Osteoarthritis, KneePOMELONCT05026385
The POMELO (Prevention Of MusclE Loss in Osteoarthritis) Trial
A study testing Intervention in people with Osteoarthritis, Knee and Obesity, run by University of Alberta at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Osteoarthritis, Knee, Obesity
- What is being tested?
- Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- 20 Sep 2021to 21 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed 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.
- Conditions
- Osteoarthritis, Knee, Obesity
- Being tested
- Intervention
- Medical subject headings
- Osteoarthritis, Knee, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionBehavioural
Targeted nutrition advice, progressive resistance training exercise, and self-management support
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-protocol adherence (feasibility)
per-protocol adherence to the intervention >= 60%
Measured: at interim (3 months)
Adverse events
rates of adverse events in the intervention and control arms
Measured: at interim (3 months)
Study completion rates (feasibility)
study completion rates >= 80%
Measured: at study completion (10 months)
Acceptability of Intervention Measure (AIM) score
AIM scores compared between the intervention and control groups
Measured: 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
Measured: at interim (3 months) and study completion (10 months)
Secondary outcomes (3)
muscle mass
appendicular lean mass assessed by DXA
Measured: change from baseline to interim (3 months) and study completion (10 months)
physical function (chair stands)
number of chair stands in 30 seconds
Measured: change from baseline to interim (3 months) and study completion (10 months)
physical function (6MWT distance)
6MWT distance
Measured: change from baseline to interim (3 months) and study completion (10 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start20 Sep 2021
- Primary completion21 Jul 2023
- Study completion21 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Responsible party
- Sponsor
- Investigators
- Carla Prado, PhD, Principal investigator, University of AlbertaMary Forhan, PhD, Principal investigator, University of TorontoKristine Godziuk, PhD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026385
- Sponsor's protocol ID
- Pro00107201
- Acronym
- POMELO
- Status last verified
- Jan 2024
- First submitted
- 4 Aug 2021
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05026385
- Acronym / sponsor ID
- POMELO / Pro00107201
- Conditions
- Osteoarthritis, Knee, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- The Arthritis Society, Canada
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 21 Jul 2023 (actual)
- Study completion
- 21 Jul 2023 (actual)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: InterventionThe 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. |
| 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. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionTargeted nutrition advice, progressive resistance training exercise, and self-management support | Behavioural | Intervention |
Primary outcome
Per-protocol adherence (feasibility)
Time frame: at interim (3 months)
per-protocol adherence to the intervention >= 60%
Adverse events
Time frame: at interim (3 months)
rates of adverse events in the intervention and control arms
Study completion rates (feasibility)
Time frame: at study completion (10 months)
study completion rates >= 80%
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
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
3 secondary outcomes
muscle mass
Time frame: change from baseline to interim (3 months) and study completion (10 months)
physical function (chair stands)
Time frame: change from baseline to interim (3 months) and study completion (10 months)
physical function (6MWT distance)
Time frame: change from baseline to interim (3 months) and study completion (10 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
Related trials for Osteoarthritis, Knee
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The Feasibility of a Virtual/Home-based OA Treatment Program in Older Adults With OA and Multimorbidity
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Exploring Factors Linked to Worsening Over Time in People With Early-stage Knee Osteoarthritis and Those With Prior Proven Acute Knee Injury.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carla Prado, PhD principal investigator
University of Alberta
Mary Forhan, PhD principal investigator
University of Toronto
Kristine Godziuk, PhD principal investigator
University of Alberta
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Osteoarthritis, Knee and Obesity, run by University of Alberta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Per-protocol adherence (feasibility) (time frame: at interim (3 months)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2024.