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

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ClinicalTrials.gov Identifier: NCT03740412
Recruitment Status : Completed
First Posted : November 14, 2018
Last Update Posted : July 3, 2019
Sponsor:
Collaborators:
European Commission
Dudley NHS Foundation Trust
Information provided by (Responsible Party):
University of Birmingham

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.

Condition or disease Intervention/treatment Phase
Orthopedic Disorder Arthropathy of Knee Arthropathy of Hip Sedentary Lifestyle Physical Activity Osteoarthritis Behavioral: Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Intervention to Reduce Sedentary Time in Older Adults Undergoing Orthopaedic Surgery: a Feasibility Study (INTEREST)
Actual Study Start Date : January 29, 2018
Actual Primary Completion Date : April 15, 2019
Actual Study Completion Date : April 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sedentary behaviour reduction (behaviour change techniques)
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
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



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740412


Locations
Layout table for location information
United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom, DY1 2HQ
Sponsors and Collaborators
University of Birmingham
European Commission
Dudley NHS Foundation Trust
Investigators
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Principal Investigator: Justin Aunger, BA Principal Investigator

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Birmingham
ClinicalTrials.gov Identifier: NCT03740412     History of Changes
Other Study ID Numbers: RG_17-169
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Birmingham:
sedentary
arthroplasty
osteoarthritis
older adults
elderly
old
elders
sitting
intervention

Additional relevant MeSH terms:
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Osteoarthritis
Joint Diseases
Musculoskeletal Diseases
Arthritis
Rheumatic Diseases