Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID05987410

Effectiveness of Rehabilitation Treatment With Nordic Walking in Overweight or Obese Diabetic Patients With Cardiovascular Disease The VENERE Study

Led by Fondazione Don Carlo Gnocchi Onlus · Updated on 2025-02-04

105

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the effectiveness, safety, and adherence to a rehabilitation program using Nordic Walking compared with standard rehabilitation and cardiological counseling in overweight or obese adults with Type II diabetes and cardiovascular complications. Nordic Walking combines special poles with walking to engage about 90% of the body's muscles and improve cardiovascular performance while reducing joint load. The study is a randomized controlled trial with three parallel groups, focusing on cardiovascular performance and exercise adherence over 6 and 12 months after a 3-month intervention. Participants will be assigned to one of three groups: Nordic Walking, Standard Rehabilitation, or Control Group. The Nordic Walking group will attend supervised sessions three times weekly for 12 weeks, each lasting 90 minutes with warm-up, walking, and cool-down phases, progressively increasing intensity. The Standard Rehabilitation group will engage in supervised aerobic exercises five days a week for 40 minutes per session, also gradually increasing intensity. The Control Group receives cardiological counseling with guidance for unsupervised aerobic activity at home. All groups receive a balanced diet plan with moderate caloric restriction based on body composition. During the study, participants will undergo assessments including a Six Minute Walking Test to measure cardiovascular fitness, adherence tracking, evaluations of anxiety, depression, quality of life (SF-12), body mass index changes, and peak oxygen uptake. These measures will be taken at intervals up to 12 months. The study monitors safety and dropout rates, aiming to understand the benefits and feasibility of Nordic Walking compared to other rehabilitation methods in this population.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged 18 years or older
  • Overweight with Body Mass Index (BMI) 27 27 kg/m2 or obese with BMI 30 kg/m2
  • Diagnosed with diabetes mellitus
  • Recent cardiovascular event and/or coronary revascularization within the previous three months
  • Ability to walk independently and constantly
Not Eligible

You will not qualify if you...

  • Inability to walk independently and constantly
  • Acute joint or spine conditions that prevent movement
  • Presence of dementia with Montreal Cognitive Assessment (MOCA) score  15.5
  • Chemotherapy within 6 months before surgery
  • Advanced kidney failure
  • Acute cardiovascular events within the last 3 months (unstable angina, heart attack with ejection fraction less than 40%, arrhythmias, valvular disease, brain hemorrhage, uncontrolled arterial hypertension)
  • Use of home oxygen therapy or non-invasive ventilation (excluding CPAP)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants engage in one of three rehabilitation programs: Nordic Walking sessions three times a week for 12 weeks supervised by a Nordic Walking instructor and a cardiologist; Standard Rehabilitation sessions five days a week for 12 weeks supervised by physiotherapists; or receive cardiological counselling with indications for unsupervised aerobic physical activity. All groups receive guidance on a balanced diet with moderate daily caloric restriction based on initial body composition measurements.

3 to 5 visits per week depending on the assigned rehabilitation program

Follow-up

Duration - Up to 12 months

Participants are monitored for outcomes including walking distance, adherence, anxiety, depression, health survey scores, BMI changes, and peak oxygen uptake for up to 12 months following treatment.

Visits scheduled as needed for outcome assessments

Trial Site Locations

Total: 1 location

1

IRCCS Fondazione Don Carlo Gnocchi

Milan, Italy, 20148

Actively Recruiting

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Research Team

N

Nuccia Morici, MD, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

3

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