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

Cardiovascular Diseases Clinical Trial

— VENERE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05987410
• Other study ID #: 27/2023/CE_FdG/FC/SA
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Fondazione Don Carlo Gnocchi Onlus
• Contact: Nuccia Morici, MD, Ph.D.
• Phone: 3206359064
• Email: nmorici[@]dongnocchi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 105
• Est. completion date: December 31, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)].

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabete Type 2
• Diabetes Mellitus, Type 2
• Overweight
• Overweight and Obesity

Intervention

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 KCal) daily caloric restriction concerning the usual caloric expenditure, estimated based on initial body composition measurements.
• 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 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.
• 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.

Locations

Country	Name	City	State
Italy	IRCCS Fondazione Don Carlo Gnocchi	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Don Carlo Gnocchi Onlus

Country where clinical trial is conducted

Italy, 

References & Publications (14)

Baek S, Ha Y, Park HW. Accuracy of Wearable Devices for Measuring Heart Rate During Conventional and Nordic Walking. PM R. 2021 Apr;13(4):379-386. doi: 10.1002/pmrj.12424. Epub 2020 Jul 17. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Graffigna G, Barello S, Bonanomi A, Lozza E, Hibbard J. Measuring patient activation in Italy: Translation, adaptation and validation of the Italian version of the patient activation measure 13 (PAM13-I). BMC Med Inform Decis Mak. 2015 Dec 23;15:109. doi: 10.1186/s12911-015-0232-9. — View Citation

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. — View Citation

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. — View Citation

Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x. — View Citation

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. — View Citation

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. — View Citation

Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x. Erratum In: J Am Geriatr Soc. 2019 Sep;67(9):1991. — View Citation

Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092. — View Citation

Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Six Minute Walking Test (6MWT) distance in meters	Assess distance in meters, determined by the Six Minute Walking Test (6MWT) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)	An average of 6 months
Secondary	Adherence	Monitoring of adherence to the intervention considering the number of sessions of the treatment [Nordic Walking (NW); Standard Rehabilitation (SR) or Control Group (CG) intervention] attended during the 3 months.	Through intervention completion, an average of 3 months
Secondary	Anxiety	To verify the effectiveness of the interventions in reducing the levels of anxiety as detected by The Generalized Anxiety Disorder Scale (GAD-7) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). The following cut-offs correlate with level of anxiety severity: Score 0-4: Minimal Anxiety; Score 5-9: Mild Anxiety; Score 10-14: Moderate Anxiety; Score greater than 15: Severe Anxiety (Spitzer et al., 2006).	An average of 6 months
Secondary	Depression	To verify the effectiveness of the interventions in reducing the levels of depression as detected by The Patient Health Questionnaire-9 (PHQ-9) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2). Regarding severity, PHQ-9 comprises five categories, where a cut-off point of 0-4 indicates no depressive symptoms, 5-9 mild depressive symptoms, 10-14 moderate depressive symptoms, 15-19 moderately-severe depressive symptoms, and 20-27 severe depressive symptoms (Kroenke and Spitzer, 2002).	An average of 6 months
Secondary	The Short Form Health Survey 12 (SF-12)	To verify the effectiveness of the interventions in improving the levels of Quality of Life detected thanks to The Short Form Health Survey 12 (SF-12) (Ware et al., 2000) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).	An average of 12 months
Secondary	Variation in Body Mass Index (BMI)	To verify the effectiveness of the interventions in improving the Body Mass Index (BMI) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups at baseline (T0), the end of the rehabilitation treatment (T1), after 3 months of observation (T2), 12 months (T3).; An improvement of at least 10% in BMI is considered significant.	An average of 12 months
Secondary	Peak Oxygen Uptake (VO2)	Assess increasing in Peak Oxygen Uptake (VO2) in the Nordic Walking (NW) group compared to the Standard Rehabilitation (SR) and Control (CG) Groups group at baseline (T0), the end of the rehabilitation treatment (T1), and after 3 months of observation (T2)	An average of 6 months