Title: Chin Tuck Against Resistance with Feedback: Swallowing Rehabilitation in Frail Older People (CTAR-SwiFt) - A feasibility study
Funder: Department of Health and Social Care

Abstract: Introduction: It is well-known that frail patients who are admitted to hospital can have particular difficulty in swallowing (pharyngeal dysphagia). Therapeutic rehabilitation exercises can improve swallowing ability and oral intake by strengthening the suprahyoid muscles involved in laryngeal elevation and anterior movement and upper oesophageal sphincter opening. The Shaker manouvre was developed to assist in strengthening these muscles, more recently the Chin Tuck Against Resistance &ndash; CTAR has been developed. This technique involves compressing a rubber ball between the chin and suprasternal notch and was shown to be just as effective in exercising the suprahyoid muscles and easier to undertake. However, there have not been studies that have explored the use of the CTAR in clinical populations. Also, there is no ability to monitor the intensity at which CTAR is performed. Therefore, there is a need for a device and an exercise programme that would allow the CTAR to be performed in a regulated way (eg rubber ball with biofeedback- 'Exerphager') by patients who are frail, such that it improves swallowing, eating and drinking. Aim: The aim of this project is to develop Biofeedback-regulated Isometric Training Exercises for Swallowing (BITES), which will be based on the CTAR technique, and which can be tested for appropriateness and effectiveness in frail older people. This is a feasibility study. Method: This study will involve three arms. 60 patients will be randomised between a control arm (usual care) and two low intensity (30%maximum) exercise programmes (Ex1 and Ex2) to explore the most suitable exercise format (once a day vs twice a day). Videofluoroscopy will be undertaken at Day 0 and Day 84 (week 24) to investigate the physiological effect of the 'Exerphager'. Clinical assessments will be undertaken at Day 0, Week 12, 16, 18 and 24 to identify the most appropriate outcome measures to evaluate the effects of the BITES programme on swallowing and to assist in determining the number of people required for a full study. The study will also explore the feasibility of the BITES intervention programme as quantified by willingness of patients to be recruited to and retained in the study ( Results: The feasibility of the BITES intervention programme will be evaluated by the research team and according to willingness of patients to be recruited and patient successful completion of the intervention (including baseline and post-intervention videofluoroscopy) in a small scale feasibility study (n=60). The null hypotheses: (i) Patients are not willing to be recruited to the BITES intervention and the intervention cannot be successfully completed by patients, and (ii) Videofluoroscopy is not acceptable to patients, as a pre- post-intervention quantitative outcome measure. Dissemination of findings: We aim to publish our findings in peer-reviewed medical journals. We will disseminate our findings via public meetings, conference presentations, NHS-sponsored workshops and media publicity.

Lay abstract: Often, as people get older, their muscles get weaker. The muscles involved in swallowing also weaken sometimes. This can result in difficulties eating and drinking and it can sometimes lead to pneumonia. Research has shown that exercise can reduce the weakening of muscles. A similar effect may occur in the swallowing muscles. At present the most common exercise for the swallowing muscles involves pressing the chin onto a ball. This exercise is done daily for 12 weeks. However, there is no way of making sure that people are doing this exercise at the right level of effort (not too hard and not too easy) and for the right length of time. Also, people can t see whether they are improving, because there is no way to keep track of their progress so that they can see it. We have developed a new simple exercise system. This can make sure that people are doing the exercises at the right level of effort and for the right length of time. This is done by using an air filled ball. As the chin is pressed into it, a series of lights will light up on a screen (for example on a mobile phone). This allows the user to make sure that they are exercising at the right level. It also records the level of effort and length of time of the exercises. This is displayed so that the person can see their progress and what they have achieved. The main purpose of the exercise programme, with this new system, is to enable people to eat and drink with less difficulty when swallowing, thereby vastly improving their quality of life. We want to find out whether people are happy to use this new exercise system. To do this, we will invite older patients to try out the exercises in hospital and at home. We will do some tests before and after the exercise programme, so that we can see whether it improves the swallowing muscles. We will measure the strength of the swallowing muscles by using a chin squeeze test . We will also x-ray the throat, as people eat and drink, to see precisely whether their swallowing is improving. This is called videofluoroscopy. We also want to see if people are willing to take part in this project; and whether they can complete the exercises, for the whole 12 weeks. After the end of the exercise programme and tests, we will ask participants how they found the exercise system; and whether they think it is suitable for use by other patients.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS;ORAL AND GASTROINTESTINAL