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The Exercise for the Prevention of Falls in Older Adults with Sarcopenic Obesity Pilot Study (ESPRESSO-P).

The Exercise for the Prevention of Falls in Older Adults with Sarcopenic Obesity Pilot Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618000192280
Acronym
ESPRESSO-P Study
Enrollment
6
Registered
2018-02-07
Start date
2018-05-29
Completion date
2021-12-20
Last updated
2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

"Sarcopenia" describes the age-related decline in skeletal muscle mass and function which contributes to increased risk of disability and loss of independence. In the presence of obesity, these effects may be exacerbated, and we have demonstrated that the "sarcopenic obese" population have increased risk for falls and fractures. We hypothesise that targeted exercise can significantly improve muscle strength, balance and bone health in sarcopenic obese older adults. We will test this hypothesis by conducting a pilot randomised controlled trial (RCT) of a multi-component exercise intervention in 56 obese older adults with poor physical performance. The findings from this pilot RCT will contribute to the development of guidelines for exercise in obese older adults at increased risk for falls and fractures.

Interventions

Participants will be randomly allocated to an exercise program or lifestyle education (control). Exercise group participants will be prescribed a 24-week, individual home-based intervention modelled on the successful “Lifestyle integrated Functional Exercise (LiFE)” falls prevention program. LiFE training focuses on instituting new habitual behaviours within selected situational contexts that serve as prompts for action. Rather than a prescribed set of exercises conducted several times a week,

Participants will be randomly allocated to an exercise program or lifestyle education (control). Exercise group participants will be prescribed a 24-week, individual home-based intervention modelled on the successful “Lifestyle integrated Functional Exercise (LiFE)” falls prevention program. LiFE training focuses on instituting new habitual behaviours within selected situational contexts that serve as prompts for action. Rather than a prescribed set of exercises conducted several times a week, in the LiFE approach, movements targeting improved balance and/or strength are embedded within everyday activities, so that they can be done multiple times during the day. For example, a prescribed activity targeting the balance strategy of “reducing base of support” includes a tandem stand while working at a kitchen bench, which can be progressed to working while standing on one leg. The LiFE program will be modified for the present study to incorporate a moderate-intensity ambulatory exercise program and moderate impact, weight-bearing exercises, which have demonstrated effectiveness in improving functional capacity and femoral neck and lumbar spine BMD, respectively. Weight-bearing impact exercises will be completed daily for 24 weeks. Exercises will take 10-15 minutes to complete, and training intensity will be progressively increased. The moderate-intensity ambulatory exercise program will have weekly targets that can be completed over 2-4 days during the week, depending on participant's initial level of fitness. This will be progressively increased over 24 weeks. The modified LiFE program (ESPRESSO-P) will be taught in seven home visits by a trainer (member of study staff with experience in delivering exercise programs) in the first 12-week period of the intervention and fortnightly follow-up phone calls during the second 12-week period. Positive reinforcement from the trainer, participant goal-setting and self-monitoring, and other strategies are used to enhance self-efficacy and adherence in the later twelve weeks. All exercises will be individually-tailored, considering initial fitness, injuries or illness. Participants will also be asked to complete the physical activity diary during each week of the training phase to determine adherence to the home-based exercise protocol.

Sponsors

Dr. David Scott
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Prospective participants must be aged 60 years or older; have a body fat percentage more than or equal to 30 (men) or more than or equal to 40 (women); a Short Physical Performance Battery (SPPB) score less than or equal to 11 out of 12; willing, and has GP approval to complete a 24-week exercise intervention; and also be willing to participate should they be randomised to either intervention arm.

Exclusion criteria

Participants are ineligible if they currently reside in a nursing home; are unable to walk 400m in 15 minutes without use of walking aids; are non-English speaking or have difficulty communicating with study personnel due to speech or hearing problems; have moderate or severe cognitive impairment defined as a Mini-Mental State Exam (MMSE) score less than or equal to 18 points out of 30; report consuming more than 14 alcoholic drinks per week; report more than or equal to 4 weeks self-reported participation in a supervised exercise program targeted at weight loss or strength gains in the past six months; are planning to be away from home for more 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 a joint replacement) that would interfere with ability to complete functional 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; and any other disorder of such severity that life expectancy is less than 12 months. Temporary exclusion criteria will include hip or knee replacement, spinal surgery, stroke, myocardial infarction, major heart surgery, deep vein thrombosis, or pulmonary embolus in the past 6 months.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026