Feasibility of Additional Physiotherapy for Patients Aged 75 and Older

NCT04144634 | Terminated Phase 2

• 2 other identifiers: A095191252802
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Exercise; Hospitalisation; Older Adults

Outcome Measures

Primary Outcomes (1)

• Topic-guided interview of participants at discharge from hospital

  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

  At day 7 of hospitalisation (or at discharge if earlier)

• Hand held dynamometry (Knee extension + grip strength)

  At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge

• de Morton Mobility Index

  At day 7 of hospitalisation (or at discharge if earlier), follow up 6 weeks after discharge

• Barthel Index

  6 weeks after discharge

• Falls Efficacy Scale International

  6 weeks after discharge

Study Arms (2)

Intervention/Strengthening

EXPERIMENTAL

Other: Strengthening exercises

Control/Stretching

SHAM COMPARATOR

Other: Stretching exercises

Interventions

Strengthening exercises OTHER

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.

Intervention/Strengthening

Stretching exercises OTHER

The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.

Control/Stretching

Eligibility Criteria

• Age: 75 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Patients admitted to CUH, who are aged 75 or older, able to give informed consent and expected to be hospitalised more than 24 hours.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cambridge University Hospitals NHS Foundation Trust: lead
• University of Cambridge: collaborator
• University of Dublin, Trinity College: collaborator
• The Dunhill Medical Trust: collaborator
• Addenbrooke's Charitable Trust: collaborator

Study Sites (1)

Cambridge University Hospital NHS Foundation Trust

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapist

Study Record Dates

• First Submitted: October 28, 2019
• First Posted: October 30, 2019
• Study Start: October 29, 2019
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: January 14, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)