Feasibility of Additional Physiotherapy for Patients Aged 75 and Older

Phase 2

Terminated

• Conditions: Exercise; Hospitalisation; Older Adults
• Interventions: Other: Stretching exercises; Other: Strengthening exercises

• Registration Number: NCT04144634
• Lead Sponsor: Cambridge University Hospitals NHS Foundation Trust

Brief Summary

On average, people become physically weaker during even a short stay in hospital. This study is a feasibility/pilot study to see if additional physiotherapy exercises undertaken in hospital is feasible and acceptable to patients.

The study will compare two different types of physiotherapy exercise. Both exercise programmes involve twice-daily physiotherapy provided by one of the hospital's physiotherapy assistants, but only one of the two exercise programmes expected to provide benefit. This is on top of the care that people would normally receive, and will last for the first 7 days of their hospital admission (or until they are discharged if this is earlier).

Patients will be asked to consent to the study during the first 36 hours of their hospital admission. If patients provide consent, they will undergo a baseline assessment of their functional ability (including testing of their muscle strength) before being randomly assigned to one of the two exercise programmes. The study aims to recruit 15 patients to each group (30 in total).

Once randomised patients will be seen twice a day by a physiotherapy assistant who will supervise the exercise programme.

On the day that participants are discharged (or day 7 of their admission if earlier) the assessor will repeat measures of the participants functional ability. Following these measures participants will be invited to be interviewed to discuss their experience of taking part in the study.

Approximately one month after discharge, a researcher will visit the participant to repeat measures of their functional ability at their home.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study Start: 2019-10-29
• Study First Posted: 2019-10-30
• Primary Completion: 2020-04-01
• Study Completion: 2020-04-01
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.

Exclusion Criteria

• Admitted more than 36 hours prior to recruitment; unable to provide informed consent (e.g. due to dementia, delirium, cognitive impairment); receiving end of life care or oncological treatment for diagnosed cancer; inability to cooperate in muscle strength testing (e.g. unable to sit in chair, or presence of skin integrity problems contraindicating the use of a hand-held dynamometer); transferred to or from the intensive care unit; bed-bound or requiring a hoist to transfer from bed to chair 2 weeks prior to hospitalisation; or if the Consultant in charge of the patient has any other clinical concerns regarding participation in a strengthening exercise programme.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control/Stretching	Stretching exercises	-
Intervention/Strengthening	Strengthening exercises	-

Primary Outcome Measures

Name	Time	Method
Topic-guided interview of participants at discharge from hospital	At day 7 of hospitalisation (or at discharge if earlier)

Secondary Outcome Measures

Name	Time	Method
Barthel Index	6 weeks after discharge	Scale from 0-100, 100 representing highest functional ability
Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention	At day 7 of hospitalisation (or at discharge if earlier)
de Morton Mobility Index	At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge	Scale from 0-100, 100 representing highest functional ability
Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument	6 weeks after discharge	A continuous scale, with a higher number representing a higher degree of frailty
Hand held dynamometry (Knee extension + grip strength)	At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge
Falls Efficacy Scale International	6 weeks after discharge	Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling
Confidence measured on a visual analogue scale	6 weeks after discharge	Scale from 0-100, 100 representing highest level of confidence.
Mini-Addenbrookes Cognitive Examination	6 weeks after discharge	Scale from 0-30, 30 representing highest cognitive ability.
Physical activity in hospital	6 weeks after discharge	Measured with accelerometers

Trial Locations

Locations (1)

Cambridge University Hospital NHS Foundation Trust; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom