Health Coaching for Patients Waiting for Total Hip or Knee Replacements

Not Applicable

• Conditions: Arthritis Knee; Arthritis of Hip

• Registration Number: NCT06596031
• Lead Sponsor: Sheffield Hallam University

Brief Summary

This pilot study aims to evaluate the feasibility of collecting objective data on physical performance to measure the impact of health coaching in addition to a digital resource (Active Wait) and enable sample size calculation for a larger scale RCT.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Study Start: 2025-02-27
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-28
• Last Update Posted: 2025-06-03
• Primary Completion: 2025-08
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• patients scheduled on the waitlist for a total joint replacement surgery for hip/knee, ie clinically and radiographically diagnosed, symptomatic knee/hip osteoarthritis deemed suitable for surgical intervention;
• have access to the internet and the ability to navigate web-based programs;
• able and willing to travel to Advanced Wellbeing Research Centre for baseline and follow-up assessments;
• able to comprehend the requirements and purpose of the study and give informed consent

Exclusion Criteria

• other musculoskeletal lower limb or back conditions requiring assessment or treatment by a health professional in the last 6 months;
• neurological impairment or condition affecting lower limb function; conditions listed as both absolute and relative contraindications for physical activities by the American College of Sports Medicine (ACSM), such as unstable angina, uncontrolled diabetes;
• systemic inflammatory disease (e.g. rheumatoid arthritis);
• previous total joint replacement surgery (hip or knee)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Global rating of change	12 weeks	Bowens Framework - acceptability (Perceived benefits) 7-point likert scale global rating of change (GROC) with -3 being worse, 0 being no change and 3 being better
Perceived Satisfaction	12 weeks	Bowens Framework - acceptability (Perceived satisfaction). How satisfied were you with the overall information, level of support, and ease of use of the program? Measured on a numeric rating scale, where 0 means not satisfied, 10 means significant satisfaction.
Rate of retention	12 weeks	Bowens Framework - acceptability, percentage of participants progressing from baseline, to midpoint and post-intervention assessments
Adverse events	12 weeks	Bowens Framework- practicality, measured by number, type and severity of adverse events
Rate of service utilisation	12 weeks	Bowens Framework - implementation, measured by the number of attended sessions (health coaching) number of days during the week using the active wait website
Rates of recruitment	12 weeks	Bowens Framework - demand, measured by n number of recruitment per week.
Drop out rate	12 weeks	Bowens Framework - acceptability, percentage of people discontinuing in both groups

Secondary Outcome Measures

Name	Time	Method
Demographics	12 weeks	height and weight aggregated to arrive at one reported value BMI, in units kg/m\^2
Arthritis Self-Efficacy Scale (ASES-8)	12 weeks	Self efficacy questionnaire. Contains 8 items, each measured on a scale from 1-10. Higher score indicates greater self-efficacy.
International physical activity questionnaire-short form (IPAQ-SF)	12 weeks	Physical activity level is measured in three categories, walking, moderate-intensity activities, vigorous-intensity activities, in addition to sitting. Their score is then expressed as MET-min per week.
EuroQoL Group's 5-dimension (EQ-5D-5L)	12 week	Health related quality of life questionnaire. Each dimension of the EQ-5D has 5 levels from 1-5. 1 indicates full health state, 5 indicates worse the problem. The last question, EQ-5D health scale is a scale between 0-100, where 0 indicates worst health, 100 indicates best health.
Visual Analogue Scale	12 week	VAS 10 point scale for self report of pain level. With 1 being no pain and 10 being maximal pain.
Oxford knee/hip score	12 week	Joint specific function questionnaire. The questionnaire contains 6 questions. Each question ranges from 0 to 4, with 4 being the best outcome. The highest score is 48.
Knee flexion/extension strength	12 week	Biodex for isometric strength testing, peak torque will be calculated in N.m
12 steps test	12 week	Time taken to complete 1 flight of 12 steps (s)
Time up and go	12 week	Amount of time taken to complete a lap from sitting to standing, walking for 3 m, turn around a marker and return to sitting position (s)
Sit to stand test	12 week	Number of full repetitions from sitting to standing in a 30s period
Minutes in sedentary activities	1 week baseline and 1 week at completion	Wearable tracking using ActivPAL
4 x 10m walk test	12 week	The average time taken to complete a 10m lap (s)

Trial Locations

Locations (1)

Advanced Wellbeing Research Centre; 🇬🇧 Sheffield, United Kingdom