Adherence for Exercise Rehabilitation in Older People Trial

Not Applicable

Completed

• Conditions: Exercise Adherence; Geriatric
• Interventions: Behavioral: Usual Care; Behavioral: Exercise adherence intervention

• Registration Number: NCT03643432
• Lead Sponsor: Oxford University Hospitals NHS Trust

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.

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Study Start: 2018-09-01
• Primary Completion: 2019-10-31
• Study Completion: 2019-10-31
• Results First Submitted: 2020-06-24
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Results First Posted: 2020-07-28
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual Care	The usual care arm will consist of routine physiotherapy treatment, without the intervention.
Exercise adherence intervention	Exercise adherence intervention	The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.

Primary Outcome Measures

Name	Time	Method
Self-reported Adherence	12 weeks	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'

Secondary Outcome Measures

Name	Time	Method
Exercise Adherence Rating Scale (EARS)	6 weeks and 12 weeks	The Exercise Adherence Rating Scale is a 6 item self-report questionnaire, that asks people to record the answer to 6 question on exercise adherence, on a 5 point Likert scale. Each question is scored 0 to 4 (0 - completely agree to 4 - completely disagree), however questions 1,4 and 6 are reverse scored (4 - completely agree to 0 - completely disagree). The total score can range from 0-24. A higher score equals better adherence.
Exercise Diary	12 weeks	This diary will have been completed post physiotherapy, recording the number, sets and reps of exercises that the patient has been undertaken.
Global Rating of Change	6 weeks and 12 weeks	This is the participants' perception of their change since their initial appointment; possible scores range from -3 = 'very much worse', -2 = 'much worse', -1 = 'a little worse', 0 = 'about the same/no difference', 1 = 'a little better', 2 = 'much better', 3 = 'very much better'. Higher scores indicate a better outcome.
Physical Activity Scale for the Elderly (PASE)	6 weeks and 12 weeks	The Physical Activity Scale for the Elderly is a physical activity self-report questionnaire that takes around 5-10 minutes to complete. Different activities have been weighted as assigned by the developers of the scale. The total score for PASE is calculated by multiplying the time spent undertaking an activity by it's respective weigh. Scores range from 0 to 360, with higher scores equating to more physical activity.
EQ 5D 5L	6 weeks and 12 weeks	This self-report questionnaire is a measure of health-related quality of life. Scores for each question range from 1 to 5, these scores are converted to an index value ranging from -0.5940 to 1.0000, a higher score indicating a better health state
Self-Efficacy for Exercise Scale	6 weeks and 12 weeks	The Self-Efficacy for Exercise Scale is a self-report scale that measures self-efficacy expectations to continue to exercise in the face of barriers to exercise. It consists of 9 questions each scored from 0 to 10, this gives a total score range of 0 to 90. A higher score indicates higher self-efficacy for exercise.
Exercise Regulations Questionnaire (BREQ-3)	6 weeks and 12 weeks	This self-report questionnaire measures motivation for exercise, it measures forms of intrinsic and extrinsic regulation of exercise behaviour. It consists of 24 questions, each question is scored from 0 to 4, these scores can be summed to give various subscale scores, or all questions can be used by summing scores and multiplying by its subscores weighing to obtain the relative autonomy index (RAI) score. The RAI score can range from -24 to 24. A higher score indicating greater relative autonomy and a lower score indicating more controlled regulation.; higher scores indicates more relative automony, and lower scores a more controlled regulation.
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise	6 weeks and 12 weeks	Participants will be asked to rate their perceived capacity, confidence and motivation to exercise on a scale of 0-10, where 0 is no capacity/confidence/motivation' and 10 is maximum capacity/confidence/motivation

Trial Locations

Locations (1)

Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT; 🇬🇧 Oxford, Oxfordshire, United Kingdom