RecruitingACTRN12621000236897

Assessing effectiveness of Weight loss and Exercise programs for older adults with Sarcopenic Obesity delivered via MobilE application/s

The effect of a dietary intervention combined with functional intensity training delivered by mobile application on physical function, bone quality, and insulin sensitivity in older adults with sarcopenic obesity


Sponsor

Deakin University

Enrollment

116 participants

Start Date

Feb 2, 2022

Study Type

Interventional

Conditions

Summary

Sarcopenic obesity (the presence of low muscle mass/strength and high body fat) is associated with increased falls and fracture risk in older adults. Functional intensity training may reduce falls and fracture risk in sarcopenic obesity. Participants will be randomised allocated to either a home-based program or home based aerobic exercise control group while undergoing a dietary weight loss program. The project will investigate whether a 24 week home based functional impact training program results in significant improvements in physical function, bone quality and insulin sensitivity compared with home based aerobic exercise program (control) in 116 sarcopenic obese community dwelling older adults undergoing weight loss through dietary intervention.


Eligibility

Sex: Both males and femalesMin Age: 60 YearssMax Age: 89 Yearss

Plain Language Summary

Simplified for easier understanding

Sarcopenic obesity is when a person has both low muscle mass or strength and excess body fat — a combination that becomes increasingly common with age and significantly raises the risk of falls, fractures, and loss of independence. This study, called AWESOME, is testing whether a home-based exercise program using a mobile app can improve muscle strength, bone quality, physical function, and metabolic health in older adults with this condition. Participants aged 60 to 89 will be randomly assigned to either a functional impact training program (including resistance exercises and some impact activities) or a home-based aerobic exercise program. Both groups will also follow a dietary weight-loss program over 24 weeks. The exercise programs are delivered through a smartphone app called Physitrack. To be eligible, you need to be aged 60–89, have a BMI of 30 or above, score 2 or more on a muscle screening questionnaire (SARC-F), be able to walk unaided, and own a smartphone with internet access. If you have recently had a joint replacement, are on a weight-loss medication, or have a serious heart or lung condition, you may not qualify. This study offers an accessible, technology-supported way to tackle a common but under-recognised health problem in older Australians.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

During the 24-week intervention period, all participants will follow the dietary intervention, and equal numbers will be randomised to either home-based Functional Intensity Training (FIT) or home-bas

During the 24-week intervention period, all participants will follow the dietary intervention, and equal numbers will be randomised to either home-based Functional Intensity Training (FIT) or home-based aerobic exercise (control) as described below All participant’s diet will be modified by deducting 750 - 1000 kcal from their habitual intake, aiming for at least ~1.0 kg reduction in total body fat per week. Each participant will be oriented via an initial 30-40 minutes telephone consult by the study dietitian on how to quantify their intake using portion sizes and guides (i.e. balanced plate, household measures e.g. measuring cups and weight) and replacing energy-dense foods with those of lower energy density by tailoring their intake to reduce 2.1 MJ/day for a weight loss of 0.5-1kg per week. Appropriate dietary information will be selected by the dietitian using the clinician interface in Physitrack and individually broadcast to participants smart phone via the clinician interface in Physitrack at specified times throughout the day, using video demonstrations, and audio and written instructions designed by study investigators specifically for this study. Following each dietary advice, the Physitrack will broadcast questions to determine whether the participant adhered to the kilojoule reduction intervention. Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the dietitian to review weekly and modify or progress the information as required. The study dietitian will also conduct follow up telephone interviews for 20 minutes once a fortnight for weeks 2, 4, 6 and 8, and reducing the follow up calls to monthly (weeks 12, 16 and 20) throughout the intervention to monitor and review dietary intakes and set behavioural goals. In total there will be 16 dietary videos, 1 initial phone consult and 7 follow up phone consults throughtout the intervention. Participants allocated to the FIT group in the present study will be given a structured 24-week, 30-minute, home-based FIT program delivered by a commercial telehealth platform Physitrack. However, each participant is also able to complete their exercise program at a local gymnasium at their own expense. All exercises will be individually-tailored and progressive, considering initial fitness, injuries or illness. Appropriate activities will be selected by the exercise physiologists using the clinician interface in Physitrack and individually broadcast to participants smart phone via the clinician interface in Physitrack at specified times throughout the day, using video demonstrations, and audio and written instructions designed by study investigators specifically for this study. Following each exercise, the Physitrack will broadcast questions to determine whether the participant completed the exercise, their self-perceived exertion, and any concerns (e.g. Pain, dizziness). Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the exercise physiologist to review weekly and modify or progress exercise prescriptions as required. The prescribed exercise program will use body weight or additional resistance such as weight plates, dumbbells, theraband, weight vests etc if the participant has access to them unless contraindicated. In each session, participants will perform 1 set of 10 repetitions of five exercises (1 strength-focused, 1- balance-focused, and 3 impact-focused) at a low intensity of approximately 1-3 on the 10-point modified Rating of Perceived Exertion (RPE) scale to serve as a warm-up as required. Participants will be then required to perform 5 sets of 10-20 repetitions, at a moderate-intensity of approximately 4-6 on the 10-point modified Rating of Perceived Exertion (RPE) scale. Each participant will be encouraged to increase the load of all the prescribed exercises each session while maintaining the desired intensity if able. The protocol will initially deliver three exercise sessions per week for the first eight weeks of the intervention, four exercise sessions per week for the second eight weeks, and five exercise sessions per week for the final 8 weeks.


Locations(1)

Monash Medical Centre - Clayton campus - Clayton

VIC, Australia

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ACTRN12621000236897


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