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

Osteoarthritis Clinical Trial

— INTEREST  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740412
• Other study ID #: RG_17-169
• Status: Completed
• Phase: N/A
• Start date: January 29, 2018
• Est. completion date: April 15, 2019

Study information

• Verified date: July 2019
• Source: University of Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Arthropathy of Hip
• Arthropathy of Knee
• Joint Diseases
• Musculoskeletal Diseases
• Orthopedic Disorder
• Osteoarthritis
• Physical Activity
• Sedentary Lifestyle

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Russells Hall Hospital	Dudley	West Midlands

Sponsors (3)

Lead Sponsor	Collaborator
University of Birmingham	Dudley NHS Foundation Trust, European Commission

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Body weight	KGs	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10), post-surgery (visit 5, up to week 18)
Secondary	Height	CMs	Baseline (visit 1, week 1)
Secondary	Body mass index	kg/m2	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Waist to hip ratio	Waist to Hip Ratio (WHR) = Gw / Gh	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	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)
Secondary	Albumin concentration	Albumin	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	High Density Lipoprotein concentration	High Density Lipoprotein	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Low density lipoprotein concentration	Low density lipoprotein	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Triglyceride concentration	Triglycerides	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Vitamin D level	Vitamin D	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	C-Reactive Protein concentration	C-Reactive Protein	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Interleukin 6 concentration	Interleukin 6	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Tumor Necrosis Factor Alpha concentration	Tumor Necrosis Factor Alpha	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Cortisol concentration	Cortisol	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Dehydroepiandrosterone sulfate (DHEAS) concentration	Dehydroepiandrosterone sulfate	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)
Secondary	Transferrin concentration	Transferrin	Baseline (visit 1, week 1), Pre-surgery (visit 4, up to week 10)