Cardio Training of Older Adults With Central Obesity

Visceral Obesity Clinical Trial

Official title:

Cardio Training of Older Adults With Central Obesity

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03450655
• Other study ID #: VCC-LIFE-4
• Status: Enrolling by invitation
• Phase: N/A
• First received: February 16, 2018
• Last updated: February 28, 2018
• Start date: February 9, 2018
• Est. completion date: September 28, 2018

Study information

• Verified date: February 2018
• Source: Västerbotten County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 80
• Est. completion date: September 28, 2018
• Est. primary completion date: September 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Obesity
• Obesity, Abdominal
• Visceral Obesity

Intervention

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

Locations

Country	Name	City	State
Sweden	Livsmedicin (LIFE)	Umeå	Västerbotten

Sponsors (2)

Lead Sponsor	Collaborator
Västerbotten County Council	Umeå University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visceral adipose tissue mass	Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA).	0, 10, 20, and 31 weeks
Secondary	Change in body composition	Mass (g) measured using Lunar iDXA with CoreScan application (GE Healthcare, Wauwatosa, WI, USA)	0, 10, 20, and 31 weeks
Secondary	Change in Body Mass Index (kg/m^2)		0, 10, 20, and 31 weeks
Secondary	Change in blood pressure (mmHg)	Taken after 15 min of rest	0, 10, 20, and 31 weeks
Secondary	Change in blood-lipid profile		0, 10, 20, and 31 weeks
Secondary	Change in fasting blood glucose	Veinous blood samples taken after > 4 h of fasting	0, 10, 20, and 31 weeks
Secondary	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.	0, 10, 20, and 31 weeks
Secondary	Change in physical capacity	Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle	0, 10, 20, and 31 weeks
Secondary	Change in resting metabolic rate	As measured by indirect calorimetry	0, 10, 20, and 31 weeks
Secondary	Change in health-related quality of life	As measured by RAND-36	0, 10, 20, and 31 weeks
Secondary	Change in self-reported physical activity	Assessed using IPAQ-SF	0, 10, 20, and 31 weeks
Secondary	Change in Microbiota composition	Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition	0, 10, 20, and 31 weeks
Secondary	Change in dietary habits	85 item food frequency questionnaire	0, 10, 20, and 31 weeks
Secondary	Change in concentration of inflammatory markers		0, 10, 20, and 31 weeks

External Links

•   Website of the Healthy Ageing Initiative