Adherence for Exercise Rehabilitation in Older People Trial

NCT ID: NCT03643432

Last Updated: 2020-07-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2019-10-31

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.

Detailed Description

The design of this study, is a a two arm feasibility randomised controlled trial. 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 interview to assess acceptability of the intervention

Potential research participants will be invited to take part in the study with an invitation letter, along with the PIS and a reply slip. These will be sent out with information about their physiotherapy appointment, which they would normally receive.

After time to consider the study and ask any questions, if participants are happy to take part, an appointment will be made to take consent and collect baseline measures. This will take place at the Nuffield Orthopaedic Centre, if possible just prior to their physiotherapy appointment in order to limit disturbance to the participant. If this is not possible the appointment to collect consent and baseline data will be at a time convenient to the patient. At this appointment, signed consent will be recorded and baseline data collected. This will involve the participants completing some questionnaires.

Treatment allocation will be decided on the basis of the physiotherapist the participant is seeing. (Before the start of the study all physiotherapist taking part in the study will be randomly assigned to deliver either usual care or the intervention arm). Those participants in usual care will undergo physiotherapy as normal, the only additional thing they will be asked to do, is to complete an exercise diary for up to 12 weeks.

Those in the intervention arm will be asked to complete 4 short questions related to exercise and treatment expectations. These will be completed in the waiting room prior to the physiotherapy appointment. The participant will be assessed and given treatment as normal in physiotherapy. After they have been given an exercise programme as part of their treatment, they will be asked to complete a further 7 short questions related to the exercise programme, and their motivation and intention to undertake it. On the basis of the answers to these questions and also in addition to any discussion with the physiotherapists, one or more adherence approaches may be suggested. The approaches are 'review of exercise programme', 'review of method of delivery', 'cues', 'reminders', 'discussion of barriers and problem solving', 'motivational interviewing', 'decision balance sheets', 'behavioural contract' and 'goal setting review'. The participants in the intervention group will also be asked to complete an exercise diary for up to 12 weeks.

Participants in both groups will be followed up at 6 weeks and 12 weeks after their initial physiotherapy appointment. the follow appointment will consist of completing some questionnaires and to collect exercise diaries (12 week follow up). For the majority of participants this will be the end of the study. However a small sub-sample of participant will be invited to take part in an interview. This will last no longer than 1 hour, and will aim to explore the views of participants regarding the study, and also about trying to stick to an exercise programme. Participants will be given time to consider taking part in this additional interview, and will be asked to provide signed consent. Once they have finished the interview, they will be finished in the study.

Conditions

Geriatric; Exercise Adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Usual care

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

Group Type: ACTIVE_COMPARATOR

Usual Care

Intervention Type: 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

Exercise adherence intervention

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

Group Type: EXPERIMENTAL

Exercise adherence intervention

Intervention Type: 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.

Interventions

Exercise adherence intervention

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.

Intervention Type: BEHAVIORAL

Usual Care

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford Brookes University

OTHER

Sponsor Role: collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Room

Senior Research Physiontherapist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan F Room, MRes

Role: PRINCIPAL_INVESTIGATOR

Oxford University Hospitals NHS Trust

Locations

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT

Oxford, Oxfordshire, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 36266133 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

13594

Identifier Type: -

Identifier Source: org_study_id