Cardio Training of Older Adults With Central Obesity

Study Overview
=================
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.

Official Title
-----------------
Cardio Training of Older Adults With Central Obesity

Conditions
-----------------
Visceral Obesity

Intervention / Treatment
-----------------
* Other: 10-week aerobic exercise program


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Group<br>Weeks 1-10: exercise program in group. Weeks 11-20: no intervention. Weeks 21-31: no intervention. | Other: 10-week aerobic exercise program<br>* An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.<br>|
| Experimental: Control group<br>Weeks 1-10: no intervention. Weeks 11-20: no intervention. Weeks 21-31: exercise program at home. | Other: 10-week aerobic exercise program<br>* An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in body composition | 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) |  | 0, 10, 20, and 31 weeks | 
| Change in blood pressure (mmHg) | Taken after 15 min of rest | 0, 10, 20, and 31 weeks | 
| Change in blood-lipid profile |  | 0, 10, 20, and 31 weeks | 
| Change in fasting blood glucose | Veinous blood samples taken after > 4 h of fasting | 0, 10, 20, and 31 weeks | 
| 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 | 
| Change in physical capacity | Measured using Åstrands Submaximal Test, performed on an electrically braked ergometer bicycle | 0, 10, 20, and 31 weeks | 
| Change in resting metabolic rate | As measured by indirect calorimetry | 0, 10, 20, and 31 weeks | 
| Change in health-related quality of life | As measured by RAND-36 | 0, 10, 20, and 31 weeks | 
| Change in self-reported physical activity | Assessed using IPAQ-SF | 0, 10, 20, and 31 weeks | 
| Change in Microbiota composition | Fecal samples are taken and bacterial DNA is sequenced to determine bacterial composition | 0, 10, 20, and 31 weeks | 
| Change in dietary habits | 85 item food frequency questionnaire | 0, 10, 20, and 31 weeks | 
| Change in concentration of inflammatory markers |  | 0, 10, 20, and 31 weeks |