RecruitingACTRN12618000192280

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

Sponsor

Dr. David Scott

Enrollment

56 participants

Start Date

May 29, 2018

Study Type

Interventional

Conditions

Falls Risk Sarcopenic Obesity

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.

Eligibility

Sex: Both males and femalesMin Age: 60 Yearss

Plain Language Summary

Simplified for easier understanding

This pilot study is testing whether a multi-part exercise program can help older adults who are obese and have low muscle strength or mass — a condition called sarcopenic obesity — reduce their risk of falling and fractures. Falls are a major health risk in older people, and being both obese and having weak muscles increases that risk significantly. The 24-week exercise program is being tested in 56 participants to see if it is practical to run and to gather early results on muscle strength, balance, and bone health. You may be eligible if: - You are 60 years or older - You have a body fat percentage of 30% or more (men) or 40% or more (women) - You have a Short Physical Performance Battery (SPPB) score of 11 or less (out of 12) - Your doctor has approved you to take part in a 24-week exercise program You may NOT be eligible if: - You live in a nursing home - You cannot walk 400 metres in 15 minutes without walking aids - You have moderate or severe cognitive impairment - You drink more than 14 alcoholic drinks per week - You have a serious heart, lung, neurological, or joint condition that could interfere with exercise - You have had a hip or knee replacement, stroke, or heart surgery in the past 6 months Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 modell

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.