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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04144634
Recruitment Status : Terminated (Terminated due to COVID-19)
First Posted : October 30, 2019
Last Update Posted : January 14, 2021
Sponsor:
Collaborators:
University of Cambridge
University of Dublin, Trinity College
The Dunhill Medical Trust
Addenbrooke's Charitable Trust
Information provided by (Responsible Party):
Peter Hartley, Cambridge University Hospitals NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Exercise Hospitalisation Older Adults Other: Strengthening exercises Other: Stretching exercises Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation
Actual Study Start Date : October 29, 2019
Actual Primary Completion Date : April 1, 2020
Actual Study Completion Date : April 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Topic-guided interview of participants at discharge from hospital [ Time Frame: At day 7 of hospitalisation (or at discharge if earlier) ]

Secondary Outcome Measures :
  1. Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention [ Time Frame: At day 7 of hospitalisation (or at discharge if earlier) ]
  2. Hand held dynamometry (Knee extension + grip strength) [ Time Frame: At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge ]
  3. de Morton Mobility Index [ Time Frame: 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

  4. Barthel Index [ Time Frame: 6 weeks after discharge ]
    Scale from 0-100, 100 representing highest functional ability

  5. Falls Efficacy Scale International [ Time Frame: 6 weeks after discharge ]
    Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling

  6. Confidence measured on a visual analogue scale [ Time Frame: 6 weeks after discharge ]
    Scale from 0-100, 100 representing highest level of confidence.

  7. Mini-Addenbrookes Cognitive Examination [ Time Frame: 6 weeks after discharge ]
    Scale from 0-30, 30 representing highest cognitive ability.

  8. Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument [ Time Frame: 6 weeks after discharge ]
    A continuous scale, with a higher number representing a higher degree of frailty

  9. Physical activity in hospital [ Time Frame: 6 weeks after discharge ]
    Measured with accelerometers


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04144634


Locations
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United Kingdom
Cambridge University Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
University of Cambridge
University of Dublin, Trinity College
The Dunhill Medical Trust
Addenbrooke's Charitable Trust
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Peter Hartley, Physiotherapist, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04144634    
Other Study ID Numbers: A095191
252802 ( Other Identifier: IRAS )
First Posted: October 30, 2019    Key Record Dates
Last Update Posted: January 14, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No