WAVE Study- Walking and Aging in VErona Study

Study Overview
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Brief Summary
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Monocentric unblinded two parallel-group randomized controlled trial to evaluate the effect of diet with or without Nordic Walking on weight loss, physical performance and cardiovascular risk factors in overweight and obese population

Detailed Description
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To examine the impact of a 48-week of diet +/- Nordic Walking program on physical performance, muscle function, cardiovascular risk factors and arterial stiffness in community-dwelling overweight and obese elderly men and women.

Official Title
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Effect of Diet and Physical Exercise, With or Without Nordic Walking, on Weight Loss, Physical Performance and Cardiovascular Risk Factors in Elderly Overweight and Obese Subjects.

Conditions
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Abdominal Obesity, Metabolic Syndrome, Disability Physical, Sarcopenic Obesity, Hypertension, Overweight and Obesity, Cardiovascular Risk Factor

Intervention / Treatment
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* Behavioral: Diet
* Behavioral: Walking
* Behavioral: Nordic Walking


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 60-90 years Males and females . BMI > 27 kg/m2 living in Verona (Italy) stable weight in the 3 months not involved in physical exercise programs informed consent sign Exclusion Criteria: cardiovascular disease (unstable angina, recent myocardial infarction, cardiac arrhythmias, heart failure, valvular heart disease, aortic aneurysm, recent intracerebral or subdural hemorrhage, not controlled hypertension) musculoskeletal disease (symptomatic discal hernia, symptomatic arthrosis, acute articular, tendon or ligament lesions, hip prothesis).

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Monocentric unblinded two parallel-group randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diet+Walking<br>52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking | Behavioral: Diet<br>* 52 weeks of Diet supervised by a dietician<br>Behavioral: Walking<br>* 26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking<br>|
| Experimental: Diet+Nordic Walking<br>52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking | Behavioral: Diet<br>* 52 weeks of Diet supervised by a dietician<br>Behavioral: Nordic Walking<br>* 26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max | maximal oxygen consumption | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max changes | maximal oxygen consumption | 3, 6, 9 and 12 months | 
| PWV | pulse wave velocity | 3, 6, 9 and 12 months | 
| muscle strength |  | 3, 6, 9 and 12 months | 
| fat mass |  | 3, 6, 9 and 12 months | 
| muscle mass |  | 3, 6, 9 and 12 months | 
| SF 36 | quality of life | 6 and 12 months | 
| GDS | geriatric depression scale | 6 and 12 months |