Feasibility of Additional Physiotherapy for Patients Aged 75 and Older (Stand-UP)

Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation

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.

Study Overview

• Status: Terminated
• Conditions: Exercise; Older Adults; Hospitalisation
• Intervention / Treatment: Other: Strengthening exercises; Other: Stretching exercises

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2

Contacts and Locations

Study Locations

• United Kingdom
  • Cambridgeshire
    • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
      • Cambridge University Hospital NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 75 years and older (OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention/Strengthening	Other: Strengthening exercises; The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of progressive resistance training based around the movement of standing up/sitting down.
SHAM_COMPARATOR: Control/Stretching	Other: Stretching exercises; The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cambridge University Hospitals NHS Foundation Trust
• Collaborators: University of Cambridge; University of Dublin, Trinity College; The Dunhill Medical Trust; Addenbrooke's Charitable Trust

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 29, 2019
• Primary Completion (ACTUAL): April 1, 2020
• Study Completion (ACTUAL): April 1, 2020

Study Registration Dates

• First Submitted: October 28, 2019
• First Submitted That Met QC Criteria: October 28, 2019
• First Posted (ACTUAL): October 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 14, 2021
• Last Update Submitted That Met QC Criteria: January 12, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: A095191; 252802 (OTHER: IRAS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No