ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	16 December 2017
Main ID:	NCT03212391
Date of registration:	06/07/2017
Prospective Registration:	No
Primary sponsor:	Azienda Ospedaliera Universitaria Integrata Verona
Public title:	WAVE Study- Walking and Aging in VErona Study WAVE
Scientific 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.
Date of first enrolment:	September 19, 2016
Target sample size:	64
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03212391
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
Phase:	N/A

Countries of recruitment
Italy

Contacts

Name:	Andrea P Rossi, Md PhD
Address:
Telephone:	0458122537
Email:	andrea.rossi@hotmail.it
Affiliation:

Name:	Andrea P Rossi, MD, PhD
Address:
Telephone:	00390458122537
Email:	andrea.rossi@hotmail.it
Affiliation:

Name:	Mauro Zamboni
Address:
Telephone:
Email:
Affiliation:	AOUI Verona

Key inclusion & exclusion criteria

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).

Age minimum: 50 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Disability Physical

Overweight and Obesity

Abdominal Obesity

Hypertension

Sarcopenic Obesity

Cardiovascular Risk Factor

Metabolic Syndrome

Intervention(s)

Behavioral: Diet

Behavioral: Nordic Walking

Behavioral: Walking

Primary Outcome(s)

VO2 max [Time Frame: 12 months]

Secondary Outcome(s)

SF 36 [Time Frame: 6 and 12 months]

muscle mass [Time Frame: 3, 6, 9 and 12 months]

fat mass [Time Frame: 3, 6, 9 and 12 months]

GDS [Time Frame: 6 and 12 months]

muscle strength [Time Frame: 3, 6, 9 and 12 months]

PWV [Time Frame: 3, 6, 9 and 12 months]

VO2 max changes [Time Frame: 3, 6, 9 and 12 months]

Secondary ID(s)

739CESC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Universita di Verona

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.