Clinical trial NCT04144634: Feasibility of Additional Physiotherapy for Patients Aged 75 and Older
Official title: Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Exercise
Hospitalisation
Older Adults
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: University of Cambridge
name: University of Dublin, Trinity College
name: The Dunhill Medical Trust
name: Addenbrooke's Charitable Trust
First posted: 2019-10-30
Enrollment: 15
Sex: ALL
Minimum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Topic-guided interview of participants at discharge from hospital
timeFrame: At day 7 of hospitalisation (or at discharge if earlier)
Secondary outcomes:
measure: Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention
timeFrame: At day 7 of hospitalisation (or at discharge if earlier)
measure: Hand held dynamometry (Knee extension + grip strength)
timeFrame: At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge
measure: de Morton Mobility Index
timeFrame: At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge
measure: Barthel Index
timeFrame: 6 weeks after discharge
measure: Falls Efficacy Scale International
timeFrame: 6 weeks after discharge
measure: Confidence measured on a visual analogue scale
timeFrame: 6 weeks after discharge
measure: Mini-Addenbrookes Cognitive Examination
timeFrame: 6 weeks after discharge
measure: Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument
timeFrame: 6 weeks after discharge
measure: Physical activity in hospital
timeFrame: 6 weeks after discharge
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
References: