Clinical trial NCT05987410: EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients
Official title: EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Diabetic patiEnts With Cardiovascular Disease. The VENERE Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Diabete Type 2
Overweight and Obesity
Keywords: Nordic Walking (NW)
cardiovascular disease
diabetes Type II
overweight
obesity
Six Minute Walking Test (6MWT)
adherence
rehabilitation
Lead sponsor: Fondazione Don Carlo Gnocchi Onlus
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a single-center, randomized controlled intervention study with three parallel arms (NW=Nordic Walking, SR=standard rehabilitation and CG=control group), open label.
Primary purpose: OTHER

Brief summary: Nordic Walking (NW) is a biomechanically correct walking technique that originated in Finland in the 1930s as an off-season training method for cross-country skiers. In the NW, the use of special sticks is combined with "conventional" walking: this involves a greater caloric expenditure, with an energy consumption higher by 20-30% compared to walking without sticks, and also toning of the upper part of the body, in particular triceps, shoulders and back, and the involvement of about 90% of the body's muscles, while maintaining a reduced load on ligaments and joints (Baek \& Ha, 2021). The NW acts simultaneously and effectively on different components of fitness: coordination, endurance, strength, and mobility. It does not require sudden accelerations and is based on a technique that is easy to learn (with the help of an instructor), especially as regards maintaining correct posture. Finally, in addition to the cardiovascular benefits, NW has also been shown to effectively reduce the risk of falls in the elderly. The study is a single-center, randomized controlled trial (RCT), with a three-parallel-arm design, open-label. The primary objective is to evaluate the efficacy (in terms of cardiovascular performance), safety, and adherence (in terms of dropout rate) to the exercise prescription after 6 and 12 months follow-up of a 3-month NW intervention compared with standard rehabilitation training (SR, 3 months) in obese/overweight diabetic patients with cardiovascular (CV) complications. The study will enroll in parallel a control group that can access only generic cardiological counseling with a prescription for unsupervised home exercise.


Eligibility 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) \[excluding Continuous Positive Airway Pressure (CPAP)\].

Primary outcomes:
measure: Six Minute Walking Test (6MWT) distance in meters
timeFrame: An average of 6 months
Secondary outcomes:
measure: Adherence
timeFrame: Through intervention completion, an average of 3 months
measure: Anxiety
timeFrame: An average of 6 months
measure: Depression
timeFrame: An average of 6 months
measure: The Short Form Health Survey 12 (SF-12)
timeFrame: An average of 12 months
measure: Variation in Body Mass Index (BMI)
timeFrame: An average of 12 months
measure: Peak Oxygen Uptake (VO2)
timeFrame: An average of 6 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS Fondazione Don Carlo Gnocchi
Study officials:
affiliation: IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
name: Anna Torri, MD
role: PRINCIPAL_INVESTIGATOR
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