Adherence for Exercise Rehabilitation in Older People Trial

NCT03643432 | Completed Results

• 1 other identifier: 13594
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

Exercise is an effective treatment modality for many chronic conditions. The effectiveness of prescribed exercise can be limited by adherence to exercise programmes. Older people are more likely to have a long term, or multiple long term conditions, for which exercise is a treatment option. The investigators know that exercise engagement after discharge from hospital or physiotherapy is poor in older people. In addition to this there may be specific factors that affect exercise adherence in older people. Exercise adherence interventions can be viewed as behaviour change interventions, as their aim is to change the behaviour of the patient. However many interventions lack theoretical underpinning. This study will test the feasibility of a brief behavioural assessment underpinned by the COM-B behaviour change model, in addition to targeted adherence approaches based on that assessment. Participants will be randomised between usual care, and the behavioural assessment intervention arm. Adherence to the exercise programme given in physiotherapy will be recorded in both groups at 6 and 12 weeks. Feasibility of recruitment, retention and acceptability of the intervention will also be assessed. A subsection of participants will also take part in a qualitative interview, this will explore participants experience of the trial intervention, in addition to the participants experience of attempting to adhere to an exercise programme.

Conditions

Geriatric; Exercise Adherence

Outcome Measures

Primary Outcomes (1)

• Self-reported Adherence

  This is a self-report scale ranging from 0-10, where patient will be asked to rate their adherence over the previous twelve weeks, ranging from 0 = 'no exercises performed' to 10 = 'all exercise performed as instructed'

  12 weeks

Secondary Outcomes (8)

• Exercise Adherence Rating Scale (EARS)

  6 weeks and 12 weeks

• Exercise Diary

  12 weeks

• Global Rating of Change

  6 weeks and 12 weeks

• Physical Activity Scale for the Elderly (PASE)

  6 weeks and 12 weeks

• EQ 5D 5L

  6 weeks and 12 weeks

Study Arms (2)

Usual care

ACTIVE COMPARATOR

The usual care arm will consist of routine physiotherapy treatment, without the intervention.

Behavioral: Usual Care

Exercise adherence intervention

EXPERIMENTAL

The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.

Behavioral: Exercise adherence intervention

Interventions

Exercise adherence intervention BEHAVIORAL

Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders.

Exercise adherence intervention

Usual Care BEHAVIORAL

Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm

Usual care

Eligibility Criteria

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

You may qualify if:

• Participant is willing and able to give informed consent for participation in the study
• Male or Female, aged 65 years or above
• Referred to physiotherapy with a musculoskeletal problem
• Able to converse in and read English

You may not qualify if:

• Any comorbidity that precludes exercising such as unstable angina, or acute illness
• Dementia or cognitive impairment precluding the ability to follow an exercise programme
• Patients referred to physiotherapy for post-surgery rehabilitation

Sponsors & Collaborators

• Oxford University Hospitals NHS Trust: lead
• Oxford Brookes University: collaborator

Study Sites (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT

Oxford, Oxfordshire, OX3 7HE, United Kingdom

Location

Related Publications (1)

• Room J, Dawes H, Boulton M, Barker K. The AERO study: A feasibility randomised controlled trial of individually tailored exercise adherence strategies based on a brief behavioural assessment for older people with musculoskeletal conditions. Physiotherapy. 2023 Mar;118:88-96. doi: 10.1016/j.physio.2022.08.006. Epub 2022 Aug 30.

  PMID: 36266133 DERIVED

Results Point of Contact

• Title: Jon Room
• Organization: Oxford University Hospitals NHS FT

jonathan.room@ouh.nhs.uk

01865737526

Study Officials

• Jonathan F Room, MRes

  Oxford University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Research Physiontherapist

Model Details: Participants will be randomised between usual care or the intervention arm which will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. A sub sample of the population will undergo a qualitative study to assess acceptability of the intervention.

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: July 28, 2020
• Results First Posted: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)