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Completed

NCT Number: NCT03740412

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

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.

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Key information

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Russells Hall Hospital

Dudley, West Midlands, DY1 2HQ, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls

Behavioral

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.

Primary outcomes

  1. 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)

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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)

  7. 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?

  8. 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?

  9. 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?

  10. 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?

Secondary outcomes

  1. 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)

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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

  9. 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)

  10. 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.

  11. 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

  12. 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.

  13. 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.

  14. 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

  15. Height

    Time frame: Baseline (visit 1, week 1)

    CMs

  16. Body mass index

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    kg/m2

  17. 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

  18. 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.

  19. Albumin concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Albumin

  20. High Density Lipoprotein concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    High Density Lipoprotein

  21. Low density lipoprotein concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Low density lipoprotein

  22. Triglyceride concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Triglycerides

  23. Vitamin D level

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Vitamin D

  24. C-Reactive Protein concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    C-Reactive Protein

  25. Interleukin 6 concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Interleukin 6

  26. Tumor Necrosis Factor Alpha concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Tumor Necrosis Factor Alpha

  27. Cortisol concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Cortisol

  28. Dehydroepiandrosterone sulfate (DHEAS) concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Dehydroepiandrosterone sulfate

  29. Transferrin concentration

    Time frame: Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)

    Transferrin

Sponsors and collaborators

Lead sponsor

University of Birmingham

Other

Collaborators

  • Dudley NHS Foundation Trust
  • European Commission

Registry information

Official study title

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

Acronym: INTEREST

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 14, 2018
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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