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
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||15 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
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.
- Topic-guided interview of participants at discharge from hospital [ Time Frame: At day 7 of hospitalisation (or at discharge if earlier) ]
- 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 ]Scale from 0-100, 100 representing highest functional ability
- Barthel Index [ Time Frame: 6 weeks after discharge ]Scale from 0-100, 100 representing highest functional ability
- Falls Efficacy Scale International [ Time Frame: 6 weeks after discharge ]Scale from 16-64, 16 representing highest perceived self efficacy of avoiding falling
- Confidence measured on a visual analogue scale [ Time Frame: 6 weeks after discharge ]Scale from 0-100, 100 representing highest level of confidence.
- Mini-Addenbrookes Cognitive Examination [ Time Frame: 6 weeks after discharge ]Scale from 0-30, 30 representing highest cognitive ability.
- 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
- Physical activity in hospital [ Time Frame: 6 weeks after discharge ]Measured with accelerometers
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
|Cambridge University Hospital NHS Foundation Trust|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|