ExercisePhase 2Stand-UPNCT04144634
Feasibility of Additional Physiotherapy for Patients Aged 75 and Older
A Phase 2 study testing Strengthening exercises and Stretching exercises in people with Exercise and Hospitalisation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Exercise, Hospitalisation, Older Adults
- What is being tested?
- Strengthening exercises and Stretching exercises
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Oct 2019to 1 Apr 2020
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospital NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: 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).
Read more
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.
- Conditions
- Exercise, Hospitalisation, Older Adults
- Being tested
- Strengthening exercises, Stretching exercises
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strengthening exercisesOther
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.
Stretching exercisesOther
The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention/Strengthening | Experimental | Not described Receives: Other: Strengthening exercises |
| Control/Stretching | Sham comparator | Not described Receives: Other: Stretching exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Topic-guided interview of participants at discharge from hospital
Measured: At day 7 of hospitalisation (or at discharge if earlier)
Secondary outcomes (9)
Topic-guided semi-structured interview of the group of physiotherapy assistants who delivered the intervention
Measured: At day 7 of hospitalisation (or at discharge if earlier)
Hand held dynamometry (Knee extension + grip strength)
Measured: 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
Measured: 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
Measured: 6 weeks after discharge
Falls Efficacy Scale International
Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling
Measured: 6 weeks after discharge
Confidence measured on a visual analogue scale
Scale from 0-100, 100 representing highest level of confidence.
Measured: 6 weeks after discharge
Mini-Addenbrookes Cognitive Examination
Scale from 0-30, 30 representing highest cognitive ability.
Measured: 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
Measured: 6 weeks after discharge
Physical activity in hospital
Measured with accelerometers
Measured: 6 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2019
- Study start29 Oct 2019
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Why it stopped: Terminated due to COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, University of Dublin, Trinity College, The Dunhill Medical Trust, Addenbrookes Charitable Trust
- Responsible party
- Principal investigator, Peter Hartley, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04144634
- Sponsor's protocol ID
- A095191
- Other IDs
- 252802
- Acronym
- Stand-UP
- Status last verified
- Jan 2021
- First submitted
- 28 Oct 2019
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of an Exercise Programme to Maintain Knee Extension Muscle Strength for Older Patients During Hospitalisation
- ClinicalTrials.gov ID
- NCT04144634
- Acronym / sponsor ID
- Stand-UP / A095191
- Conditions
- Exercise, Hospitalisation, Older Adults
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Terminated due to COVID-19
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Cambridge, University of Dublin, Trinity College, The Dunhill Medical Trust, Addenbrookes Charitable Trust
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 30 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention/Strengthening | Experimental | Other: Strengthening exercises |
| Control/Stretching | Sham comparator | Other: Stretching exercises |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strengthening exercisesThe 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. | Other | Intervention/Strengthening |
| Stretching exercisesThe intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs. | Other | Control/Stretching |
Primary outcome
Topic-guided interview of participants at discharge from hospital
Time frame: At day 7 of hospitalisation (or at discharge if earlier)
9 secondary outcomes
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)
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
de Morton Mobility Index
Time frame: At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge
Barthel Index
Time frame: 6 weeks after discharge
Falls Efficacy Scale International
Time frame: 6 weeks after discharge
Confidence measured on a visual analogue scale
Time frame: 6 weeks after discharge
Mini-Addenbrookes Cognitive Examination
Time frame: 6 weeks after discharge
Survey of Health, Ageing and Retirement in Europe (SHARE) Frailty Instrument
Time frame: 6 weeks after discharge
Physical activity in hospital
Time frame: 6 weeks after discharge
Results and safety
The study was stopped early (reason given: Terminated due to COVID-19). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Strengthening exercises and Stretching exercises in people with Exercise and Hospitalisation, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Terminated due to COVID-19). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Topic-guided interview of participants at discharge from hospital (time frame: At day 7 of hospitalisation (or at discharge if earlier)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2021.