The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial

Obesity Clinical Trial

— POMELO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05026385
• Other study ID #: Pro00107201
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: July 21, 2023

Study information

• Verified date: January 2024
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 21, 2023
• Est. primary completion date: July 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Behavioral:
• Intervention
Targeted nutrition advice, progressive resistance training exercise, and self-management support

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	The Arthritis Society, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	muscle quality	change in ultrasound-measured thigh muscle volume and echogenicity	change from baseline to interim (3 months) and study completion (10 months)
Other	fat mass	change in fat mass assessed by DXA	change from baseline to interim (3 months) and study completion (10 months)
Other	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)
Other	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)
Other	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)
Other	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)
Other	c-reactive protein	change in blood assessed c-reactive protein	change from baseline to interim (3 months) and study completion (10 months)
Other	insulin	change in blood assessed insulin	change from baseline to interim (3 months) and study completion (10 months)
Other	albumin	change in blood assessed albumin	change from baseline to interim (3 months) and study completion (10 months)
Other	liver enzymes	change in blood assessed liver enzymes (ALT and GGT)	change from baseline to interim (3 months) and study completion (10 months)
Other	glucose	change in blood assessed glucose	change from baseline to interim (3 months) and study completion (10 months)
Other	thyroid stimulating hormone	change in blood assessed thyroid stimulating hormone	change from baseline to interim (3 months) and study completion (10 months)
Other	resting energy expenditure	change in resting energy expenditure using indirect calorimetry	change from baseline to interim (3 months) and study completion (10 months)
Primary	Per-protocol adherence (feasibility)	per-protocol adherence to the intervention >= 60%	at interim (3 months)
Primary	Adverse events	rates of adverse events in the intervention and control arms	at interim (3 months)
Primary	Study completion rates (feasibility)	study completion rates >= 80%	at study completion (10 months)
Primary	Acceptability of Intervention Measure (AIM) score	AIM scores compared between the intervention and control groups	at interim (3 months) and study completion (10 months)
Primary	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	muscle mass	appendicular lean mass assessed by DXA	change from baseline to interim (3 months) and study completion (10 months)
Secondary	physical function (chair stands)	number of chair stands in 30 seconds	change from baseline to interim (3 months) and study completion (10 months)
Secondary	physical function (6MWT distance)	6MWT distance	change from baseline to interim (3 months) and study completion (10 months)