Promoting Increased Physical Activity in Hospitalised Older Adults

NCT06017934 | Recruiting

• 1 other identifier: ERGO 84163
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hospital-associated Deconditioning

Keywords

Physical activity; Hospital-associated deconditioning; Sedentary behaviour; Physical inactivity; Volunteer-led; Feasibility; Implementation

Outcome Measures

Primary Outcomes (8)

• 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.

  through intervention completion, an average of 2 months

• The number of volunteers recruited to the study (%).

  Feasibility of recruiting volunteers to deliver the physical activity intervention at each hospital site

  through study completion, an average of 3 years

• Number of trainers trained in each hospital site (%)

  Feasibility of recruiting therapists to deliver the intervention at each hospital site.

  through study completion, an average of 3 years

• Adherence to the intervention (%)

  The number of participants retained in the intervention at each hospital site.

  through study completion, an average of 3 years

• Recruitment rate (%) of participants in each site

  Feasibility of recruiting older adults onto the volunteer-led physical activity intervention at each hospital site.

  through study completion, an average of 3 years

• The number of volunteers trained at the end of the study period (%)

  Feasibility of training volunteers to deliver the physical activity intervention at each hospital site

  through study completion, an average of 3 years

• The number of volunteers retained at the end of the study period (%)

  Feasibility of retaining volunteers to deliver the physical activity intervention at each hospital site

  through study completion, an average of 3 years

• Number of trainers retained in each hospital site (%)

  Feasibility of retaining therapists to deliver the intervention at each hospital site.

  through study completion, an average of 3 years

Secondary Outcomes (5)

• Patient's subjective assessment of quality of life - visual analogue scale (VAS)

  Baseline and post intervention, an average of 2 months

• Grip strength

  Baseline and post intervention, an average of 2 months

• Short Physical Performance Battery (SPPB)

  Baseline and post intervention, an average of 2 months

• Physical activity

  7 days upon recruitment

• Patient's subjective assessment of quality of life - EuroQol (EQ-5D-5L)

  Baseline and post intervention, an average of 2 months

Study Arms (2)

Control

NO INTERVENTION

Usual care

Volunteer-led physical activity

EXPERIMENTAL

Trained volunteers will deliver walking, or bedside exercises with hospitalised older adults twice per day.

Behavioral: Volunteer-led physical activity

Interventions

Volunteer-led physical activity BEHAVIORAL

Participants 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.

Volunteer-led physical activity

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients
• Adults aged 65 years and above
• Able to provide written informed consent
• Volunteers
• Adults aged 18 years and above
• Completed the generic clearance and training with the hospital voluntary services
• Able to provide written informed consent
• Able to communicate fluently enough in English. Fluent English is required to ensure the intervention content can be delivered clearly and thus safely to participants.

You may not qualify if:

• Patients
• Anyone with a severe cognitive impairment (MoCA less than 10)
• Patients isolated for infection control reasons
• Patients receiving end of life care
• Volunteers
• Volunteers that are unable to safely complete the exercises included in the intervention will be excluded from the study.

Sponsors & Collaborators

• University of Southampton: lead
• 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

Study Sites (2)

Frimley Park Hospital

Frimley, Surrey, GU16 7UJ, United Kingdom

RECRUITING

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

RECRUITING

Related Publications (3)

• Lim S, Ibrahim K, Dodds R, Purkis A, Baxter M, Rogers A, Sayer AA, Roberts HC. Physical activity in hospitalised older people: the feasibility and acceptability of a volunteer-led mobility intervention in the SoMoVe study. Age Ageing. 2020 Feb 27;49(2):283-291. doi: 10.1093/ageing/afz114.

  PMID: 31566671 BACKGROUND

• Meredith SJ, Roberts H, Grocott MPW, Jack S, Murphy J, Varkonyi-Sepp J, Bates A, Lim SER. Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital. BMJ Open. 2023 Mar 16;13(3):e069533. doi: 10.1136/bmjopen-2022-069533.

  PMID: 36927597 BACKGROUND

• Lim SER, Meredith S, Agnew S, Clift E, Ibrahim K, Roberts H. Evaluating the feasibility and acceptability of virtual group exercise for older adults delivered by trained volunteers: the ImPACt study protocol. BMJ Open. 2022 Feb 1;12(2):e052631. doi: 10.1136/bmjopen-2021-052631.

  PMID: 35105576 BACKGROUND

MeSH Terms

Conditions

Motor Activity; Sedentary Behavior

Condition Hierarchy (Ancestors)

Behavior

Central Study Contacts

Stephen ER Lim, PhD

CONTACT

+442381206131; s.e.lim@soton.ac.uk

Samantha J Meredith, PhD

CONTACT

07825104783; s.j.meredith@soton.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 18, 2023
• First Posted: August 30, 2023
• Study Start: June 6, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)