WAVE Study- Walking and Aging in VErona Study

Hypertension Clinical Trial

— WAVE  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03212391
• Other study ID #: 739CESC
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2017
• Last updated: July 6, 2017
• Start date: September 19, 2016
• Est. completion date: July 20, 2018

Study information

• Verified date: July 2017
• Source: Azienda Ospedaliera Universitaria Integrata Verona
• Contact: Andrea P Rossi, Md PhD
• Phone: 0458122537
• Email: andrea.rossi[@]hotmail.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: July 20, 2018
• Est. primary completion date: January 20, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	AOUI Verona	Verona

Sponsors (2)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria Integrata Verona	Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VO2 max	maximal oxygen consumption	12 months
Secondary	VO2 max changes	maximal oxygen consumption	3, 6, 9 and 12 months
Secondary	PWV	pulse wave velocity	3, 6, 9 and 12 months
Secondary	muscle strength		3, 6, 9 and 12 months
Secondary	fat mass		3, 6, 9 and 12 months
Secondary	muscle mass		3, 6, 9 and 12 months
Secondary	SF 36	quality of life	6 and 12 months
Secondary	GDS	geriatric depression scale	6 and 12 months