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WAVE Study- Walking and Aging in VErona Study (WAVE)

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ClinicalTrials.gov Identifier: NCT03212391
Recruitment Status : Recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Sponsor:
Collaborator:
Universita di Verona
Information provided by (Responsible Party):
Azienda Ospedaliera Universitaria Integrata Verona

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Abdominal Obesity Metabolic Syndrome Disability Physical Sarcopenic Obesity Hypertension Overweight and Obesity Cardiovascular Risk Factor Behavioral: Diet Behavioral: Walking Behavioral: Nordic Walking Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Monocentric unblinded two parallel-group randomized controlled trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : September 19, 2016
Estimated Primary Completion Date : January 20, 2018
Estimated Study Completion Date : July 20, 2018

Arm Intervention/treatment
Experimental: Diet+Walking
52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
Behavioral: Diet
52 weeks of Diet supervised by a dietician

Behavioral: Walking
26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking

Experimental: Diet+Nordic Walking
52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
Behavioral: Diet
52 weeks of Diet supervised by a dietician

Behavioral: Nordic Walking
26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking




Primary Outcome Measures :
  1. VO2 max [ Time Frame: 12 months ]
    maximal oxygen consumption


Secondary Outcome Measures :
  1. VO2 max changes [ Time Frame: 3, 6, 9 and 12 months ]
    maximal oxygen consumption

  2. PWV [ Time Frame: 3, 6, 9 and 12 months ]
    pulse wave velocity

  3. muscle strength [ Time Frame: 3, 6, 9 and 12 months ]
  4. fat mass [ Time Frame: 3, 6, 9 and 12 months ]
  5. muscle mass [ Time Frame: 3, 6, 9 and 12 months ]
  6. SF 36 [ Time Frame: 6 and 12 months ]
    quality of life

  7. GDS [ Time Frame: 6 and 12 months ]
    geriatric depression scale



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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03212391


Contacts
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Contact: Andrea P Rossi, Md PhD 0458122537 andrea.rossi@hotmail.it

Locations
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Italy
AOUI Verona Recruiting
Verona, Italy, 37126
Contact: Andrea P Rossi, MD, PhD    00390458122537    andrea.rossi@hotmail.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria Integrata Verona
Universita di Verona
Investigators
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Study Director: Mauro Zamboni AOUI Verona

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Responsible Party: Azienda Ospedaliera Universitaria Integrata Verona
ClinicalTrials.gov Identifier: NCT03212391     History of Changes
Other Study ID Numbers: 739CESC
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Body Weight
Obesity
Overweight
Obesity, Abdominal
Overnutrition
Nutrition Disorders
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases