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

Inclusion Criteria1

  • Prospective participants must be aged 60-89 years; English-speaking; have a body mass index greater than or equal to 30 kg/m2, score 2 greater than or equal to on the SARC-F questionnaire, able to walk across a room unaided; with access to a smartphone connected to an internet network; willing to complete a 24-week weight loss intervention and also be willing to participate should they be randomised to either intervention arm.

Exclusion Criteria1

  • Participants are ineligible if they currently reside in a nursing home; are unable to walk across a room are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; report less than or equal to 4 weeks self-reported participation in a supervised exercise or dietary program targeted at weight loss or strength gains in the past six months; taking any medication or supplements that facilitate weight loss; are planning to be away from home for less than or equal to 4 weeks during the intervention; and self-reported diagnosis of: progressive neurological disorders including Parkinson’s Disease and multiple sclerosis; schizophrenia or bipolar disorder; severe knee or hip osteoarthritis (awaiting or have had a joint replacement) that would interfere with ability to complete functional exercise and tests; cardiovascular disease (including NYHA Class III or IV congestive heart failure, clinically significant valvular disease, history of cardiac arrest, presence of an implantable cardiac defibrillator, or uncontrolled angina); lung disease requiring regular use of corticosteroids or supplemental oxygen; renal disease requiring dialysis; hyper- or hypothyroidism that would interfere with the weight loss program; and any other disorder of such severity that life expectancy is less than 12 months. or any cognitive or physical impairment or disability that in the opinion of the participant’s’ GP/specialist and/or study investigators would result in the participant having difficulty interacting with the Physitrack application or performing unsupervised exercise safely. Finally, participants must answer ‘no’ to all six questions on the Exercise and Sports Science Australia (ESSA) pre-exercise screening tool to ensure that it is safe for them to exercise at moderate exertion. This is a validated and recommended pre-exercise screening tool endorsed by Australia’s peak exercise body (ESSA).

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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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