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

NCT05987410 | Recruiting DMC

• 1 other identifier: 27/2023/CE_FdG/FC/SA
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Adherence

  Through intervention completion, an average of 3 months

• Anxiety

  An average of 6 months

• Depression

  An average of 6 months

• The Short Form Health Survey 12 (SF-12)

  An average of 12 months

• Variation in Body Mass Index (BMI)

  An average of 12 months

Study Arms (3)

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.

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.

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.

Other: Cardiological Counselling (CC)

Interventions

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.

Nordic Walking (NW)

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.

Standard Rehabilitation (SR)

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.

Control Group (CG)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

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

Sponsors & Collaborators

• Fondazione Don Carlo Gnocchi Onlus: lead

Study Sites (1)

IRCCS Fondazione Don Carlo Gnocchi

Milan, 20148, Italy

RECRUITING

Related Publications (15)

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  PMID: 38846444 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Diabetes Mellitus, Type 2; Overweight; Obesity

Interventions

Nordic Walking

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Walking; Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Anna Torri, MD

  IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nuccia Morici, MD, Ph.D.

CONTACT

3206359064; nmorici@dongnocchi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Ph.D.

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)