Back to resultsEffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients (VENERE)
Primary Purpose
Cardiovascular Diseases, Diabete Type 2, Overweight and Obesity
Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Nordic Walking (NW)
Standard Rehabilitation (SR)
Cardiological Counselling (CC)
Sponsored by
About this trial
This is an interventional other trial for Cardiovascular Diseases focused on measuring Nordic Walking (NW), cardiovascular disease, diabetes Type II, overweight, obesity, Six Minute Walking Test (6MWT), adherence, rehabilitation
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)].
Sites / Locations
- IRCCS Fondazione Don Carlo Gnocchi
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Nordic Walking (NW)
Standard Rehabilitation (SR)
Control Group (CG)
Arm Description
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.
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.
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.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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).
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).
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).
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.
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)
Full Information
NCT ID
NCT05987410
First Posted
August 3, 2023
Last Updated
August 3, 2023
Sponsor
Fondazione Don Carlo Gnocchi Onlus
1. Study Identification
Unique Protocol Identification Number
NCT05987410
Brief Title
EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients
Acronym
VENERE
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fondazione Don Carlo Gnocchi Onlus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
105 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nordic Walking (NW)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard Rehabilitation (SR)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Group (CG)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Nordic Walking (NW)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Rehabilitation (SR)
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Cardiological Counselling (CC)
Intervention Description
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 Measure Information:
Title
Six Minute Walking Test (6MWT) distance in meters
Description
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)
Time Frame
An average of 6 months
Secondary Outcome Measure Information:
Title
Adherence
Description
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.
Time Frame
Through intervention completion, an average of 3 months
Title
Anxiety
Description
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).
Time Frame
An average of 6 months
Title
Depression
Description
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).
Time Frame
An average of 6 months
Title
The Short Form Health Survey 12 (SF-12)
Description
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).
Time Frame
An average of 12 months
Title
Variation in Body Mass Index (BMI)
Description
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.
Time Frame
An average of 12 months
Title
Peak Oxygen Uptake (VO2)
Description
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)
Time Frame
An average of 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)].
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nuccia Morici, MD, Ph.D.
Phone
3206359064
Ext
0039
Email
nmorici@dongnocchi.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Torri, MD
Organizational Affiliation
IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
IRCCS Fondazione Don Carlo Gnocchi
City
Milan
ZIP/Postal Code
20148
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Torri, MD
Phone
3477408748
Ext
0039
Email
atorri@dongnocchi.it
First Name & Middle Initial & Last Name & Degree
Eleonora Volpato, Psy.D, Ph.D.
Phone
3293782692
Ext
0039
Email
evolpato@dongnocchi.it
First Name & Middle Initial & Last Name & Degree
Anna Torri, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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EffectiVenEss of a Rehabilitation Treatment With Nordic Walking in obEse or oveRweight Patients
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