RecruitingACTRN12622000692730

Evaluating the effectiveness of an early individualised targeted exercise protocol “STAY FIT in HOSPITAL” in preventing Hospital Associated Deconditioning

Evaluating the effectiveness of an early individualised targeted exercise protocol in preventing Hospital Associated Deconditioning as a sarcopenia intervention, a pilot randomised controlled trial of efficacy and feasibility


Sponsor

Dr Pushpa Suriyaarachchi

Enrollment

50 participants

Start Date

Jan 2, 2025

Study Type

Interventional

Conditions

Summary

Acute hospitalisation can result in significant decline in functional ability, termed hospital associated deconditioning (HAD). Older adults are most vulnerable with increased falls, increased disability with resultant institutionalisation. It is known that bed rest and immobility results in acute muscle atrophy and decrease muscle strength. Aim of the study: The aim of this “stay fit in hospital” exercise program is to introduce a very early exercise program of sufficient intensity starting within 48 hours of admission to hospital with a tailored exercise program for hospital associated deconditioning. We anticipate this program will prevent hospital associated deconditioning and significantly shorten their length of stay in hospital to enable them to return to the community safely, maintaining their functional level. We hypothesise that if we commence the rehabilitation program targeting strengthening of the muscles before the changes of deconditioning sets in, we can maintain the level of functioning during hospital stay to enable early safe discharge back to community. Specific Objectives 1. To determine the effectiveness of the “Stay Fit in Hospital” exercise intervention in preventing hospital associated deconditioning. 2. To determine the feasibility and cost-effectiveness of such a program in its implementation. 3. To determine its longer-term effects in maintaining functioning.


Eligibility

Sex: Both males and femalesMin Age: 65 Yearss

Plain Language Summary

Simplified for easier understanding

When older adults are admitted to hospital, even a few days of bed rest can cause rapid and significant loss of muscle strength and physical ability — a condition known as hospital-associated deconditioning (HAD). This functional decline can lead to falls, increased disability, longer hospital stays, and difficulty returning home. Yet standard hospital routines often keep patients in bed for long periods. This study tests a programme called "Stay Fit in Hospital," which starts an individualised exercise programme within 48 hours of admission, before significant deconditioning sets in. The tailored exercises focus on maintaining the muscle groups needed for daily activities. The study will measure whether the programme prevents functional decline, shortens hospital stays, and helps patients safely return to their usual level of activity in the community. You may be eligible if you are 65 years or older, live in the community, have been admitted to hospital for an acute medical condition, are able to walk (with or without a walking aid), and can give informed consent and follow instructions. People with new stroke symptoms, unstable heart or lung conditions, very short expected admissions, or acute bone or joint injuries causing severe pain are not eligible.

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Interventions

Intervention: tailored exercise program The patients will be randomly assigned to a tailored exercise program or to usual care. The exercise program for the intervention group will be implemented by

Intervention: tailored exercise program The patients will be randomly assigned to a tailored exercise program or to usual care. The exercise program for the intervention group will be implemented by the study physiotherapist and the assistant physiotherapist. The main focus will be on strength training (progressive resistance exercises) with an intensity enough to improve/maintain the lower limb strength. The main exercise equipment will be an electric mini pedal exercise bike Monark 881E ergometer with variable resistance. This is a portable machine and can be taken to study participants and can be easily administered whilst the participant is safely sitting down in a chair. The settings can be adjusted for progressively increased resistance (watts) and rpm can be monitored. The proposed exercise program will be be carefully chosen for the patient. The exercises can be performed sitting down or lying down in bed, which is most suited to our patient cohort. The recommendations as per the American College of Sports Medicine guidelines were followed in formulating the exercise program. The guidelines recommend using a high-intensity, low-to-moderate repetition maximum (RM), with completion of 10-15 repetitions for older and /or more frail participants. Progressive resistance training exercise using leg pedal ergometer, 5 days/week (morning session), start at 40-50% 1RM and gradually work up to 60-80% over the period of 7 days, 1 set of 10-12 repetition, 2 sets of light intensity with rest breaks of 10 minutes. Those participants unable to get out of bed or not tolerating the pedal exercise bike will be offered quadriceps strengthening exercises with weighted cuffs, progressively achieving 70-80% of 1 Repetition maximum. Dumbbells will be used to maintain upper limb strength for all participants and this will be offered as the second session of exercises (afternoon). Morning session will be about 40 minutes in duration and afternoon session about 20 minutes duration. The intervention group will also receive the usual care (once daily sit to stand practice and mobility training with the ward physiotherapist). A record of the exercises will be kept by the physiotherapists (study and usual care) as to the type of exercises, sets of repeats, intensity and duration. This will be used to monitor the acceptance and adherence to the intervention. Sample size Based on the previous studies a total of 150 patients (75 in each group) will give 90% power ) to detect a change in the FIM score at 7 days from -30 units in the usual care group to -15 units in the exercise intervention group (based on SD of 25 units which is a conservative estimate from our previous study). This allows 20% non- compliance. For this pilot study we will be aiming to recruit 50 patients using the same study protocols.


Locations(1)

Hawkesbury District Health Service - Windsor

NSW, Australia

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ACTRN12622000692730


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