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NCT Number: NCT05026385

The POMELO (Prevention Of MusclE Loss in Osteoarthritis) 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.

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Key information

Conditions

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

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alberta

Edmonton, Alberta, T6G 2P5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Behavioral

Targeted nutrition advice, progressive resistance training exercise, and self-management support

Primary outcomes

  1. Per-protocol adherence (feasibility)

    Time frame: at interim (3 months)

    per-protocol adherence to the intervention >= 60%

  2. Adverse events

    Time frame: at interim (3 months)

    rates of adverse events in the intervention and control arms

  3. Study completion rates (feasibility)

    Time frame: at study completion (10 months)

    study completion rates >= 80%

  4. Acceptability of Intervention Measure (AIM) score

    Time frame: at interim (3 months) and study completion (10 months)

    AIM scores compared between the intervention and control groups

  5. Qualitative data on participants perceptions of acceptability

    Time frame: at interim (3 months) and study completion (10 months)

    qualitative data from open-ended survey and interview questions under each domain of the Theoretical Framework of Acceptability

Secondary outcomes

  1. muscle mass

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    appendicular lean mass assessed by DXA

  2. physical function (chair stands)

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    number of chair stands in 30 seconds

  3. physical function (6MWT distance)

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    6MWT distance

Other outcomes

  1. muscle quality

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in ultrasound-measured thigh muscle volume and echogenicity

  2. fat mass

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in fat mass assessed by DXA

  3. patient-reported health-related quality of life

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in quality of life assessed by EQ-5D

  4. patient-reported arthritis-related pain and function

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in arthritis-related pain and function assessed by WOMAC

  5. self-efficacy for managing chronic disease

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in self-efficacy scores assessed by PROMIS

  6. lipid panel

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed lipid panel (i.e. total cholesterol, LDL, HDL and triglycerides)

  7. c-reactive protein

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed c-reactive protein

  8. insulin

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed insulin

  9. albumin

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed albumin

  10. liver enzymes

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed liver enzymes (ALT and GGT)

  11. glucose

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed glucose

  12. thyroid stimulating hormone

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in blood assessed thyroid stimulating hormone

  13. resting energy expenditure

    Time frame: change from baseline to interim (3 months) and study completion (10 months)

    change in resting energy expenditure using indirect calorimetry

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • The Arthritis Society, Canada

Registry information

Official study title

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

Acronym: POMELO

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 30, 2021
Registry last updated
Jan 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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