Study to Reduce Sitting in Older Adults Undergoing Hip or Knee Replacements

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)

Conditions
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Orthopedic Disorder, Arthropathy of Knee, Arthropathy of Hip, Sedentary Lifestyle, Physical Activity, Osteoarthritis

Intervention / Treatment
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* Behavioral: Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sedentary behaviour reduction (behaviour change techniques)<br>Intervention group attending visits 1, 2, 3, 4, 5 | Behavioral: Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls<br>* 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.<br>|
| No Intervention: Usual care<br>Will receive usual orthopaedic care, attending visits 1, 4, 5 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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. | 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 | 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 | 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 | 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) | 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? | 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? | 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? | 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? | 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) | 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 | 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 | 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 | 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 | 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 | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | KGs | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18) | 
| Height | CMs | Baseline (visit 1, week 1) | 
| Body mass index | kg/m2 | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Waist to hip ratio | 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) | 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 | Albumin | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| High Density Lipoprotein concentration | High Density Lipoprotein | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Low density lipoprotein concentration | Low density lipoprotein | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Triglyceride concentration | Triglycerides | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Vitamin D level | Vitamin D | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| C-Reactive Protein concentration | C-Reactive Protein | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Interleukin 6 concentration | Interleukin 6 | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Tumor Necrosis Factor Alpha concentration | Tumor Necrosis Factor Alpha | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Cortisol concentration | Cortisol | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Dehydroepiandrosterone sulfate (DHEAS) concentration | Dehydroepiandrosterone sulfate | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 
| Transferrin concentration | Transferrin | Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sedentary, arthroplasty, osteoarthritis, older adults, elderly, old, elders, sitting, intervention