The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial

NCT05026385 | Completed

• 1 other identifier: Pro00107201
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Osteoarthritis, Knee; Obesity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• muscle mass

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

• physical function (chair stands)

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

• physical function (6MWT distance)

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

Other Outcomes (13)

• muscle quality

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

• fat mass

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

• patient-reported health-related quality of life

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

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

NO INTERVENTION

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.

Interventions

Intervention BEHAVIORAL

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

Intervention

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• The Arthritis Society, Canada: collaborator

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2P5, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Interventions

Methods

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carla Prado, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

• Mary Forhan, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

• Kristine Godziuk, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2021
• First Posted: August 30, 2021
• Study Start: September 20, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: January 29, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)