical symptoms)
• able to provide written, informed consent in English
• able to attend assessment appointments in Edmonton, Alberta
• have reliable and unlimited access to internet and a laptop, computer or tablet at home for access to videoconferencing sessions
• have space at home to complete exercises with equipment provided, or able to attend in-person exercise sessions

Exclusion Criteria:

• any medical conditions where participation in resistance exercise or nutrition adjustments are contraindicated
• neurological disorders (i.e. multiple sclerosis)
• post-traumatic OA with a fracture that impacts joint (secondary to injury or accident)
• rheumatoid arthritis
• prior bariatric surgery
• prior knee or hip replacement surgery
• recently (within 3 months) taken anabolic steroids or other muscle building compounds

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The intervention group will receive initial nutrition and exercise consultations with a Registered Dietitian (RD) and Clinical Exercise Physiologist (CEP) to personalize the study protocol and recommendations to their needs. The intervention period (3 months) includes: a) whole-body resistance training exercise sessions completed three-times per week (at-home with loaned equipment and/or in-person at the research gym); b) biweekly nutrition education provided through video conferencing; and c) biweekly OA self-management support provided through video conferencing. After the 3 month intervention, participants will receive bimonthly phone calls from a study staff member to encourage continued behavior changes during the 6 month maintenance phase.	Behavioral: Intervention; Targeted nutrition advice, progressive resistance training exercise, and self-management support
No Intervention: Usual Care; The control group will follow standard care procedures, which includes their usual activities. The control group will receive bimonthly contact during the study period through phone calls with a study staff member to encourage retention. However no recommendations or advice on nutrition, exercise or self-management will be provided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Per-protocol adherence (feasibility)	per-protocol adherence to the intervention >= 60%	at interim (3 months)
Adverse events	rates of adverse events in the intervention and control arms	at interim (3 months)
Study completion rates (feasibility)	study completion rates >= 80%	at study completion (10 months)
Acceptability of Intervention Measure (AIM) score	AIM scores compared between the intervention and control groups	at interim (3 months) and study completion (10 months)
Qualitative data on participants perceptions of acceptability	qualitative data from open-ended survey and interview questions under each domain of the Theoretical Framework of Acceptability	at interim (3 months) and study completion (10 months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle mass	appendicular lean mass assessed by DXA	change from baseline to interim (3 months) and study completion (10 months)
physical function (chair stands)	number of chair stands in 30 seconds	change from baseline to interim (3 months) and study completion (10 months)
physical function (6MWT distance)	6MWT distance	change from baseline to interim (3 months) and study completion (10 months)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
muscle quality	change in ultrasound-measured thigh muscle volume and echogenicity	change from baseline to interim (3 months) and study completion (10 months)
fat mass	change in fat mass assessed by DXA	change from baseline to interim (3 months) and study completion (10 months)
patient-reported health-related quality of life	change in quality of life assessed by EQ-5D	change from baseline to interim (3 months) and study completion (10 months)
patient-reported arthritis-related pain and function	change in arthritis-related pain and function assessed by WOMAC	change from baseline to interim (3 months) and study completion (10 months)
self-efficacy for managing chronic disease	change in self-efficacy scores assessed by PROMIS	change from baseline to interim (3 months) and study completion (10 months)
lipid panel	change in blood assessed lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides)	change from baseline to interim (3 months) and study completion (10 months)
c-reactive protein	change in blood assessed c-reactive protein	change from baseline to interim (3 months) and study completion (10 months)
insulin	change in blood assessed insulin	change from baseline to interim (3 months) and study completion (10 months)
albumin	change in blood assessed albumin	change from baseline to interim (3 months) and study completion (10 months)
liver enzymes	change in blood assessed liver enzymes (ALT and GGT)	change from baseline to interim (3 months) and study completion (10 months)
glucose	change in blood assessed glucose	change from baseline to interim (3 months) and study completion (10 months)
thyroid stimulating hormone	change in blood assessed thyroid stimulating hormone	change from baseline to interim (3 months) and study completion (10 months)
resting energy expenditure	change in resting energy expenditure using indirect calorimetry	change from baseline to interim (3 months) and study completion (10 months)

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: The Arthritis Society, Canada
• Investigators: Principal Investigator: Carla Prado, PhD, University of Alberta; Principal Investigator: Mary Forhan, PhD, University of Toronto; Principal Investigator: Kristine Godziuk, PhD, University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2021
• Primary Completion (Actual): July 21, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: August 4, 2021
• First Submitted That Met QC Criteria: August 23, 2021
• First Posted (Actual): August 30, 2021

Study Record Updates

• Last Update Posted (Estimated): January 29, 2024
• Last Update Submitted That Met QC Criteria: January 26, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: Pro00107201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No