EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients

Официальное название

EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Diabetic patiEnts With Cardiovascular Disease. The VENERE Study

Обзор

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.

Вмешательства

• Другое Nordic Walking (NW)
  The experimental group will carry out NW sessions three times a week for 12 weeks, supervised by a NW instructor and under the control of a cardiologist. The duration of each NW session will initially be 90 minutes: 10 minutes of warm-up, 60 of NW, and 15 minutes of cool-down. The intensity of the course will be gradually increased each week, starting at 70 to 85% of the heart rate (HR) reserve. It will also receive indications relating to a balanced diet plan which proposes a moderate (300-400
• Другое Standard Rehabilitation (SR)
  The second group will follow a standard rehabilitation program with an initial cardiological prescription and supervised by physiotherapists, carried out 5 days a week with sessions lasting 40 minutes, including 5 minutes of warm-up up), 30 min of aerobic physical activity on a conveyor belt or cycle ergometer and 5 minutes of cooling down (cool down). The intensity of your aerobic activity will gradually increase each week, starting at 70 to 85% of HR reserve. It will also receive indications r
• Другое Cardiological Counselling (CC)
  The third group of participants will receive cardiological counselling with indications of unsupervised aerobic physical activity. The group will also receive indications relating to a balanced diet plan which proposes a moderate (300-400 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.

Первичные конечные точки

• Six Minute Walking Test (6MWT) distance in meters [Срок оценки: An average of 6 months]

Вторичные конечные точки (6)

• Adherence [Срок оценки: Through intervention completion, an average of 3 months]
• Anxiety [Срок оценки: An average of 6 months]
• Depression [Срок оценки: An average of 6 months]
• The Short Form Health Survey 12 (SF-12) [Срок оценки: An average of 12 months]
• Variation in Body Mass Index (BMI) [Срок оценки: An average of 12 months]
• Peak Oxygen Uptake (VO2) [Срок оценки: An average of 6 months]

Критерии участия

Критерии включения

\- 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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Италия · 1 центр

• IRCCS Fondazione Don Carlo Gnocchi — Milan

Публикации

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Идентификаторы

NCT: NCT05987410 · 27/2023/CE_FdG/FC/SA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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