WAVE Study- Walking and Aging in VErona Study

NCT03212391 — Not applicable, Unknown, 64 participants, Azienda Ospedaliera Universitaria Integrata Verona

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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.

RegistryNCT03212391, acronym WAVE
StatusUnknown
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment64 (Estimated)
SponsorAzienda Ospedaliera Universitaria Integrata Verona (Other); collaborators: Universita di Verona
ConditionsAbdominal Obesity, Metabolic Syndrome, Disability Physical, Sarcopenic Obesity, Hypertension, Overweight and Obesity, Cardiovascular Risk Factor
InterventionsDiet, Walking, Nordic Walking (Behavioral)
Datesstart 2016-09-19, primary completion 2018-01-20 (estimated), completion 2018-07-20 (estimated), first posted 2017-07-11, last updated 2017-07-11
Locations1 site in Italy

Related Papers Related Patents Related Grants Related Experts
All trials for Abdominal Obesity All trials for Metabolic Syndrome All trials of Diet All trials of Walking

-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

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Diet+WalkingExperimentalBehavioral: Diet; Behavioral: Walking52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
Diet+Nordic WalkingExperimentalBehavioral: Diet; Behavioral: Nordic Walking52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
  • Diet (Behavioral): 52 weeks of Diet supervised by a dietician
  • Walking (Behavioral): 26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
  • Nordic Walking (Behavioral): 26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking

+Outcome measures

Primary outcomes

  • VO2 max [12 months]: maximal oxygen consumption

Secondary outcomes

  • VO2 max changes [3, 6, 9 and 12 months]: maximal oxygen consumption
  • PWV [3, 6, 9 and 12 months]: pulse wave velocity
  • 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 [6 and 12 months]: quality of life
  • GDS [6 and 12 months]: geriatric depression scale

+Eligibility

Sex: All, ages: 50 Years to 90 Years, accepts healthy volunteers

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).

+Locations (1)

FacilityCityCountryStatus
AOUI VeronaVeronaItalyRecruiting

+Publications

  • Results publication: 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. PMID 33549445

+Investigators