WAVE Study- Walking and Aging in VErona Study

Not Applicable

• Conditions: Sarcopenic Obesity; Cardiovascular Risk Factor; Metabolic Syndrome; Hypertension; Disability Physical; Overweight and Obesity; Abdominal Obesity
• Interventions: Behavioral: Diet; Behavioral: Walking; Behavioral: Nordic Walking

• Registration Number: NCT03212391
• Lead Sponsor: 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

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.

Study Timeline

• Study Start: 2016-09-19
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-06
• Last Update Submitted: 2017-07-06
• Study First Posted: 2017-07-11
• Last Update Posted: 2017-07-11
• Primary Completion: 2018-01-20
• Study Completion: 2018-07-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 64

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
VO2 max	12 months	maximal oxygen consumption

Secondary Outcome Measures

Name	Time	Method
PWV	3, 6, 9 and 12 months	pulse wave velocity
VO2 max changes	3, 6, 9 and 12 months	maximal oxygen consumption
muscle mass	3, 6, 9 and 12 months
SF 36	6 and 12 months	quality of life
muscle strength	3, 6, 9 and 12 months
fat mass	3, 6, 9 and 12 months
GDS	6 and 12 months	geriatric depression scale

Trial Locations

Locations (1)

AOUI Verona; 🇮🇹 Verona, Italy