Abdominal ObesityWAVENCT03212391
WAVE Study- Walking and Aging in VErona Study
A study testing Diet, Walking and Nordic Walking in people with Abdominal Obesity and Metabolic Syndrome, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Abdominal Obesity, Metabolic Syndrome, Disability Physical
- What is being tested?
- Diet, Walking and Nordic Walking
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteItaly
- Study dates
- 19 Sep 2016to 20 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
AOUI Verona
Verona, 37126
Andrea P Rossi, MD, PhD, 00390458122537, andrea.rossi@hotmail.it
About this study
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.
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
Read the 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.
- Conditions
- Abdominal Obesity, Metabolic Syndrome, Disability Physical, Sarcopenic Obesity, Hypertension, Overweight and Obesity
- Being tested
- Diet, Walking, Nordic Walking
- Medical subject headings
- Obesity, Abdominal, Metabolic Syndrome, Hypertension, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietBehavioural
52 weeks of Diet supervised by a dietician
WalkingBehavioural
26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
Nordic WalkingBehavioural
26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
| Study group | Role | What they receive |
|---|---|---|
| Diet+Walking | Experimental | 52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking Receives: Behavioral: Diet; Behavioral: Walking |
| Diet+Nordic Walking | Experimental | 52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking Receives: Behavioral: Diet; Behavioral: Nordic Walking |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2 max
maximal oxygen consumption
Measured: 12 months
Secondary outcomes (7)
VO2 max changes
maximal oxygen consumption
Measured: 3, 6, 9 and 12 months
PWV
pulse wave velocity
Measured: 3, 6, 9 and 12 months
muscle strength
Measured: 3, 6, 9 and 12 months
fat mass
Measured: 3, 6, 9 and 12 months
muscle mass
Measured: 3, 6, 9 and 12 months
SF 36
quality of life
Measured: 6 and 12 months
GDS
geriatric depression scale
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start19 Sep 2016
- Primary completion20 Jan 2018 (estimated)
- Study completion20 Jul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Abdominal ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Monocentric unblinded two parallel-group randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Collaborators
- Universita di Verona
- Responsible party
- Sponsor
- Investigators
- Mauro Zamboni, Study director, AOUI Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03212391
- Sponsor's protocol ID
- 739CESC
- Acronym
- WAVE
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 11 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33549445
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03212391
- Acronym / sponsor ID
- WAVE / 739CESC
- Conditions
- Abdominal Obesity, Metabolic Syndrome, Disability Physical, Sarcopenic Obesity, Hypertension, Overweight and Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Collaborators
- Universita di Verona
- Study start
- 19 Sep 2016 (actual)
- Primary completion
- 20 Jan 2018 (estimated)
- Study completion
- 20 Jul 2018 (estimated)
- First posted
- 11 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Monocentric unblinded two parallel-group randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Diet+Walking | Experimental | Behavioral: Diet, Behavioral: Walking52 weeks of Diet+26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking |
| Diet+Nordic Walking | Experimental | Behavioral: Diet, Behavioral: Nordic Walking52 weeks of Diet+26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 60-90 years
- . BMI > 27 kg/m2
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diet52 weeks of Diet supervised by a dietician | Behavioural | Diet+Nordic Walking, Diet+Walking |
| Walking26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking | Behavioural | Diet+Walking |
| Nordic Walking26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking | Behavioural | Diet+Nordic Walking |
Primary outcome
VO2 max
Time frame: 12 months
maximal oxygen consumption
7 secondary outcomes
VO2 max changes
Time frame: 3, 6, 9 and 12 months
PWV
Time frame: 3, 6, 9 and 12 months
muscle strength
Time frame: 3, 6, 9 and 12 months
fat mass
Time frame: 3, 6, 9 and 12 months
muscle mass
Time frame: 3, 6, 9 and 12 months
SF 36
Time frame: 6 and 12 months
GDS
Time frame: 6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2017.
- Derived from this study: PubMed 33549445Muollo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mauro Zamboni study director
AOUI Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet, Walking and Nordic Walking in people with Abdominal Obesity and Metabolic Syndrome, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrea P Rossi, Md PhD (0458122537, andrea.rossi@hotmail.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VO2 max (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03212391, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2017.