WAVE Study- Walking and Aging in VErona Study

NCT ID: NCT03212391

Last Updated: 2017-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-19

Study Completion Date

2018-07-20

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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Monocentric unblinded two parallel-group randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Diet+Walking

52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

52 weeks of Diet supervised by a dietician

Walking

Intervention Type BEHAVIORAL

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

Diet+Nordic Walking

52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking

Group Type EXPERIMENTAL

Diet

Intervention Type BEHAVIORAL

52 weeks of Diet supervised by a dietician

Nordic Walking

Intervention Type BEHAVIORAL

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

Interventions

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Diet

52 weeks of Diet supervised by a dietician

Intervention Type BEHAVIORAL

Walking

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

Intervention Type BEHAVIORAL

Nordic Walking

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

Intervention Type BEHAVIORAL

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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Universita di Verona

OTHER

Sponsor Role collaborator

Azienda Ospedaliera Universitaria Integrata Verona

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mauro Zamboni

Role: STUDY_DIRECTOR

AOUI Verona

Locations

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AOUI Verona

Verona, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Andrea P Rossi, Md PhD

Role: CONTACT

0458122537

Facility Contacts

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Andrea P Rossi, MD, PhD

Role: primary

00390458122537

References

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Muollo V, Rossi AP, Milanese C, Zamboni M, Rosa R, Schena F, Pellegrini B. Prolonged unsupervised Nordic walking and walking exercise following six months of supervision in adults with overweight and obesity: A randomised clinical trial. Nutr Metab Cardiovasc Dis. 2021 Apr 9;31(4):1247-1256. doi: 10.1016/j.numecd.2020.12.012. Epub 2020 Dec 17.

Reference Type DERIVED
PMID: 33549445 (View on PubMed)

Other Identifiers

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739CESC

Identifier Type: -

Identifier Source: org_study_id

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