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Intervention for Osteoarthritis(POMELO Trial)

Waitlist Available
Led By Carla Prado, PhD
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
unilateral or bilateral knee osteoarthritis (KL grade ≥2 and clinical symptoms)
body mass index (BMI) ≥35 kg/m2
Must not have
Be younger than 18 years old
Screening 3 weeks
Treatment Varies
Follow Upat interim (3 months) and study completion (10 months)
Awards & highlights
No Placebo-Only Group

POMELO Trial Summary

This trial will study the feasibility and acceptability of a personalized, multicomponent intervention for people with advanced knee osteoarthritis and a BMI ≥35 kg/m2. The goal is to see if this intervention can improve body composition and physical function compared to usual care.

Eligible Conditions
  • Osteoarthritis
  • Obesity

POMELO Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
You have a body mass index (BMI) of 35 or higher.

POMELO Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at interim (3 months) and study completion (10 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at interim (3 months) and study completion (10 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acceptability of Intervention Measure (AIM) score
Adverse events
Per-protocol adherence (feasibility)
+2 more
Secondary outcome measures
muscle mass
physical function (6MWT distance)
physical function (chair stands)
Other outcome measures
c-reactive protein
fat mass
+10 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

POMELO Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: InterventionExperimental Treatment1 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.
Group II: Usual CareActive Control1 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.
First Studied
Drug Approval Stage
How many patients have taken this drug
Completed Phase 4

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
870 Previous Clinical Trials
391,655 Total Patients Enrolled
9 Trials studying Osteoarthritis
740 Patients Enrolled for Osteoarthritis
The Arthritis Society, CanadaOTHER
20 Previous Clinical Trials
4,567 Total Patients Enrolled
4 Trials studying Osteoarthritis
418 Patients Enrolled for Osteoarthritis
Carla Prado, PhDPrincipal InvestigatorUniversity of Alberta
8 Previous Clinical Trials
571 Total Patients Enrolled

Media Library

Personalized Multicomponent Intervention (NA) Clinical Trial Eligibility Overview. Trial Name: NCT05026385 — N/A
Osteoarthritis Research Study Groups: Usual Care, Intervention
Osteoarthritis Clinical Trial 2023: Personalized Multicomponent Intervention Highlights & Side Effects. Trial Name: NCT05026385 — N/A
Personalized Multicomponent Intervention (NA) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05026385 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the eligibility criteria for this clinical trial encompass individuals aged 25 and over?

"This clinical trial is recruiting individuals aged between 40 and 75."

Answered by AI

Is registration for this experiment currently open?

"Clinicaltrials.gov shows that this clinical experiment is seeking participants at present time; it was first made available on September 20th 2021 and its last modification happened on April 5th 2022."

Answered by AI

Is there a way for me to become involved in this medical experiment?

"This medical experiment is searching for 50 participants aged 40 to 75 who suffer from obesity. Successful candidates must have clinical evidence of unilateral or bilateral knee osteoarthritism obesity. Successful candidates must have clinical evidence of unilateral or bilateral knee osteoarthritis (KL grade ≥2 and symptoms), reliable internet access with a laptop, computer or tablet at home, BMI >35 kg/m2, the ability to attend check-ups in Edmonton Alberta, sufficient space at home to practice exercise routines with supplied equipment, and either the aptitude (or location) necessary for attending in person physical activity sessions."

Answered by AI

How many individuals have been enrolled in this exploration?

"Affirmative, the information located on clinicaltrials.gov indicates that this research endeavour is actively accepting candidates. Initially posted on September 20th 2021, it was last updated on April 5th of 2022 and requires 50 participants for its single site."

Answered by AI
~16 spots leftby Nov 2024