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Cardio Training of Older Adults With Central Obesity

Primary Purpose

Visceral Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

10-week aerobic exercise program

About this trial

This is an interventional treatment trial for Visceral Obesity

Eligibility Criteria

70 Years - 70 Years (Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

Livsmedicin (LIFE)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Intervention Group

Control group

Arm Description

Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.

Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.

Outcomes

Primary Outcome Measures

Change in visceral adipose tissue mass

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

Secondary Outcome Measures

Change in body composition

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

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

Change in blood pressure (mmHg)

Taken after 15 min of rest

Change in blood-lipid profile

Change in fasting blood glucose

Veinous blood samples taken after > 4 h of fasting

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.

Change in physical capacity

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

Change in resting metabolic rate

As measured by indirect calorimetry

Change in health-related quality of life

As measured by RAND-36

Change in self-reported physical activity

Assessed using IPAQ-SF

Change in Microbiota composition

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

Change in dietary habits

85 item food frequency questionnaire

Change in concentration of inflammatory markers

Full Information

NCT ID

NCT03450655

First Posted

February 16, 2018

Last Updated

February 28, 2018

Sponsor

Region Västerbotten

Collaborators

Umeå University

1. Study Identification

Unique Protocol Identification Number

NCT03450655

Brief Title

Cardio Training of Older Adults With Central Obesity

Official Title

Cardio Training of Older Adults With Central Obesity

Study Type

Interventional

2. Study Status

Record Verification Date

February 2018

Overall Recruitment Status

Unknown status

Study Start Date

February 9, 2018 (Actual)

Primary Completion Date

September 28, 2018 (Anticipated)

Study Completion Date

September 28, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Region Västerbotten

Collaborators

Umeå University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Visceral Obesity

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

The Data Analyst will also be masked.

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention Group

Arm Type

Experimental

Arm Description

Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention.

Arm Title

Control group

Arm Type

Experimental

Arm Description

Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home.

Intervention Type

Other

Intervention Name(s)

10-week aerobic exercise program

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in visceral adipose tissue mass

Description

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

Time Frame

0, 10, 20, and 31 weeks

Secondary Outcome Measure Information:

Title

Change in body composition

Description

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

Time Frame

0, 10, 20, and 31 weeks

Title

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

Time Frame

0, 10, 20, and 31 weeks

Title

Change in blood pressure (mmHg)

Description

Taken after 15 min of rest

Time Frame

0, 10, 20, and 31 weeks

Title

Change in blood-lipid profile

Time Frame

0, 10, 20, and 31 weeks

Title

Change in fasting blood glucose

Description

Veinous blood samples taken after > 4 h of fasting

Time Frame

0, 10, 20, and 31 weeks

Title

Change in isometric muscle strength

Description

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

Time Frame

0, 10, 20, and 31 weeks

Title

Change in physical capacity

Description

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

Time Frame

0, 10, 20, and 31 weeks

Title

Change in resting metabolic rate

Description

As measured by indirect calorimetry

Time Frame

0, 10, 20, and 31 weeks

Title

Change in health-related quality of life

Description

As measured by RAND-36

Time Frame

0, 10, 20, and 31 weeks

Title

Change in self-reported physical activity

Description

Assessed using IPAQ-SF

Time Frame

0, 10, 20, and 31 weeks

Title

Change in Microbiota composition

Description

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

Time Frame

0, 10, 20, and 31 weeks

Title

Change in dietary habits

Description

85 item food frequency questionnaire

Time Frame

0, 10, 20, and 31 weeks

Title

Change in concentration of inflammatory markers

Time Frame

0, 10, 20, and 31 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

70 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anna Nordström, PhD

Organizational Affiliation

Umeå University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Livsmedicin (LIFE)

City

Umeå

State/Province

Västerbotten

ZIP/Postal Code

907 36

Country

Sweden

12. IPD Sharing Statement

Citations:

PubMed Identifier

32398024

Citation

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.

Results Reference

derived

PubMed Identifier

31564841

Citation

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.

Results Reference

derived

PubMed Identifier

31012497

Citation

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.

Results Reference

derived

Links:

URL

https://www.healthyageinginitiative.com/

Description

Website of the Healthy Ageing Initiative

Learn more about this trial

Cardio Training of Older Adults With Central Obesity

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