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Intervention for Osteoarthritis(POMELO Trial)

N/A

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

Timeline

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

Select...

You have a body mass index (BMI) of 35 or higher.

POMELO Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at interim (3 months) and study completion (10 months)

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

albumin

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intervention

2011

Completed Phase 4

~73800

0 / 2Eligibility criteria met

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 osteoarthritis m 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

Recent research and studies

clinicaltrials.govStudy

The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial

Carla Prado 2021. "The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05026385.

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