Cardiovascular DiseasesVENERENCT05987410

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

A study testing Nordic Walking (NW), Standard Rehabilitation (SR) and Cardiological Counselling (CC) in people with Cardiovascular Diseases and Diabete Type 2, run by Fondazione Don Carlo Gnocchi ETS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Cardiovascular Diseases, Diabete Type 2, Overweight and Obesity
What is being tested?: Nordic Walking (NW), Standard Rehabilitation (SR) and Cardiological Counselling (CC)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 105 participants
Where: 1 siteItaly
Study dates: 1 Dec 2023to 31 Dec 2028
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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)].

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nuccia Morici, MD, Ph.D. contact

3206359064 ext. 0039

nmorici@dongnocchi.it

Italy1 site, 1 recruiting

IRCCS Fondazione Don Carlo Gnocchi
Milan, 20148
Anna Torri, MD, 3477408748 ext. 0039, atorri@dongnocchi.it
Eleonora Volpato, Psy.D, Ph.D., 3293782692 ext. 0039, evolpato@dongnocchi.it
Recruiting

Other trials in Italy

About this study

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

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.

Conditions: Cardiovascular Diseases, Diabete Type 2, Overweight and Obesity
Being tested: Nordic Walking (NW), Standard Rehabilitation (SR), Cardiological Counselling (CC)
Keywords: Nordic Walking (NW), cardiovascular disease, diabetes Type II, overweight, obesity, Six Minute Walking Test (6MWT), adherence, rehabilitation
Medical subject headings: Cardiovascular Diseases, Diabetes Mellitus, Type 2, Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Nordic Walking (NW)Other
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)Other
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)Other
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.

Study groups in NCT05987410
Study group	Role	What they receive
Nordic Walking (NW)	Experimental	Nordic walking is a form of physical activity that originated in Finland and has gained popularity worldwide. It involves walking with the use of specially designed poles that resemble ski poles. This activity engages both the upper and lower body, making it a full-body workout. In summary, Nordic walking offers several benefits for cardiovascular individuals with Type II diabetes and those who are obese or overweight. These benefits include improved heart and lung function, better blood glucose control, weight management, low joint impact, muscle strengthening, improved balance and posture, and social engagement. However, it is important to consult with a healthcare provider before starting any new exercise program to ensure it is safe and suitable for individual health conditions and goals. Regular monitoring and adjustments by healthcare professionals can help optimize the benefits and ensure ongoing progress. Receives: Other: Nordic Walking (NW)
Standard Rehabilitation (SR)	Active comparator	A standard rehabilitation program for cardiovascular individuals with Type II diabetes and obesity/overweight typically involves a combination of cardiovascular exercise, strength training, and education on lifestyle modifications. The program is prescribed by a cardiologist and supervised by physiotherapists or exercise specialists. It includes an initial assessment to determine exercise parameters, cardiovascular exercise to improve heart function and manage blood glucose levels, strength training to increase muscle mass and aid in weight management, education on nutrition and lifestyle modifications, and progress tracking and monitoring to optimize outcomes. These programs provide benefits such as improved cardiovascular fitness, better blood glucose control, weight management, enhanced muscle strength, and overall well-being. Receives: Other: Standard Rehabilitation (SR)
Control Group (CG)	Other	Cardiological counseling for cardiovascular individuals with Type II diabetes and obesity/overweight often includes recommendations for unsupervised aerobic physical activity. This type of counseling typically involves a cardiologist providing guidelines and recommendations for safe and effective exercise routines. In summary, it involves an initial assessment to determine exercise capacity and precautions. The cardiologist prescribes specific guidelines for unsupervised aerobic physical activity, including the type, frequency, intensity, and duration of exercise sessions. Safety considerations are provided. The benefits of unsupervised aerobic physical activity include improved cardiovascular health, enhanced blood glucose control, weight management, psychological well-being, and increased energy and stamina. Receives: Other: Cardiological Counselling (CC)

What is being measured

The primary outcome is the main question the study is designed to answer.

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)
Measured: An average of 6 months

Secondary outcomes (6)

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.
Measured: Through intervention completion, an average of 3 months
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).
Measured: An average of 6 months
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).
Measured: An average of 6 months
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).
Measured: An average of 12 months
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.
Measured: An average of 12 months
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)
Measured: An average of 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 202331 Dec 2028

First posted14 Aug 2023
Study start1 Dec 2023
Primary completion30 Sep 2028 (estimated)
Study completion31 Dec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
More trials run by Fondazione Don Carlo Gnocchi ETSThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: None (open label)
Enrolment: 105 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05987410
Sponsor's protocol ID: 27/2023/CE_FdG/FC/SA
Acronym: VENERE
Status last verified: Sep 2026
First submitted: 3 Aug 2023
Last updated: 3 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 28252263
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.
PubMed 32449291
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.
PubMed 26699852
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.
PubMed 11556941
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.
PubMed 15817019
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.
PubMed 16717171
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.
PubMed 8628042
Torri A, Volpato E, Merati G, Milani M, Toccafondi A, Formenti D, La Rosa F, Agostini S, Agliardi C, Oreni L, Sacco A, Rescaldani M, Lucreziotti S, Giglio A, Ferrante G, Barbaro M, Montalto C, Buratti S, Morici N. The VENERE Study: EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in ObEse or OveRweight Diabetic PatiEnts With Cardiovascular Disease. CJC Open. 2024 Jan 16;6(5):735-744. doi: 10.1016/j.cjco.2024.01.002. eCollection 2024 May.
PubMed 38846444

Interested in taking part?

Nuccia Morici, MD, Ph.D.

3206359064 ext. 0039

nmorici@dongnocchi.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 3 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Diabetic patiEnts With Cardiovascular Disease. The VENERE Study
ClinicalTrials.gov ID: NCT05987410
Acronym / sponsor ID: VENERE / 27/2023/CE_FdG/FC/SA
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
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 105 participants (estimated)
Lead sponsor: Fondazione Don Carlo Gnocchi ETSUniversity, hospital or other
Study start: 1 Dec 2023 (actual)
Primary completion: 30 Sep 2028 (estimated)
Study completion: 31 Dec 2028 (estimated)
First posted: 14 Aug 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
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.

Arm	Type	Receives
Nordic Walking (NW)	Experimental	Other: Nordic Walking (NW)Nordic walking is a form of physical activity that originated in Finland and has gained popularity worldwide. It involves walking with the use of specially designed poles that resemble ski poles. This activity engages both the upper and lower body, making it a full-body workout. In summary, Nordic walking offers several benefits for cardiovascular individuals with Type II diabetes and those who are obese or overweight. These benefits include improved heart and lung function, better blood glucose control, weight management, low joint impact, muscle strengthening, improved balance and posture, and social engagement. However, it is important to consult with a healthcare provider before starting any new exercise program to ensure it is safe and suitable for individual health conditions and goals. Regular monitoring and adjustments by healthcare professionals can help optimize the benefits and ensure ongoing progress.
Standard Rehabilitation (SR)	Active comparator	Other: Standard Rehabilitation (SR)A standard rehabilitation program for cardiovascular individuals with Type II diabetes and obesity/overweight typically involves a combination of cardiovascular exercise, strength training, and education on lifestyle modifications. The program is prescribed by a cardiologist and supervised by physiotherapists or exercise specialists. It includes an initial assessment to determine exercise parameters, cardiovascular exercise to improve heart function and manage blood glucose levels, strength training to increase muscle mass and aid in weight management, education on nutrition and lifestyle modifications, and progress tracking and monitoring to optimize outcomes. These programs provide benefits such as improved cardiovascular fitness, better blood glucose control, weight management, enhanced muscle strength, and overall well-being.
Control Group (CG)	Other	Other: Cardiological Counselling (CC)Cardiological counseling for cardiovascular individuals with Type II diabetes and obesity/overweight often includes recommendations for unsupervised aerobic physical activity. This type of counseling typically involves a cardiologist providing guidelines and recommendations for safe and effective exercise routines. In summary, it involves an initial assessment to determine exercise capacity and precautions. The cardiologist prescribes specific guidelines for unsupervised aerobic physical activity, including the type, frequency, intensity, and duration of exercise sessions. Safety considerations are provided. The benefits of unsupervised aerobic physical activity include improved cardiovascular health, enhanced blood glucose control, weight management, psychological well-being, and increased energy and stamina.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (7 listed)

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;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Other	Nordic Walking (NW)
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.	Other	Standard Rehabilitation (SR)
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.	Other	Control Group (CG)

Primary outcome

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

6 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Sep 2026.
Background: PubMed 35035429Mohammad 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.
Background: PubMed 23477579Conroy 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.
Background: PubMed 34325840Despres 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.
Background: PubMed 17447865Elavsky 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.
Background: PubMed 31890692Gholami 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.
Background: PubMed 34548951Henning 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.
Background: PubMed 33142938La 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.
Background: PubMed 28252263Ipp 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.
Background: PubMed 32449291Baek 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.
Background: PubMed 26699852Graffigna 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.
Background: PubMed 11556941Kroenke 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.
Background: PubMed 15817019Nasreddine 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Nuccia Morici, MD, Ph.D. contact

3206359064 ext. 0039

nmorici@dongnocchi.it

Anna Torri, MD principal investigator

IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nuccia Morici, MD, Ph.D. (3206359064 ext. 0039, nmorici@dongnocchi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Six Minute Walking Test (6MWT) distance in meters (time frame: An average of 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05987410, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.