- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643432
Adherence for Exercise Rehabilitation in Older People Trial (AERO)
Can a Brief Behavioural Assessment Improve Exercise Adherence in Older People With Musculoskeletal Conditions: A Feasibility Randomised Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Oxfordshire
-
Oxford, Oxfordshire, United Kingdom, OX3 7HE
- Nuffield Orthopaedic Centre, Oxford University Hospitals NHS FT
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Usual care
The usual care arm will consist of routine physiotherapy treatment, without the intervention.
|
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
|
EXPERIMENTAL: Exercise adherence intervention
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported Adherence
Time Frame: 12 weeks
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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'
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12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exercise Adherence Rating Scale (EARS)
Time Frame: 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.
|
6 weeks and 12 weeks
|
Exercise Diary
Time Frame: 12 weeks
|
This diary will have been completed post physiotherapy, recording the number, sets and reps of exercises that the patient has been undertaken.
|
12 weeks
|
Global Rating of Change
Time Frame: 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.
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6 weeks and 12 weeks
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Physical Activity Scale for the Elderly (PASE)
Time Frame: 6 weeks and 12 weeks
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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.
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6 weeks and 12 weeks
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EQ 5D 5L
Time Frame: 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
|
6 weeks and 12 weeks
|
Self-Efficacy for Exercise Scale
Time Frame: 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.
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6 weeks and 12 weeks
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Exercise Regulations Questionnaire (BREQ-3)
Time Frame: 6 weeks and 12 weeks
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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. |
6 weeks and 12 weeks
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VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
Time Frame: 6 weeks and 12 weeks
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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
|
6 weeks and 12 weeks
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Jonathan F Room, MRes, Oxford University Hospitals NHS Trust
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 13594
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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