- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03740412
Study to Reduce Sitting in Older Adults Undergoing Hip or Knee Replacements (INTEREST)
Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
-
Dudley, West Midlands, United Kingdom, DY1 2HQ
- Russells Hall Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Sedentary behaviour reduction (behaviour change techniques)
Intervention group attending visits 1, 2, 3, 4, 5
|
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.
|
No Intervention: Usual care
Will receive usual orthopaedic care, attending visits 1, 4, 5
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Assessed post-study-endpoint (up to month 18)
|
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.
|
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
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
|
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
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
|
Assessed post-study-endpoint (up to month 18)
|
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
|
Assessed post-study-endpoint (up to month 18)
|
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)
|
Assessed post-study-endpoint (up to month 18)
|
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? |
Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
|
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? |
Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
|
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? |
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
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? |
Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
Short Physical Performance Battery (SPPB)
|
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)
|
Assessed via activpal, mean minutes per day
|
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)
|
Assessed via activpal, mean minutes per day
|
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)
|
Assessed via activpal, mean minutes per day
|
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)
|
Assessed via activpal, n/day
|
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)
|
Assessed via activpal, n/day
|
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)
|
Measure of Older Adults' Sedentary Time (MOST)
|
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)
|
EuroQol five dimensions questionnaire (EQ-5D) Assessed for each subscale (1-5 score on each); Mobility, Self-Care, Usual Activities, Pain, and Anxiety
|
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)
|
Scale of overall perceived health on that day: scale 1-100 (100 is best, 0 is worst)
|
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)
|
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.
|
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)
|
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 |
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)
|
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.
|
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)
|
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.
|
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)
|
KGs
|
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)
|
CMs
|
Baseline (visit 1, week 1)
|
Body mass index
Time Frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
|
kg/m2
|
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)
|
Waist to Hip Ratio (WHR) = Gw / Gh
|
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)
|
Short Form Mini Nutritional Assessment (SF-MNA).
Gives a scale from 0-14, where 0 is most severely malnourished.
|
Baseline (visit 1, week 1)
|
Albumin concentration
Time Frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
|
Albumin
|
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)
|
High Density Lipoprotein
|
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)
|
Low density lipoprotein
|
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)
|
Triglycerides
|
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)
|
Vitamin D
|
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)
|
C-Reactive Protein
|
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)
|
Interleukin 6
|
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)
|
Tumor Necrosis Factor Alpha
|
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)
|
Cortisol
|
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)
|
Dehydroepiandrosterone sulfate
|
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)
|
Transferrin
|
Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Justin Aunger, BA, Principal Investigator
Publications and helpful links
General 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.
- Aunger 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.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RG_17-169
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.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States