None listed
Conditions
Brief summary
This is a pilot randomised controlled trial for recently discharged patients who are malnourished or at risk of malnutrition to receive a combined nutrition and exercise intervention at home. The control group will receive usual care (paper-based patient education materials) whilst the intervention group will receive personalised nutrition and exercise education for a 12 week period delivered by a digital app into their home. The research assistant who conducts baseline and the 12 week assessment will remain blinded to the group allocation. Outcome measures are: recruitment rate, dropout rate, nutrition and exercise adherence, and app engagement. Ten intervention group participants will also be invited to contribute to an interview at the conclusion of the intervention to obtain qualitative information on the app and intervention acceptability. All interviews (approx. 30mins each interview) will be completed using Zoom teleconference. The interview will be audio-recorded, and transcribed by a professional transcription service.
Interventions
The nutrition and exercise intervention will be delivered remotely to participants in their home for 12 weeks. The intervention will be delivered using the pre-existing commercial smartphone platform Physitrack. The system allows for development of customised video clips and text to deliver the exercise and nutrition components of the intervention in this trial. The nutrition content has been developed by the research team for deliver via the Physitrack system; the exercise component will use content already available within this system. Nutrition video clips focus on increasing energy and protein intake through fortifying pre-existing meals, adding high energy/protein meals, snacks and drinks to meet estimated energy and protein requirements. Clips include education sessions spoken to camera, whilst other content will provide practical food demonstrations (eg. how to prepare fortified milk at home). These will be personalised for each participant, with dietary changes aiming to reach the European Society for Parenteral and Enteral Nutrition requirements (25–30 kcal/kg and 1.5 g/kg ideal body weight). At least 2 personalised nutrition clips will be prescribed based on requirements per participant per week, these will be allocated weekly. The duration of these clips is 5-20minutes and participants will be encouraged to view the allocated clips each week. The nutrition clips include instruction on specific nutrition interventions, eg. How to make high energy high protein milk, why full fat yoghurt is a better choice than “diet” yoghurt, how to fortify meals through adding cheese, milk powder etc. These clips will be personalised for participants through allocation by an Accredited Practising Dietitian. Personalised messages and surveys may be sent through Physitrack to evaluate adherence and engagement. A 30-minute, home-based exercise program, personalised for each participant by an Accredited Exercise Physiologist, will be delivered by Physitrack as per American College of Sports Medicine (ACSM) guidelines for chronic health conditions. The protocol will deliver two exercise sessions per week for the first four weeks, three session per week for the second four weeks, and four sessions per week for the final four weeks. Exercise clips will focus on strength, balance and aerobic exercises. It is anticipated that for most participants, resistance exercises will be body weight supported. The strength training exercise prescription will involve functional strength training exercises for the upper and lower body (e.g. sit to stand, calf raise, wall push up, step ups) using body weight only. Participants will be prescribed a three set of 10 repetition per exercise set at a moderate intensity of self-perceived exertion using the modified rating of perceived exertion scale scale (RPE) 3-6 on the 10-point modified RPE scale. The balance component involved static and dynamic balance (e.g. standing eyes open, feet together, tandem walking) with one repetitions of each balance exercise prescribed for 30 seconds at moderate intensity (3-6 on the 10-point modified RPE scale). The aerobic component of the exercise component will involve up to 10 minutes of walking in the community at moderate intensity (3-6 on the 10-point modified RPE scale). Following each exercise, the Physitrack software will 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 Phyitrack database, enabling the exercise physiologist to review and modify or progress exercise prescriptions as required. Ten participants for the qualitative interviews will be chosen at random from the 25 participants in the intervention group. The website https://www.random.org/sequences/ will be used for randomisation. Where any decline, the next participant will be chosen, until 10 interviews are complete. The Braun & Clarke thematic analysis will be used to analyse the data. Through this approach, codes will be grouped and summarised, with thematic maps drawn to realise connections and patterns in the data. Two investigators from the research team will compare content and themes. Any disagreement will be resolved by consensus moderation.
Sponsors
Study design
Eligibility
Inclusion criteria
Participants will be community living older adults who are at risk of malnutrition (identified by a malnutrition screening tool (MST) greater than or equal to 3), or are diagnosed in the medical record by Western Health dietitians as being malnourished. They will have received care by a dietitian within the heterogenous range of healthcare services (including subacute, oncology and post-surgery services) offered at Western Health. Participants will not have chronic kidney disease as this may contra-indicate the dietary advice provided. Participants should be planning to be at home for at least 8 weeks during the enrolment period; able to communicate in English; do not have a 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 Physitrack or performing unsupervised exercise and dietary intervention safely. Participants also 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. Participants will have access to home internet.
Exclusion criteria
1. Discharged greater than 1 month ago 2. Expect to be away for 4 weeks or more during the intervention 3. Has chronic kidney disease 4. Unable to exercise safely in a home environment