Clinical trial NCT03740412: Study to Reduce Sitting in Older Adults Undergoing Hip or Knee Replacements
Official title: Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Disorder
Arthropathy of Knee
Arthropathy of Hip
Sedentary Lifestyle
Physical Activity
Osteoarthritis
Keywords: sedentary
arthroplasty
osteoarthritis
older adults
elderly
old
elders
sitting
intervention
Lead sponsor: University of Birmingham
Sponsor class: OTHER
Collaborators: name: European Commission
name: Dudley NHS Foundation Trust
First posted: 2018-11-14
Enrollment: 35
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Men and women aged ≥60 years.
2. Listed for elective hip or knee surgery.
3. Capable of providing informed consent.
4. Regular access to a phone at pre-specified times.
5. Able to speak English.

Exclusion Criteria:

1. Neuromuscular impairments that preclude participating in physical activity, visual, hearing, or moderate/ severe cognitive impairments as indicated by the research nurse prior to recruitment.
2. 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.
3. Working more than 2 days per week.
4. Unwillingness or inability to comply with the intervention.

Primary outcomes:
measure: Study uptake rates (as % of those approached who are randomised, recruitment rates (N/mth)
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Intervention adherence to goals
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Percentage of participants whose surgery is scheduled up to 2 weeks prior to the end of the intervention
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Percentage of participants whose surgery is scheduled up to three weeks after the end of the intervention
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Percentage of participants whose surgery is cancelled or delayed for too long
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Retention rates (% of participants randomised who provide data at follow-up)
timeFrame: Assessed post-study-endpoint (up to month 18)
measure: Acceptability of intervention for participants
timeFrame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Practicality of intervention for participants
timeFrame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Participant satisfaction with the study
timeFrame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Patient perception of the safety of the study as assessed by questionnaire
timeFrame: Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Secondary outcomes:
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Sitting time
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Standing time
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Stepping time
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Sit-to-stand transitions
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Quantity of sedentary bouts >30 minutes
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Measure of Older Adults' Sedentary Time (MOST)
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: EuroQol five dimensions questionnaire (EQ-5D)
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: EQ-VAS
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Oxford Hip/Knee Score
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Basic Psychological Needs Scale
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: International Physical Activity Questionnaire (IPAQ) Short Form
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Katz Activites of Daily Living
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Body weight
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
measure: Height
timeFrame: Baseline (visit 1, week 1)
measure: Body mass index
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Waist to hip ratio
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Short Form Mini Nutritional Assessment (SF-MNA)
timeFrame: Baseline (visit 1, week 1)
measure: Albumin concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: High Density Lipoprotein concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Low density lipoprotein concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Triglyceride concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Vitamin D level
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: C-Reactive Protein concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Interleukin 6 concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Tumor Necrosis Factor Alpha concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Cortisol concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Dehydroepiandrosterone sulfate (DHEAS) concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
measure: Transferrin concentration
timeFrame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Other outcomes:
Locations:
city: Dudley
country: United Kingdom
facility: Russells Hall Hospital
state: West Midlands
Study officials:
affiliation: Principal Investigator
name: Justin Aunger, BA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.