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

Overview

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.

Interventions

• Other 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
• Other 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
• Other 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.

Primary outcome measures

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

Secondary outcome measures (6)

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Other

Study locations

Italy · 1 center

• IRCCS Fondazione Don Carlo Gnocchi — Milan

Publications

• Mohammad NS, Nazli R, Zafar H, Fatima S. Effects of lipid based Multiple Micronutrients Supplement on the birth outcome of underweight pre-eclamptic women: A randomized clinical trial. Pak J Med Sci. 2022 Jan-Feb;38(1):219-226. doi: 10.12669/pjms.38.1.4396. PMID 35035429
• Conroy DE, Maher JP, Elavsky S, Hyde AL, Doerksen SE. Sedentary behavior as a daily process regulated by habits and intentions. Health Psychol. 2013 Nov;32(11):1149-57. doi: 10.1037/a0031629. Epub 2013 Mar 11. PMID 23477579
• Despres JP, Carpentier AC, Tchernof A, Neeland IJ, Poirier P. Management of Obesity in Cardiovascular Practice: JACC Focus Seminar. J Am Coll Cardiol. 2021 Aug 3;78(5):513-531. doi: 10.1016/j.jacc.2021.05.035. PMID 34325840
• Elavsky S, McAuley E. Physical activity and mental health outcomes during menopause: a randomized controlled trial. Ann Behav Med. 2007 Apr;33(2):132-42. doi: 10.1007/BF02879894. PMID 17447865
• Gholami M, Larijani B, Zahedi Z, Mahmoudian F, Bahrami S, Omran SP, Saadatian Z, Hasani-Ranjbar S, Taslimi R, Bastami M, Amoli MM. Inflammation related miRNAs as an important player between obesity and cancers. J Diabetes Metab Disord. 2019 Nov 26;18(2):675-692. doi: 10.1007/s40200-019-00459-2. eCollection 2019 Dec. PMID 31890692
• Henning RJ. Obesity and obesity-induced inflammatory disease contribute to atherosclerosis: a review of the pathophysiology and treatment of obesity. Am J Cardiovasc Dis. 2021 Aug 15;11(4):504-529. eCollection 2021. PMID 34548951
• La Sala L, Pontiroli AE. Prevention of Diabetes and Cardiovascular Disease in Obesity. Int J Mol Sci. 2020 Oct 31;21(21):8178. doi: 10.3390/ijms21218178. PMID 33142938
• Ipp E, Genter P, Childress K. Semaglutide and Cardiovascular Outcomes in Patients with Type 2 Diabetes. N Engl J Med. 2017 Mar 2;376(9):890-1. doi: 10.1056/NEJMc1615712. No abstract available. PMID 28252263

Identifiers

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

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗