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

Unknown

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Anticipated)

80

Phase

  • 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

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
Intervention / Treatment
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

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

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

Region Västerbotten

Collaborators

Umeå University

Investigators

  • 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)

February 9, 2018

Primary Completion (Anticipated)

September 28, 2018

Study Completion (Anticipated)

September 28, 2018

Study Registration Dates

First Submitted

February 16, 2018

First Submitted That Met QC Criteria

February 28, 2018

First Posted (Actual)

March 1, 2018

Study Record Updates

Last Update Posted (Actual)

March 1, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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