Promoting Increased Physical Activity in Hospitalised Older Adults
ConditionHospital-associated Deconditioning
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorUniversity of Southampton
About this trial
The PIVOT study will explore the feasibility of training volunteers to deliver exercise to hospitalised older adults to improve the health of older people and prevent deconditioning while in hospital. Loss of strength and mobility (i.e., deconditioning) is common in hospitalised older people and is associated with a decline in physical function, poorer quality of life and increased health and care costs. Physical inactivity is an important and modifiable risk factor. A previous study showed it is feasible to train volunteers to engage with older people in hospital and facilitate walking and bedside exercises. The intervention was well-received by older adults, staff members and volunteers. The aim of this study is to determine the feasibility of implementing volunteer-led physical activity in three hospitals of varying sizes in different regions.
Older adults aged 65 years and above admitted to an acute hospital will be invited to participate in the study. The study aims to recruit 180 participants; 90 from three intervention sites and 90 from a control site. Participants at the intervention sites will receive a twice daily volunteer-led physical activity intervention, and participants at the control site will receive usual care.
Participants who are able to mobilise independently will perform walking exercises and individuals with mobility impairments will perform bedside exercises. The volunteers will be trained and monitored by hospital therapists. The acceptability of the intervention will be explored through interviews with patients, volunteers, and staff. Intervention feasibility will also be examined through measuring retention of trainers, volunteers, and patients on the intervention, and adherence to the exercise.
Study findings will help to determine the feasibility of the volunteer-led physical activity intervention across different sized hospitals, voluntary service teams, and therapy services to explore the implementation and roll out of the intervention across NHS sites and the development of a toolkit to support knowledge transfer.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Adults aged 65 years and above
Able to provide written informed consent
Adults aged 18 years and above
Completed the generic clearance and training with the hospital voluntary services
Disqualifiers
Anyone with a severe cognitive impairment (MoCA less than 10)
Patients isolated for infection control reasons
Patients receiving end of life care
Volunteers that are unable to safely complete the exercises included in the intervention will be excluded from the study.
Trial design
Design model
Single group
Treatments tested in this trial
Volunteer-led physical activity
BehavioralParticipants will be assessed by the therapy team who will prescribe tailored activity and then liaise with the mobility volunteers, who will deliver the intervention. Participants who can mobilise independently will be encouraged to perform walking exercises, progressing their walking distance over set markers in the hospital (e.g., to the end of the bed and back; to the doorway and back; to the toilet and back). Participants who require assistance in mobility will perform bed (e.g., hip abduction, static quads), or chair exercises (e.g., ankle pumps, knee extension, arm raise), and will be progressed to performing walking exercises when their physical function improves. Volunteers will check with nursing staff that participants are safe to exercise before each activity session. Participants will receive the mobility sessions twice daily, starting upon recruitment and continuing until the day of discharge from hospital.
Treatment groups
225 Participants
are divided into 2 treatment groupsGroup A: ControlNo intervention 0 interventions
Group B: Volunteer-led physical activityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Qualitative interview data exploring the acceptability of the intervention, including barriers and enablers to the implementation of the intervention.
Qualitative interviews will be conducted with service managers, therapy managers, patients, nurses, ward therapists, and volunteers from all study sites, to determine the acceptability of the intervention.
Time frame
through intervention completion, an average of 2 months2
The number of volunteers recruited to the study (%).
Feasibility of recruiting volunteers to deliver the physical activity intervention at each hospital site
Time frame
through study completion, an average of 3 years3
Number of trainers trained in each hospital site (%)
Feasibility of recruiting therapists to deliver the intervention at each hospital site.
Time frame
through study completion, an average of 3 years4
Adherence to the intervention (%)
The number of participants retained in the intervention at each hospital site.
Time frame
through study completion, an average of 3 yearsSecondary outcomes
1
Patient's subjective assessment of quality of life - visual analogue scale (VAS)
Quality of life will be measured using the EuroQol (EQ-5D-5L) VAS. The VAS subjectively rates health from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
Time frame
Baseline and post intervention, an average of 2 months2
Grip strength
Grip strength is a simple and accurate measure of muscle function in clinical practice. Grip strength will be measured using the Jamar hand dynamometer, the most widely used instrument in clinical practice with established test-retest, inter-rater and intra-rater reliability.
Time frame
Baseline and post intervention, an average of 2 months3
Short Physical Performance Battery (SPPB)
The SPPB is a reliable and valid measure of physical function in older people ≥ 60 years and includes exploration of three domains, including walking speed, chair stands, and three progressive balance tasks.
Time frame
Baseline and post intervention, an average of 2 months4
Physical activity
Physical activity will be measured using the StepWatch Activity Monitor (SAM; Modus health, Washington, USA), recording daily step count. The SAM is worn on the ankle and is considered an accurate measure of physical activity in older hospitalised patients that engage in low-intensity physical activity and have lower walking speeds.
Time frame
7 days upon recruitmentSponsors and contacts
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University of Southampton
Lead sponsor
National Institute for Health Research, United Kingdom
Collaborator
University of Leeds
Collaborator
Portsmouth Hospitals NHS Trust
Collaborator
Salisbury NHS Foundation Trust
Collaborator
Newcastle-upon-Tyne Hospitals NHS Trust
Collaborator
Frimley Park Hospital NHS Trust
Collaborator
Source ClinicalTrials.gov