Back to resultsWAVE Study- Walking and Aging in VErona Study (WAVE)
Primary Purpose
Abdominal Obesity, Metabolic Syndrome, Disability Physical
Status
Unknown status
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Diet
Walking
Nordic Walking
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Obesity
Eligibility 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).
Sites / Locations
- AOUI VeronaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Diet+Walking
Diet+Nordic Walking
Arm Description
52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
Outcomes
Primary Outcome Measures
VO2 max
maximal oxygen consumption
Secondary Outcome Measures
VO2 max changes
maximal oxygen consumption
PWV
pulse wave velocity
muscle strength
fat mass
muscle mass
SF 36
quality of life
GDS
geriatric depression scale
Full Information
NCT ID
NCT03212391
First Posted
July 6, 2017
Last Updated
July 6, 2017
Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
Universita di Verona
1. Study Identification
Unique Protocol Identification Number
NCT03212391
Brief Title
WAVE Study- Walking and Aging in VErona Study
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2016 (Actual)
Primary Completion Date
January 20, 2018 (Anticipated)
Study Completion Date
July 20, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda Ospedaliera Universitaria Integrata Verona
Collaborators
Universita di Verona
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Obesity, Metabolic Syndrome, Disability Physical, Sarcopenic Obesity, Hypertension, Overweight and Obesity, Cardiovascular Risk Factor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Monocentric unblinded two parallel-group randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diet+Walking
Arm Type
Experimental
Arm Description
52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
Arm Title
Diet+Nordic Walking
Arm Type
Experimental
Arm Description
52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
52 weeks of Diet supervised by a dietician
Intervention Type
Behavioral
Intervention Name(s)
Walking
Intervention Description
26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
Intervention Type
Behavioral
Intervention Name(s)
Nordic Walking
Intervention Description
26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
Primary Outcome Measure Information:
Title
VO2 max
Description
maximal oxygen consumption
Time Frame
12 months
Secondary Outcome Measure Information:
Title
VO2 max changes
Description
maximal oxygen consumption
Time Frame
3, 6, 9 and 12 months
Title
PWV
Description
pulse wave velocity
Time Frame
3, 6, 9 and 12 months
Title
muscle strength
Time Frame
3, 6, 9 and 12 months
Title
fat mass
Time Frame
3, 6, 9 and 12 months
Title
muscle mass
Time Frame
3, 6, 9 and 12 months
Title
SF 36
Description
quality of life
Time Frame
6 and 12 months
Title
GDS
Description
geriatric depression scale
Time Frame
6 and 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea P Rossi, Md PhD
Phone
0458122537
Email
andrea.rossi@hotmail.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mauro Zamboni
Organizational Affiliation
AOUI Verona
Official's Role
Study Director
Facility Information:
Facility Name
AOUI Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea P Rossi, MD, PhD
Phone
00390458122537
Email
andrea.rossi@hotmail.it
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
33549445
Citation
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.
Results Reference
derived
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WAVE Study- Walking and Aging in VErona Study
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