Clinical trial NCT03450655: Cardio Training of Older Adults With Central Obesity
Official title: Cardio Training of Older Adults With Central Obesity
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Visceral Obesity
Lead sponsor: Region Västerbotten
Sponsor class: OTHER_GOV
Collaborators: name: Umeå University
First posted: 2018-03-01
Enrollment: 80
Sex: ALL
Minimum age (years): 70
Maximum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in visceral adipose tissue mass
timeFrame: 0, 10, 20, and 31 weeks
Secondary outcomes:
measure: Change in body composition
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in Body Mass Index (kg/m^2)
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in blood pressure (mmHg)
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in blood-lipid profile
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in fasting blood glucose
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in isometric muscle strength
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in physical capacity
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in resting metabolic rate
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in health-related quality of life
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in self-reported physical activity
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in Microbiota composition
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in dietary habits
timeFrame: 0, 10, 20, and 31 weeks
measure: Change in concentration of inflammatory markers
timeFrame: 0, 10, 20, and 31 weeks
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Livsmedicin (LIFE)
state: Västerbotten
Study officials:
affiliation: Umeå University
name: Anna Nordström, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.