Trial Outcomes & Findings for Adherence for Exercise Rehabilitation in Older People Trial (NCT NCT03643432)

NCT ID: NCT03643432

Last Updated: 2020-07-28

Results Overview

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'

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

48 participants

Primary outcome timeframe

12 weeks

Results posted on

2020-07-28

Participant Flow

Participant milestones

Participant milestones
Measure
Usual Care
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Overall Study
STARTED
27
21
Overall Study
COMPLETED
26
21
Overall Study
NOT COMPLETED
1
0

Reasons for withdrawal

Reasons for withdrawal
Measure
Usual Care
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Overall Study
Lost to Follow-up
1
0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Total
n=47 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=26 Participants
0 Participants
n=21 Participants
0 Participants
n=47 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=26 Participants
0 Participants
n=21 Participants
0 Participants
n=47 Participants
Age, Categorical
>=65 years
26 Participants
n=26 Participants
21 Participants
n=21 Participants
47 Participants
n=47 Participants
Age, Continuous
74.58 years
STANDARD_DEVIATION 7.05 • n=26 Participants
74.10 years
STANDARD_DEVIATION 6.20 • n=21 Participants
74.36 years
STANDARD_DEVIATION 6.62 • n=47 Participants
Sex: Female, Male
Female
17 Participants
n=26 Participants
13 Participants
n=21 Participants
30 Participants
n=47 Participants
Sex: Female, Male
Male
9 Participants
n=26 Participants
8 Participants
n=21 Participants
17 Participants
n=47 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.
Region of Enrollment
United Kingdom
26 participants
n=26 Participants
21 participants
n=21 Participants
47 participants
n=47 Participants
Tilburg Frailty Indicator
5.04 units on a scale
STANDARD_DEVIATION 3.34 • n=26 Participants
4.86 units on a scale
STANDARD_DEVIATION 3.41 • n=21 Participants
4.96 units on a scale
STANDARD_DEVIATION 2.84 • n=47 Participants
Physical Activity Scale for the Elderly (PASE)
137.61 units on a scale
STANDARD_DEVIATION 82.67 • n=26 Participants
112.50 units on a scale
STANDARD_DEVIATION 70.08 • n=21 Participants
126.38 units on a scale
STANDARD_DEVIATION 82.67 • n=47 Participants
Self-efficacy for exercise scale
64.69 units on a scale
STANDARD_DEVIATION 21.52 • n=26 Participants
59.14 units on a scale
STANDARD_DEVIATION 19.43 • n=21 Participants
62.21 units on a scale
STANDARD_DEVIATION 20.58 • n=47 Participants
Self-rated capacity to exercise
6.77 units on a scale
STANDARD_DEVIATION 2.47 • n=26 Participants
6.48 units on a scale
STANDARD_DEVIATION 2.66 • n=21 Participants
6.64 units on a scale
STANDARD_DEVIATION 2.53 • n=47 Participants
Self-rated confidence to exercise
7.35 units on a scale
STANDARD_DEVIATION 2.56 • n=26 Participants
6.48 units on a scale
STANDARD_DEVIATION 2.58 • n=21 Participants
6.96 units on a scale
STANDARD_DEVIATION 2.58 • n=47 Participants
Self-rated motivation to exercise
7.85 units on a scale
STANDARD_DEVIATION 2.54 • n=26 Participants
7.29 units on a scale
STANDARD_DEVIATION 2.43 • n=21 Participants
7.60 units on a scale
STANDARD_DEVIATION 2.48 • n=47 Participants

PRIMARY outcome

Timeframe: 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'

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Self-reported Adherence
6 weeks
6.77 score on a scale
Standard Deviation 2.86
7.35 score on a scale
Standard Deviation 3.00
Self-reported Adherence
12 weeks
6.60 score on a scale
Standard Deviation 3.00
7.10 score on a scale
Standard Deviation 2.77

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Exercise Adherence Rating Scale (EARS)
6 weeks
16.35 score on a scale
Standard Deviation 5.87
18.25 score on a scale
Standard Deviation 5.82
Exercise Adherence Rating Scale (EARS)
12 weeks
15.64 score on a scale
Standard Deviation 6.60
17.38 score on a scale
Standard Deviation 6.78

SECONDARY outcome

Timeframe: 12 weeks

Population: Some participants lost their diaries and did not return them at follow up, therefore 21 in usual care were analysis and 16 in the intervention arm were analysed.

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

Outcome measures

Outcome measures
Measure
Usual Care
n=21 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=16 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Exercise Diary
62.57 percentage of completed exercise
Standard Deviation 27.47
77.21 percentage of completed exercise
Standard Deviation 18.33

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Global Rating of Change
6 weeks
1 units on a scale
Interval -3.0 to 3.0
1 units on a scale
Interval -3.0 to 3.0
Global Rating of Change
12 weeks
1 units on a scale
Interval -3.0 to 3.0
1 units on a scale
Interval -3.0 to 3.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Physical Activity Scale for the Elderly (PASE)
6 weeks
132.96 score on a scale
Standard Deviation 70.75
131.48 score on a scale
Standard Deviation 70.68
Physical Activity Scale for the Elderly (PASE)
12 weeks
132.45 score on a scale
Standard Deviation 70.86
137.14 score on a scale
Standard Deviation 98.57

SECONDARY outcome

Timeframe: 6 weeks and 12 weeks

Population: Numbers analysed different at 6 and 12 weeks due to sections of questionnaires not completed by 2 participants

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

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
EQ 5D 5L
6 weeks
0.632308 units on a scale
Standard Deviation 0.1499250
0.618553 units on a scale
Standard Deviation 0.2104626
EQ 5D 5L
12 weeks
0.645892 units on a scale
Standard Deviation 0.1544202
0.600624 units on a scale
Standard Deviation 0.3110265

SECONDARY outcome

Timeframe: 6 weeks and 12 weeks

Population: At 12 weeks, 2 questionnaires had SEE left blank

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.

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Self-Efficacy for Exercise Scale
6 weeks
61.50 score on a scale
Standard Deviation 22.83
61.00 score on a scale
Standard Deviation 22.07
Self-Efficacy for Exercise Scale
12 weeks
58.20 score on a scale
Standard Deviation 23.58
52.53 score on a scale
Standard Deviation 28.16

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
Exercise Regulations Questionnaire (BREQ-3)
6 weeks
9.27 units on a scale
Standard Deviation 8.36
11.55 units on a scale
Standard Deviation 8.25
Exercise Regulations Questionnaire (BREQ-3)
12 weeks
8.56 units on a scale
Standard Deviation 9.40
9.71 units on a scale
Standard Deviation 8.31

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure
Usual Care
n=26 Participants
The usual care arm will consist of routine physiotherapy treatment, without the intervention. 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
Exercise Adherence Intervention
n=21 Participants
The intervention arm will consist of a brief behavioural assessment and recommended adherence strategies based on the outcome of the assessment. 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.
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
6 weeks Capacity
7.85 score on a scale
Standard Deviation 2.05
7.00 score on a scale
Standard Deviation 2.73
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
12 weeks Capacity
7.44 score on a scale
Standard Deviation 2.60
7.48 score on a scale
Standard Deviation 2.48
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
6 weeks Confidence
8.00 score on a scale
Standard Deviation 2.26
7.50 score on a scale
Standard Deviation 2.95
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
12 weeks confidence
7.48 score on a scale
Standard Deviation 2.84
7.48 score on a scale
Standard Deviation 2.84
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
6 weeks Motivation
8.15 score on a scale
Standard Deviation 2.13
8.05 score on a scale
Standard Deviation 2.54
VAS Self-rated Capacity to Exercise, Confidence to Exercise and Motivation to Exercise
12 weeks Motivation
8.00 score on a scale
Standard Deviation 2.31
7.57 score on a scale
Standard Deviation 2.82

Adverse Events

Usual Care

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Exercise Adherence Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jon Room

Oxford University Hospitals NHS FT

Phone: 01865737526

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place