Plain English Summary
Background and study aims
The British Heart Foundation recommends physical activity in frail older people. Unfortunately, older patients in hospital spend the majority of their time in a sedentary state. Physical inactivity in hospital leads to poorer health outcomes. Encouraging physical activity in hospital is challenging due to a number of reasons ranging from a limited number of therapists (who usually deliver the exercise sessions), limited therapy time, older patients unable to recall exercises prescribed, lack of patient engagement and motivation; and concern of causing falls. Therefore, chair based pedal exercises offer a simple method of improving physical activity. Its repetitive nature is much easier to follow and this helps those with memory concerns. Resistance training as part of pedal exercise may improve muscle strength. All this should result in improved lower limb function. An activity that involves sitting down is more likely to reassure both patients and staff regarding the risk of falls and resulting injury. Chair based pedal exercise in addition to usual ward care may improve healthcare outcomes. We propose a study to evaluate how feasible it is to deliver regular chair based pedal exercises (the intervention) on older people (≥65 years old) admitted to an acute medical ward.
Who can participate?
People aged at least 65 admitted to an acute geriatric ward that are able to co-operate and sit in a chair on their own for at least 10 minutes
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 receive standard care, that is the care currently given on the ward. Those in group 2 receive the intervention. This includes
regular chair based pedal exercises for 5 minutes 3 times a day until they leave hospital or after 7 days, whichever comes. This is in addition to the standard care delivered. Participants are asked to pedal continuously with no pre-specified targets set, e.g. rpm or level of resistance. This exercise is initially supervised by a member of the research team and then supervised by members of the ward team. This is to replicate ‘real life’ hospital setting where exercises in hospital are initiated and observed by a therapist and the patients encouraged to continue with the exercises with support by the ward team. Participants in both groups have access to the ward physiotherapist and an inpatient therapy plan as part of their standard care. The participants also have similar access to medical, nursing and other allied healthcare staff.
What are the possible benefits and risks of participating?
Participants offered pedal exercises will be able to maintain their fitness whilst in hospital. Participating in the study will help to provide the research team with information to improve physical activity and mobility in hospital. There are no known side effects. Tiredness due to the pedal exercise is possible. Hence, if a participant suffers with any heart or lung problems, the research team would urge the participant to pace him or herself, to stop if any discomfort arises and inform the healthcare and research team. Participants may also experience mild discomfort from wearing the activity monitor with its associated dressing. If this was the case the monitor could be repositioned.
Where is the study run from?
Queens Medical Centre, Nottingham University Hospitals NHS Trust.
When is study starting and how long is it expected to run for?
October 2014 to October 2016
Who is the main contact?
Dr Terence Ong
Study website
Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
NUH R&I 14HC024
Study information
Scientific title
The effect of chair based pedal exercises for older people admitted to an acute hospital on function and mobility compared to standard care: a feasibility study
Acronym
PEDAL
Study hypothesis
Chair based pedal exercise in addition to standard care improves muscle function in older people admitted to hospital compared to standard care alone
Ethics approval(s)
NRES Committee West Midlands - Coventry & Warwickshire, ref: 15/WM/0149
Study design
Randomised feasibility trial
Primary study design
Interventional
Secondary study design
Randomised parallel trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Muscle strength of older people admitted to hospital
Intervention
There will be 2 treatment groups (standard care and intervention group).
1. Standard care is what is currently done on the ward.
2. The intervention is prescribed regular chair based pedal exercises for 5 minutes 3 times a day until discharge or 7 days, whichever comes first in addition to the standard care delivered. Participants will be asked to pedal continuously with no pre-specified targets set, e.g. rpm or level of resistance. This exercise will be supervised initially by a member of the research team with subsequent supervision by members of the ward team. This is to replicate ‘real life’ hospital setting where exercises in hospital are initiated and observed by a therapist and the patients encouraged to continue with the exercises with support by the ward team.
Both arms of the trial will have access to the ward physiotherapist and an inpatient therapy plan as part of their standard care. The participants will also have similar access to medical, nursing and other allied healthcare staff.
Intervention type
Device
Pharmaceutical study type(s)
Phase
Drug/device/biological/vaccine name(s)
Primary outcome measure
Muscle strength
Secondary outcome measures
1. Changes in mobility (Elderly Mobility Scale)
2. Physical activity (body worn accelerometers)
3. Inpatient falls
4. Discharge destination
5. inpatient and 30 day mortality
Overall study start date
29/10/2014
Overall study end date
10/10/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Older people (≥ 65 years) admitted as an emergency to an acute geriatric ward
2. Able to co-operate and able to sit in a chair independently for a continual period of at least 10 minutes
Participant type(s)
Patient
Age group
Senior
Sex
Both
Target number of participants
50
Participant exclusion criteria
1. Terminally ill or moribund
2. Need for isolation
3. Bed bound prior to admission
4. Predicted length of stay ≤48 hours
5. Unable to use the pedal exerciser due to functional impairment, e.g. lower limb fracture, lower limb pain, leg amputation, foot deformity
Recruitment start date
10/08/2015
Recruitment end date
01/04/2016
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Research and Innovation, Nottingham University Hospitals NHS Trust
Sponsor details
Queens Medical Centre
Derby Road
Nottingham
NG7 2UH
England
United Kingdom
Sponsor type
Hospital/treatment centre
Website
ROR
Funders
Funder type
Not defined
Funder name
British Geriatrics Society
Alternative name(s)
BGS
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
High impact conferences and journals.
Intention to publish date
30/04/2018
Individual participant data (IPD) sharing plan
The datasets generated during and/or analysed during the current study are/will be available upon request from Terence Ong, terenceong@doctors.org.uk. Anonymised participant level data will be available for analysis upon request.
IPD sharing plan summary
Available on request
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Basic results | 02/11/2017 | 07/12/2017 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN59443849_BasicResults_02Nov17.docx Uploaded 07/12/2017