AzTrials
AzTrials

Visceral ObesityNCT03450655

Cardio Training of Older Adults With Central Obesity

A study testing 10-week aerobic exercise program in people with Visceral Obesity, run by Region Västerbotten at 1 site in Sweden.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

Given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community. The present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program. Read more about this study

Who is it for?
Ages 70 to 70 years
Conditions the study is for
Visceral Obesity
What is being tested?
10-week aerobic exercise program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
1 siteSweden
Study dates
9 Feb 2018to 28 Sep 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 70 to 70 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Participated in the Healthy Ageing Initiative (a population-based intervention study in Umeå, Sweden)
  • Visceral adipose tissue mass >1 kg (women) or >2 kg (men)

Who cannot join

  • Physical disability that affects ability to perform the exercises
  • Heart failure or severe degenerative condition (e.g. malignant cancer or multiple sclerosis)
  • Myocardial infarction or stroke in the past year
  • Heart condition that can worsen with aerobic exercise (e.g. angina)

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Livsmedicin (LIFE)

    Umeå, Västerbotten County, 907 36

Other trials in Sweden

About this study

Given the increasing prevalence of obesity, there is an urgent need to find better strategies to promote physical activity in the community. The present study will invite 70-year-olds with central (abdominal) obesity to participate in a 10-week aerobic exercise program. Participants will be randomly assigned to one of two equally large groups. The first group will complete the exercise program in instructor-led groups. The second group will complete the program at home with the help of an on-line video.

Read the detailed description

Central obesity means having a lot visceral fat, that is, fat located in the abdominal cavity. Visceral fat is a well-established risk factor for cardiovascular disease and all-cause mortality.

Participants will be recruited from the Healthy Ageing Initiative (HAI), an ongoing population-based study that invites all 70-year-olds in Umeå, Sweden, to a health examination. The exercise program will focus is on station-based aerobic exercises and resistance exercises, predominantly with participants' own body weight as resistance. The program is progressive, starting at a moderate pace so that participants learn to perform the exercises properly. The intensity will be aimed at 60-80% of maximal exhaustion, and each exercise bout will last 60 seconds with 20 seconds of rest between bouts. The program was developed by seniors in the bachelor's program in exercise physiology at Umeå University, Sweden.

Being tested
10-week aerobic exercise program
Medical subject headings
Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 10-week aerobic exercise programOther

    An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.

Study groups in NCT03450655
Study groupRoleWhat they receive
Intervention GroupExperimentalWeeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.
Receives: Other: 10-week aerobic exercise program
Control groupExperimentalWeeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.
Receives: Other: 10-week aerobic exercise program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in visceral adipose tissue mass

    Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).

    Measured: 0, 10, 20, and 31 weeks

Secondary outcomes (13)

  1. Change in body composition

    Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)

    Measured: 0, 10, 20, and 31 weeks

  2. Change in Body Mass Index (kg/m^2)

    Measured: 0, 10, 20, and 31 weeks

  3. Change in blood pressure (mmHg)

    Taken after 15 min of rest

    Measured: 0, 10, 20, and 31 weeks

  4. Change in blood-lipid profile

    Measured: 0, 10, 20, and 31 weeks

  5. Change in fasting blood glucose

    Veinous blood samples taken after > 4 h of fasting

    Measured: 0, 10, 20, and 31 weeks

  6. Change in isometric muscle strength

    Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA). The better of two successive trials will be recorded.

    Measured: 0, 10, 20, and 31 weeks

  7. Change in physical capacity

    Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle

    Measured: 0, 10, 20, and 31 weeks

  8. Change in resting metabolic rate

    As measured by indirect calorimetry

    Measured: 0, 10, 20, and 31 weeks

  9. Change in health-related quality of life

    As measured by RAND-36

    Measured: 0, 10, 20, and 31 weeks

  10. Change in self-reported physical activity

    Assessed using IPAQ-SF

    Measured: 0, 10, 20, and 31 weeks

  11. Change in Microbiota composition

    Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition

    Measured: 0, 10, 20, and 31 weeks

  12. Change in dietary habits

    85 item food frequency questionnaire

    Measured: 0, 10, 20, and 31 weeks

  13. Change in concentration of inflammatory markers

    Measured: 0, 10, 20, and 31 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2018
  2. Study start9 Feb 2018
  3. Primary completion28 Sep 2018 (estimated)
  4. Study completion28 Sep 2018 (estimated)

Resources

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
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03450655
Sponsor's protocol ID
VCC-LIFE-4
Status last verified
Feb 2018
First submitted
16 Feb 2018
Last updated
1 Mar 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ballin M, Hult A, Bjork S, Lundberg E, Nordstrom P, Nordstrom A. Web-based exercise versus supervised exercise for decreasing visceral adipose tissue in older adults with central obesity: a randomized controlled trial. BMC Geriatr. 2020 May 12;20(1):173. doi: 10.1186/s12877-020-01577-w.

    PubMed 32398024

  • Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of interval training on quality of life and cardiometabolic risk markers in older adults: a randomized controlled trial. Clin Interv Aging. 2019 Sep 4;14:1589-1599. doi: 10.2147/CIA.S213133. eCollection 2019.

    PubMed 31564841

  • Ballin M, Lundberg E, Sorlen N, Nordstrom P, Hult A, Nordstrom A. Effects of Interval Training on Visceral Adipose Tissue in Centrally Obese 70-Year-Old Individuals: A Randomized Controlled Trial. J Am Geriatr Soc. 2019 Aug;67(8):1625-1631. doi: 10.1111/jgs.15919. Epub 2019 Apr 23.

    PubMed 31012497

Questions about this trial

What is this clinical trial studying?

A study testing 10-week aerobic exercise program in people with Visceral Obesity, run by Region Västerbotten at 1 site in Sweden.

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 2 inclusion and 4 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 1 Mar 2018. 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 Sweden. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in visceral adipose tissue mass (time frame: 0, 10, 20, and 31 weeks). 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 NCT03450655, which also lists 3 linked publications.

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 1 Mar 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in