NCT03643432: AERO

Adherence for Exercise Rehabilitation in Older People Trial

Completed NA Results posted Last updated 28 July 2020

What this trial tests

NA trial testing Exercise adherence intervention in Geriatric in 48 participants. Completed in 31 October 2019.

Timeline

1 September 2018

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	Oxford University Hospitals NHS Trust
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	48
Start date	1 September 2018
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across United Kingdom

Drugs / interventions tested

• Exercise adherence intervention
• Usual Care

Conditions studied

• Geriatric — all drugs for Geriatric →
• Exercise Adherence — all drugs for Exercise Adherence →

Sponsor

Oxford University Hospitals NHS Trust

Who can join

65 and older, any sex, with Geriatric or Exercise Adherence. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Self-reported Adherence Primary · 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'

6 weeks

Group	Value	95% CI
Usual Care	6.77	± 2.86
Exercise Adherence Intervention	7.35	± 3.00

12 weeks

Group	Value	95% CI
Usual Care	6.60	± 3.00
Exercise Adherence Intervention	7.10	± 2.77

Exercise Adherence Rating Scale (EARS) Secondary · 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

Group	Value	95% CI
Usual Care	16.35	± 5.87
Exercise Adherence Intervention	18.25	± 5.82

12 weeks

Group	Value	95% CI
Usual Care	15.64	± 6.60
Exercise Adherence Intervention	17.38	± 6.78

Exercise Diary Secondary · 12 weeks

This diary will have been completed post physiotherapy, recording the number, sets and reps of exercises that the patient has been undertaken.

Group	Value	95% CI
Usual Care	62.57	± 27.47
Exercise Adherence Intervention	77.21	± 18.33

Global Rating of Change Secondary · 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.

6 weeks

Group	Value	95% CI
Usual Care	1	-3 – 3
Exercise Adherence Intervention	1	-3 – 3

12 weeks

Group	Value	95% CI
Usual Care	1	-3 – 3
Exercise Adherence Intervention	1	-3 – 3

Physical Activity Scale for the Elderly (PASE) Secondary · 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.

6 weeks

Group	Value	95% CI
Usual Care	132.96	± 70.75
Exercise Adherence Intervention	131.48	± 70.68

12 weeks

Group	Value	95% CI
Usual Care	132.45	± 70.86
Exercise Adherence Intervention	137.14	± 98.57

EQ 5D 5L Secondary · 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

Group	Value	95% CI
Usual Care	0.632308	± 0.1499250
Exercise Adherence Intervention	0.618553	± 0.2104626

12 weeks

Group	Value	95% CI
Usual Care	0.645892	± 0.1544202
Exercise Adherence Intervention	0.600624	± 0.3110265

Self-Efficacy for Exercise Scale Secondary · 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.

6 weeks

Group	Value	95% CI
Usual Care	61.50	± 22.83
Exercise Adherence Intervention	61.00	± 22.07

12 weeks

Group	Value	95% CI
Usual Care	58.20	± 23.58
Exercise Adherence Intervention	52.53	± 28.16

Exercise Regulations Questionnaire (BREQ-3) Secondary · 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 au

6 weeks

Group	Value	95% CI
Usual Care	9.27	± 8.36
Exercise Adherence Intervention	11.55	± 8.25

12 weeks

Group	Value	95% CI
Usual Care	8.56	± 9.40
Exercise Adherence Intervention	9.71	± 8.31

VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise Secondary · 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

6 weeks Capacity

Group	Value	95% CI
Usual Care	7.85	± 2.05
Exercise Adherence Intervention	7.00	± 2.73

12 weeks Capacity

Group	Value	95% CI
Usual Care	7.44	± 2.60
Exercise Adherence Intervention	7.48	± 2.48

6 weeks Confidence

Group	Value	95% CI
Usual Care	8.00	± 2.26
Exercise Adherence Intervention	7.50	± 2.95

12 weeks confidence

Group	Value	95% CI
Usual Care	7.48	± 2.84
Exercise Adherence Intervention	7.48	± 2.84

6 weeks Motivation

Group	Value	95% CI
Usual Care	8.15	± 2.13
Exercise Adherence Intervention	8.05	± 2.54

12 weeks Motivation

Group	Value	95% CI
Usual Care	8.00	± 2.31
Exercise Adherence Intervention	7.57	± 2.82

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Room J, Dawes H, Boulton M, Barker K. · · 2023 · cited 5× · PMID 36266133 · DOI 10.1016/j.physio.2022.08.006