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NCT Number: NCT05987410

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

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.

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Key information

Conditions

Cardiovascular Diseases Body Weight Diabete Type 2 Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Overweight and Obesity Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

Location status: Recruiting

Location contact

Anna Torri, MD

CONTACT

[email protected]

3477408748 ext. 0039

Anna Torri, MD

PRINCIPAL_INVESTIGATOR

Eleonora Volpato, Psy.D, Ph.D.

CONTACT

[email protected]

3293782692 ext. 0039

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)].

Treatment and study plan

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.

Primary outcomes

  1. 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)

Secondary outcomes

  1. Adherence

    Time frame: Through intervention completion, an average of 3 months

    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.

  2. Anxiety

    Time frame: An average of 6 months

    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).

  3. Depression

    Time frame: An average of 6 months

    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).

  4. The Short Form Health Survey 12 (SF-12)

    Time frame: An average of 12 months

    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).

  5. Variation in Body Mass Index (BMI)

    Time frame: An average of 12 months

    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.

  6. Peak Oxygen Uptake (VO2)

    Time frame: An average of 6 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Nuccia Morici, MD, Ph.D.

CONTACT

[email protected]

3206359064 ext. 0039

Sponsors and collaborators

Lead sponsor

Fondazione Don Carlo Gnocchi ETS

Other

Registry information

Official study title

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

Acronym: VENERE

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2023
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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