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

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.

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

Study Overview

• Status: Unknown
• Conditions: Hypertension; Metabolic Syndrome; Overweight and Obesity; Cardiovascular Risk Factor; Sarcopenic Obesity; Disability Physical; Abdominal Obesity
• Intervention / Treatment: Behavioral: Diet; Behavioral: Walking; Behavioral: Nordic Walking

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 Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea P Rossi, Md PhD; Phone Number: 0458122537; Email: andrea.rossi@hotmail.it

Study Locations

• Italy
  • Verona, Italy, 37126
    • Recruiting
    • AOUI Verona
    • Contact: Andrea P Rossi, MD, PhD; Phone Number: 00390458122537; Email: andrea.rossi@hotmail.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda Ospedaliera Universitaria Integrata Verona
• Collaborators: Universita di Verona
• Investigators: Study Director: Mauro Zamboni, AOUI Verona

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2016
• Primary Completion (Anticipated): January 20, 2018
• Study Completion (Anticipated): July 20, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 6, 2017
• First Posted (Actual): July 11, 2017

Study Record Updates

• Last Update Posted (Actual): July 11, 2017
• Last Update Submitted That Met QC Criteria: July 6, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Overnutrition; Nutrition Disorders; Body Weight; Insulin Resistance; Hyperinsulinism; Obesity; Metabolic Syndrome; Overweight; Obesity, Abdominal
• Other Study ID Numbers: 739CESC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No