Orthopedic DisorderINTERESTNCT03740412
Study to Reduce Sitting in Older Adults Undergoing Hip or Knee Replacements
A study testing Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls in people with Orthopedic Disorder and Arthropathy of Knee, run by University of Birmingham at 1 site in United Kingdom.
Trial summary
The aim of this study is to investigate the feasibility of an intervention to reduce sedentary behaviour in older adults waiting for hip and knee replacements. The study will be a randomised controlled trial design, including 2:1 randomisation into an intervention and usual care group respectively. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Orthopedic Disorder, Arthropathy of Knee, Arthropathy of Hip
- What is being tested?
- Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Jan 2018to 15 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged ≥60 years.
- Listed for elective hip or knee surgery.
- Capable of providing informed consent.
- Regular access to a phone at pre-specified times.
- Able to speak English.
Who cannot join
- Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments as indicated by the research nurse prior to recruitment.
- Significant co-morbid disease that would pose a safety threat, affect blood measures significantly, or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, or an active cancer other than skin cancer.
- Working more than 2 days per week.
- Unwillingness or inability to comply with the intervention.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Russells Hall Hospital
Dudley, West Midlands, DY1 2HQ
About this study
Official title: Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)
The aim of this study is to investigate the feasibility of an intervention to reduce sedentary behaviour in older adults waiting for hip and knee replacements. The study will be a randomised controlled trial design, including 2:1 randomisation into an intervention and usual care group respectively. A target of n=45 patients ≥60 years will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10 weeks before surgery, assisted by research nurses. The variable-length intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely motivational interviewing, individualised feedback on sedentariness, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1 week pre-surgery, and 6 weeks post-surgery. The primary outcome will be the feasibility of the trial, assessed quantitatively using study statistics, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety via questionnaires given to participants. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement daily activity and sedentariness. The study will last up to 18 weeks per participant.
Read the detailed description
The aim of this study is to investigate the feasibility of an intervention to reduce sedentary behaviour in n=45 older adults undergoing orthopaedic surgery, at Russells Hall Hospital, Dudley, Birmingham, UK. Recruitment will be via screening of surgery lists followed by direct contact with potentially eligible participants. The intervention is designed utilising Self Determination Theory. It is designed to have multiple components: incorporating individualised feedback on sitting time, education about sedentary behaviour, individualised goal-setting and environmental modification according to each participant's own behavioural patterns and capabilities, motivational interviewing, and biweekly phone calls.
Due to variation in surgery times, the intervention will be variable but can last up to 18 weeks. Each participant will undertake 3-5 visits depending on whether they are in the control group (n=3 visits) or intervention group (n=5 visits). The intervention group will undergo baseline assessments, two intervention meetings, pre-surgical assessments, and a 6-week post-surgical follow up. These visits will occur in different weeks for each participant due to the variability of surgery, however visit 2 will occur 1 week after visit 1. Visit 3 will occur shortly thereafter but may also be combined with visit 2. Visit 4 will occur the week prior to surgery, which is intended to be 6-10 weeks after baseline. Visit 5 occurs 6 weeks post-surgery, which should be 12-18 weeks post-baseline. The primary outcome measure will be feasibility, assessed quantitatively with study statistics. Secondary outcome will be mixed-methods assessment of feasibility via bespoke participant questionnaires. Exploratory outcomes will cover a number of mental and physical health variables, including blood measures to assess cardiometabolic biomarkers, as well as physical function using the short physical performance battery (SPPB). Surgical recovery will be assessed using the Oxford Hip/Knee score and the SPPB. The results of this feasibility study will serve to aid the design of a definitive trial of an intervention to reduce sedentary behaviour in this population.
- Conditions
- Orthopedic Disorder, Arthropathy of Knee, Arthropathy of Hip, Sedentary Lifestyle, Physical Activity, Osteoarthritis
- Being tested
- Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls
- Keywords
- sedentary, arthroplasty, osteoarthritis, older adults, elderly, old, elders, sitting, intervention
- Medical subject headings
- Musculoskeletal Diseases, Sedentary Behavior, Motor Activity, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone callsBehavioural
The intervention has multiple components in order to reduce sedentary behaviour, namely: incorporating individualised feedback on sitting time, education about sedentary behaviour, individualised goal-setting and environmental modification according to each participant's own behavioural patterns and capabilities, motivational interviewing, and biweekly phone calls.
| Study group | Role | What they receive |
|---|---|---|
| Sedentary behaviour reduction (behaviour change techniques) | Experimental | Intervention group attending visits 1, 2, 3, 4, 5 Receives: Behavioral: Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls |
| Usual care | No intervention | Will receive usual orthopaedic care, attending visits 1, 4, 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth)
Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth)
Measured: Assessed post-study-endpoint (up to month 18)
Intervention adherence to goals
Self-recording by participants of goal achievement on a scale of 1-5, recorded each week for the first 6 weeks of the intervention in their goal-setting booklet.
Measured: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention
Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention
Measured: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention
Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention
Measured: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is cancelled or delayed for too long
Percentage of participants whose surgery is delayed beyond 3 weeks post-intervention
Measured: Assessed post-study-endpoint (up to month 18)
Retention rates (% of participants randomised who provide data at follow-up)
Assessed by the number of participants who attend the follow-up visit (visit 5, 6 weeks post-surgery)
Measured: Assessed post-study-endpoint (up to month 18)
Acceptability of intervention for participants
Assessed by custom-made feasibility questionnaire which uses a number of closed and open questions. Closed questions include (Likert 1-5 scale):
How easy was it to achieve your goals physically? How easy was it to achieve your goals mentally? Have you found taking part in the study burdensome?
Measured: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Practicality of intervention for participants
Assessed by custom-made feasibility questionnaires, using both closed and open questions. Closed questions include (1-5 Likert scale):
Could you have changed your goals to make them more achievable? Which part(s) of the intervention did you find most difficult?
Measured: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Participant satisfaction with the study
Whether patients are satisfied, as assessed by feasibility questionnaires given at visit 4 (week prior to surgery) and visit 5 (week post-surgery). This included open and closed questions. Closed questions include (Likert scale 1-5):
Which part(s) of the intervention did you find most enjoyable? How would you rate your overall satisfaction with the study? How likely would you be to suggest taking part in such a study to friends or family? How likely are you to continue working towards your goals in the future?
Measured: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Patient perception of the safety of the study as assessed by questionnaire
Any change in patient safety as assessed by custom-made feasibility questionnaires. This includes closed and open questions. Closed questions include (Likert 1-3 scale):
Do you feel that taking part in the study has exposed you to more pain? Do you feel that taking part in the study has exposed you to risk of physical harm?
Measured: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Secondary outcomes (29)
Short Physical Performance Battery (SPPB)
Short Physical Performance Battery (SPPB)
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Sitting time
Assessed via activpal, mean minutes per day
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Standing time
Assessed via activpal, mean minutes per day
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Stepping time
Assessed via activpal, mean minutes per day
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Sit-to-stand transitions
Assessed via activpal, n/day
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Quantity of sedentary bouts >30 minutes
Assessed via activpal, n/day
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Measure of Older Adults' Sedentary Time (MOST)
Measure of Older Adults' Sedentary Time (MOST)
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
EuroQol five dimensions questionnaire (EQ-5D)
EuroQol five dimensions questionnaire (EQ-5D) Assessed for each subscale (1-5 score on each); Mobility, Self-Care, Usual Activities, Pain, and Anxiety
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
EQ-VAS
Scale of overall perceived health on that day: scale 1-100 (100 is best, 0 is worst)
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Oxford Hip/Knee Score
Oxford Hip/Knee Score. Reported as a scale from 0-48, where 0 is the most severe hip/knee osteoarthritis, and 48 is no indication of hip/knee osteoarthritis.
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Basic Psychological Needs Scale
Three subscales: autonomy, relatedness, and competence. R equals reverse scoring. Max score for each is 49. Total score is not computed.
Autonomy:
1, 4(R), 8, 11(R), 14, 17, 20(R)
Competence:
3(R), 5, 10, 13, 15(R), 19(R)
Relatedness:
2, 6, 7(R), 9, 12, 16(R), 18(R), 21
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
International Physical Activity Questionnaire (IPAQ) Short Form
The International Physical Activity Questionnaire (IPAQ) Short Form asks the amount of hours spent doing vigorous, moderate, and walking activities per day, and for how many days. It also asks for the average perceived sitting time per day.This gives a score for self-reported Vigorous Physical Activity, Moderate Physical Activity, Walking, and Sitting time.
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Katz Activites of Daily Living
Each item assess independence, in several domains, namely has a maximal overall score of 6 indicating maximal independence. The items are Bathing, Dressing, Toileting, Continence, Transferring (from bed to chair) and Feeding.
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Body weight
KGs
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Height
CMs
Measured: Baseline (visit 1, week 1)
Body mass index
kg/m2
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Waist to hip ratio
Waist to Hip Ratio (WHR) = Gw / Gh
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Short Form Mini Nutritional Assessment (SF-MNA)
Short Form Mini Nutritional Assessment (SF-MNA). Gives a scale from 0-14, where 0 is most severely malnourished.
Measured: Baseline (visit 1, week 1)
Albumin concentration
Albumin
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
High Density Lipoprotein concentration
High Density Lipoprotein
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Low density lipoprotein concentration
Low density lipoprotein
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Triglyceride concentration
Triglycerides
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Vitamin D level
Vitamin D
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
C-Reactive Protein concentration
C-Reactive Protein
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Interleukin 6 concentration
Interleukin 6
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Tumor Necrosis Factor Alpha concentration
Tumor Necrosis Factor Alpha
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Cortisol concentration
Cortisol
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Dehydroepiandrosterone sulfate (DHEAS) concentration
Dehydroepiandrosterone sulfate
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Transferrin concentration
Transferrin
Measured: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2018
- Study start29 Jan 2018
- Primary completion15 Apr 2019
- Study completion15 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Orthopedic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- European Commission, Dudley NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Justin Aunger, BA, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03740412
- Sponsor's protocol ID
- RG_17-169
- Acronym
- INTEREST
- Status last verified
- Jul 2019
- First submitted
- 4 Dec 2017
- Last updated
- 5 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Aunger JA, Greaves CJ, Davis ET, Asamane EA, Whittaker AC, Greig CA. A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study. Aging Clin Exp Res. 2020 Dec;32(12):2565-2585. doi: 10.1007/s40520-020-01475-6. Epub 2020 Jan 23.
PubMed 31975288Aunger JA, Greaves CJ, Davis ET, Greig CA. A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study. Pilot Feasibility Stud. 2019 Apr 6;5:54. doi: 10.1186/s40814-019-0437-2. eCollection 2019.
PubMed 30997142
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)
- ClinicalTrials.gov ID
- NCT03740412
- Acronym / sponsor ID
- INTEREST / RG_17-169
- Conditions
- Orthopedic Disorder, Arthropathy of Knee, Arthropathy of Hip, Sedentary Lifestyle, Physical Activity, Osteoarthritis
- Keywords
- sedentary, arthroplasty, osteoarthritis, older adults, elderly, old, elders, sitting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of BirminghamUniversity, hospital or other
- Collaborators
- European Commission, Dudley NHS Foundation Trust
- Study start
- 29 Jan 2018 (actual)
- Primary completion
- 15 Apr 2019 (actual)
- Study completion
- 15 Apr 2019 (actual)
- First posted
- 14 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to investigate the feasibility of an intervention to reduce sedentary behaviour in older adults waiting for hip and knee replacements. The study will be a randomised controlled trial design, including 2:1 randomisation into an intervention and usual care group respectively. A target of n=45 patients ≥60 years will be recruited from Russells Hall Hospital, Dudley, UK, approximately 8-10 weeks before surgery, assisted by research nurses. The variable-length intervention, informed by Self-Determination Theory (SDT), will be composed of multiple behaviour change techniques, namely motivational interviewing, individualised feedback on sedentariness, goal-setting, environmental modification, self-monitoring, and social support. Assessments will occur at baseline, 1 week pre-surgery, and 6 weeks post-surgery. The primary outcome will be the feasibility of the trial, assessed quantitatively using study statistics, and with mixed-methods assessment of acceptability, practicality, adaption, satisfaction, and safety via questionnaires given to participants. Exploratory outcomes will include physical function, cardiometabolic biomarkers, measurement of SDT constructs, and both objective and subjective measurement daily activity and sedentariness. The study will last up to 18 weeks per participant.
Detailed description
The aim of this study is to investigate the feasibility of an intervention to reduce sedentary behaviour in n=45 older adults undergoing orthopaedic surgery, at Russells Hall Hospital, Dudley, Birmingham, UK. Recruitment will be via screening of surgery lists followed by direct contact with potentially eligible participants. The intervention is designed utilising Self Determination Theory. It is designed to have multiple components: incorporating individualised feedback on sitting time, education about sedentary behaviour, individualised goal-setting and environmental modification according to each participant's own behavioural patterns and capabilities, motivational interviewing, and biweekly phone calls.
Due to variation in surgery times, the intervention will be variable but can last up to 18 weeks. Each participant will undertake 3-5 visits depending on whether they are in the control group (n=3 visits) or intervention group (n=5 visits). The intervention group will undergo baseline assessments, two intervention meetings, pre-surgical assessments, and a 6-week post-surgical follow up. These visits will occur in different weeks for each participant due to the variability of surgery, however visit 2 will occur 1 week after visit 1. Visit 3 will occur shortly thereafter but may also be combined with visit 2. Visit 4 will occur the week prior to surgery, which is intended to be 6-10 weeks after baseline. Visit 5 occurs 6 weeks post-surgery, which should be 12-18 weeks post-baseline. The primary outcome measure will be feasibility, assessed quantitatively with study statistics. Secondary outcome will be mixed-methods assessment of feasibility via bespoke participant questionnaires. Exploratory outcomes will cover a number of mental and physical health variables, including blood measures to assess cardiometabolic biomarkers, as well as physical function using the short physical performance battery (SPPB). Surgical recovery will be assessed using the Oxford Hip/Knee score and the SPPB. The results of this feasibility study will serve to aid the design of a definitive trial of an intervention to reduce sedentary behaviour in this population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary behaviour reduction (behaviour change techniques) | Experimental | Behavioral: Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone callsIntervention group attending visits 1, 2, 3, 4, 5 |
| Usual care | No intervention | –Will receive usual orthopaedic care, attending visits 1, 4, 5 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men and women aged ≥60 years.
- Listed for elective hip or knee surgery.
- Capable of providing informed consent.
- Regular access to a phone at pre-specified times.
- Able to speak English.
Key exclusion criteria (4 listed)
- Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments as indicated by the research nurse prior to recruitment.
- Significant co-morbid disease that would pose a safety threat, affect blood measures significantly, or impair ability to participate such as coronary artery disease, severe hypertension, peripheral vascular disease, stroke, congestive heart failure, chronic obstructive pulmonary disease, insulin-dependent diabetes, psychiatric disease, renal disease, liver disease, or an active cancer other than skin cancer.
- Working more than 2 days per week.
- Unwillingness or inability to comply with the intervention.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone callsThe intervention has multiple components in order to reduce sedentary behaviour, namely: incorporating individualised feedback on sitting time, education about sedentary behaviour, individualised goal-setting and environmental modification according to each participant's own behavioural patterns and capabilities, motivational interviewing, and biweekly phone calls. | Behavioural | Sedentary behaviour reduction (behaviour change techniques) |
Primary outcome
Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth)
Time frame: Assessed post-study-endpoint (up to month 18)
Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth)
Intervention adherence to goals
Time frame: Assessed post-study-endpoint (up to month 18)
Self-recording by participants of goal achievement on a scale of 1-5, recorded each week for the first 6 weeks of the intervention in their goal-setting booklet.
Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention
Time frame: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention
Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention
Time frame: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention
Percentage of participants whose surgery is cancelled or delayed for too long
Time frame: Assessed post-study-endpoint (up to month 18)
Percentage of participants whose surgery is delayed beyond 3 weeks post-intervention
Retention rates (% of participants randomised who provide data at follow-up)
Time frame: Assessed post-study-endpoint (up to month 18)
Assessed by the number of participants who attend the follow-up visit (visit 5, 6 weeks post-surgery)
Acceptability of intervention for participants
Time frame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Assessed by custom-made feasibility questionnaire which uses a number of closed and open questions. Closed questions include (Likert 1-5 scale): How easy was it to achieve your goals physically? How easy was it to achieve your goals mentally? Have you found taking part in the study burdensome?
Practicality of intervention for participants
Time frame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Assessed by custom-made feasibility questionnaires, using both closed and open questions. Closed questions include (1-5 Likert scale): Could you have changed your goals to make them more achievable? Which part(s) of the intervention did you find most difficult?
Participant satisfaction with the study
Time frame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Whether patients are satisfied, as assessed by feasibility questionnaires given at visit 4 (week prior to surgery) and visit 5 (week post-surgery). This included open and closed questions. Closed questions include (Likert scale 1-5): Which part(s) of the intervention did you find most enjoyable? How would you rate your overall satisfaction with the study? How likely would you be to suggest taking part in such a study to friends or family? How likely are you to continue working towards your goals in the future?
Patient perception of the safety of the study as assessed by questionnaire
Time frame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Any change in patient safety as assessed by custom-made feasibility questionnaires. This includes closed and open questions. Closed questions include (Likert 1-3 scale): Do you feel that taking part in the study has exposed you to more pain? Do you feel that taking part in the study has exposed you to risk of physical harm?
29 secondary outcomes
Short Physical Performance Battery (SPPB)
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Sitting time
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Standing time
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Stepping time
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Sit-to-stand transitions
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Quantity of sedentary bouts >30 minutes
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Measure of Older Adults' Sedentary Time (MOST)
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
EuroQol five dimensions questionnaire (EQ-5D)
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
EQ-VAS
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Oxford Hip/Knee Score
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Basic Psychological Needs Scale
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
International Physical Activity Questionnaire (IPAQ) Short Form
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Katz Activites of Daily Living
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Body weight
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Height
Time frame: Baseline (visit 1, week 1)
Body mass index
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Waist to hip ratio
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Short Form Mini Nutritional Assessment (SF-MNA)
Time frame: Baseline (visit 1, week 1)
Albumin concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
High Density Lipoprotein concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Low density lipoprotein concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Triglyceride concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Vitamin D level
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
C-Reactive Protein concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Interleukin 6 concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Tumor Necrosis Factor Alpha concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Cortisol concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Dehydroepiandrosterone sulfate (DHEAS) concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Transferrin concentration
Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
- Derived from this study: PubMed 31975288Aunger JA, Greaves CJ, Davis ET, Asamane EA, Whittaker AC, Greig CA. A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): results of a randomised-controlled feasibility study. Aging Clin Exp Res. 2020 Dec;32(12):2565-2585. doi: 10.1007/s40520-020-01475-6. Epub 2020 Jan 23.
- Derived from this study: PubMed 30997142Aunger JA, Greaves CJ, Davis ET, Greig CA. A novel behavioural INTErvention to REduce Sitting Time in older adults undergoing orthopaedic surgery (INTEREST): protocol for a randomised controlled feasibility study. Pilot Feasibility Stud. 2019 Apr 6;5:54. doi: 10.1186/s40814-019-0437-2. eCollection 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin Aunger, BA principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls in people with Orthopedic Disorder and Arthropathy of Knee, run by University of Birmingham at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth) (time frame: Assessed post-study-endpoint (up to month 18)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03740412, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2019.