Cardio Training of Older Adults With Central Obesity

February 28, 2018 updated by: Anna Nordström, Region Västerbotten
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Västerbotten
      • Umeå, Västerbotten, Sweden, 907 36
        • Livsmedicin (LIFE)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

70 years to 70 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.
Other: 10-week aerobic exercise program
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
Experimental: Control group
Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.
Other: 10-week aerobic exercise program
An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in visceral adipose tissue mass
Time Frame: 0, 10, 20, and 31 weeks
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).
0, 10, 20, and 31 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in body composition
Time Frame: 0, 10, 20, and 31 weeks
Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)
0, 10, 20, and 31 weeks
Change in Body Mass Index (kg/m^2)
Time Frame: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks
Change in blood pressure (mmHg)
Time Frame: 0, 10, 20, and 31 weeks
Taken after 15 min of rest
0, 10, 20, and 31 weeks
Change in blood-lipid profile
Time Frame: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks
Change in fasting blood glucose
Time Frame: 0, 10, 20, and 31 weeks
Veinous blood samples taken after > 4 h of fasting
0, 10, 20, and 31 weeks
Change in isometric muscle strength
Time Frame: 0, 10, 20, and 31 weeks
Measured in non-dominant hand with dynamometer (Jamar, Lafayette Instrument, USA). The better of two successive trials will be recorded.
0, 10, 20, and 31 weeks
Change in physical capacity
Time Frame: 0, 10, 20, and 31 weeks
Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle
0, 10, 20, and 31 weeks
Change in resting metabolic rate
Time Frame: 0, 10, 20, and 31 weeks
As measured by indirect calorimetry
0, 10, 20, and 31 weeks
Change in health-related quality of life
Time Frame: 0, 10, 20, and 31 weeks
As measured by RAND-36
0, 10, 20, and 31 weeks
Change in self-reported physical activity
Time Frame: 0, 10, 20, and 31 weeks
Assessed using IPAQ-SF
0, 10, 20, and 31 weeks
Change in Microbiota composition
Time Frame: 0, 10, 20, and 31 weeks
Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition
0, 10, 20, and 31 weeks
Change in dietary habits
Time Frame: 0, 10, 20, and 31 weeks
85 item food frequency questionnaire
0, 10, 20, and 31 weeks
Change in concentration of inflammatory markers
Time Frame: 0, 10, 20, and 31 weeks
0, 10, 20, and 31 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Region Västerbotten

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Umeå University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anna Nordström, PhD, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 9, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 28, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 1, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • VCC-LIFE-4

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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