Authors
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Deakin University -More
Category
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Primary study
Registry of Trials»ANZCTR
Year
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2021
INTERVENTION: 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 minutes telephone consult by the study dietician on how to quantify their intake using food models and measuring utensils, as well as on how to reduce food portion sizes and replacing energy‐dense foods with those of lower energy density. Appropriate dietary information will be selected by the dietician 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 calorie reduction intervention. Participants’ responses to these questions will be recorded and saved to the Physitrack database, enabling the dietician to review weekly and modify or progress the information as required. The study dietician will also conduct telephone interviews for 30 minutes every 2 weeks throughout the intervention to monitor and review dietary intakes and set behavioural goals. 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 CONDITION: Diet and Nutrition ‐ Obesity Musculoskeletal ‐ Other muscular and skeletal disorders Sarcopenic Obesity; ; Sarcopenic Obesity PRIMARY OUTCOME: Change in Muscular Power (Vertical Jump (W/kg) as assessed by a Leonardo Mechanography Ground Reaction Force Platform[Baseline, follow‐up (24 weeks post‐intervention commencement)] ; [Baseline, 12 weeks and 24 weeks post‐intervention commencement] Quality of Life as assessed by EuroQol‐5D‐5L ; [Baseline, 12 weeks and 24 weeks post‐intervention commencement] Quality of life for people with sarcopenia as assessed by Sarcopenia Quality of Life ; INCLUSION CRITERIA: Prospective participants must be aged 65‐89 years; English‐speaking; have a body mass index greater than or equal to 30 kg/m2, score 4 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. SECONDARY OUTCOME: 25‐hydroxyvitamin D as assessed by 10mL fasting blood sample taken by a qualified technician[Baseline, follow‐up (24 weeks post‐intervention commencement)] Anterior‐posterior spine bone mineral density (T‐score) as assessed by a dual‐energy X‐ray absorptiometry[Baseline, follow‐up (24 weeks post‐intervention commencement)] C‐Reactive protein as assessed by 10mL fasting blood sample taken by a qualified technician [Baseline, follow‐up (24 weeks post‐intervention commencement)] Falls efficacy as assessed by Modified Falls Efficacy Scale [Baseline, 12 weeks and 24 weeks post‐intervention commencement] Glucose as assessed by 10mL fasting blood sample taken by a qualified technician[Baseline, follow‐up (24 weeks post‐intervention commencement)] Hand Grip Strength (kg) as assessed by a Jamar hydraulic hand grip dynamometer[Baseline, follow‐up (24 weeks post‐intervention commencement)] HDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician[Baseline, follow‐up (24 weeks post‐intervention commencement)] Insulin as assessed by 10mL fasting blood sample taken by a qualified technician[Baseline, follow‐up (24 weeks post‐intervention commencement)] LDL cholesterol as assessed by 10mL fasting blood sample taken by a qualified technician [Baseline, follow‐up (24 weeks post‐intervention commencement)] objective assessment of physical activity as assessed by actigraph wGT9XLink accelerometer. Physical activity data measured will be steps/day, moderate and vigorous activity.[Baseline, 12 weeks and 24 weeks post‐intervention commencement] Objective assessment of sedentary time will be assessed by actigraph wGT9XLink accelerometer. Sedentary data will be sedentary time.[Baseline, 12 weeks and 24 weeks post‐intervention commencement] objective assessment of sleep time will be assessed by actigraph wGT9XLink accelerometer. Sleep data measured will be sleep time[Baseline, 12 weeks and 24 weeks post‐intervention commencement] Physical performance and disability as assessed by the Short Physical Performance Battery[Baseline, follow‐up (24 weeks post‐intervention commencement)] Quality of life as assessed by CDC Healthy Days Questionnaire ; [Baseline, 12 weeks and 24 weeks post‐intervention commencement] Stair climb power as assessed by the Stair Climb Power Test (min)[Baseline, follow‐up (24 weeks post‐intervention commencement)] Total body bone mineral density (T score) as assessed by a dual‐energy X‐ray absorptiometry[Baseline, follow‐up (24 weeks post‐intervention commencement)] Total body fat percentage as assessed by a dual‐energy X‐ray absorptiometry[Baseline, follow‐up (24 weeks post‐intervention commencement)] Total hip bone mineral density (T‐score) as assessed by a dual‐energy X‐ray absorptiometry[Baseline, follow‐up (24 weeks post‐intervention commencement)] Total tibial bone mineral density as assessed by a High‐resolution Peripheral Quantitative Computed Tomography[Baseline, follow‐up (24 weeks post‐intervention commencement)] Triglycerides as assessed by 10mL fasting blood sample taken by a qualified technician[Baseline, follow‐up (24 weeks post‐intervention commencement)] Type 1 C‐Telopeptide as assessed by 10mL fasting blood sample taken by a qualified technician [Baseline, follow‐up (24 weeks post‐intervention commencement)] Type 1 Procollagen N‐Terminal as assessed by 10mL fasting blood sample taken by a qualified technician [Baseline, follow‐up (24 weeks post‐intervention commencement)]
Epistemonikos ID: f53429b17501269f8ef6138c65ee454cb193d990
First added on: Aug 25, 2024