Rehabilitation with Nordic Walking for overweight and obese patients
EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Diabetic patiEnts With Cardiovascular Disease. The VENERE Study
This study tests if Nordic Walking can help overweight and obese patients with diabetes and heart issues get fitter and feel better while also receiving standard rehabilitation support.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione Don Carlo Gnocchi Onlus Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Milan) |
| Trial ID | NCT05987410 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Nordic Walking (NW) as a rehabilitation method for overweight and obese patients with diabetes and recent cardiovascular events. NW combines walking with the use of special sticks, increasing caloric expenditure and engaging a majority of the body's muscles while minimizing stress on joints. The program aims to improve various fitness components, including coordination, endurance, strength, and mobility, under the guidance of an instructor. Participants will also receive standard rehabilitation and cardiological counseling as part of their treatment.
Who should consider this trial
Good fit: Ideal candidates include overweight or obese adults with a BMI of 27 kg/m2 or higher, who have diabetes and have experienced a recent cardiovascular event.
Not a fit: Patients who are unable to walk independently or have acute joint or spine pathologies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance rehabilitation outcomes and overall health for patients with obesity and cardiovascular issues.
How similar studies have performed: Previous studies have shown positive outcomes with similar rehabilitation approaches, suggesting potential for success in this study.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: \- overweight \[Body Mass Index (BMI) ≥ 27 kg/m2\] or obese (BMI ≥30 kg/m2) adult patients with diabetes mellitus and with a recent cardiovascular event and/or coronary revascularization in the previous three months Exclusion Criteria: * inability to walk independently and constantly; * acute joint or spine pathologies that make movement impossible; * the presence of dementia as approved by consultation of the patient's medical record and/or administration of the Montreal Cognitive Assessment (MOCA) test ≤ 15.5 (Nasreddine et al., 2005); * chemotherapy 6 months before surgery; * advanced renal failure; * acute cardiovascular event \< 3 months (unstable angina, AMI with FE \<40%, arrhythmias, valvular disease, intracerebral/subdural haemorrhage, uncontrolled AI); * home oxygen therapy and Non-Invasive Ventilation (NIV) \[excluding Continuous Positive Airway Pressure (CPAP)\].
Where this trial is running
Milan
- IRCCS Fondazione Don Carlo Gnocchi — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Anna Torri, MD — IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
- Study coordinator: Nuccia Morici, MD, Ph.D.
- Email: nmorici@dongnocchi.it
- Phone: 3206359064
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.