An exercise and patient education intervention to reduce pain and physical limitations in adults with acetabular dysplasia: study protocol for a process evaluation integrated within a randomised controlled trial (the MovetheHip trial).

BACKGROUND: The Movethehip trial investigates the effectiveness of an exercise and patient education intervention for adults with acetabular dysplasia. The intervention involves eight tailored one-to-one sessions with trained providers who employ supportive feedback tools. The present protocol reports a planned process evaluation, which aims to determine how the intervention functions by examining the implementation of the intervention (process, dose and reach), its acceptability, mechanisms of change and the influence of contextual factors. METHODS: Two hundred trial participants aged 18-50 years will be recruited from a University Hospital in Denmark and randomised to the intervention or control group. Approximately ten providers will deliver the intervention. The process evaluation adopts a concurrent mixed-methods design. The implementation will be assessed using self-report questionnaires (at baseline and 6-month follow-up), training records and semi-structured focus group interviews with intervention providers (n = 10) and healthcare managers (n = 4-6). The mechanisms of change will be explored through semi-structured one-to-one interviews (at baseline and 6-month follow-up) with 15-20 purposefully sampled participants and by measuring changes in health outcomes (self-reported pain, physical functioning and quality of life completed at baseline and at 3- and 6-month follow-up). Additionally, change will be measured through an explorative examination of associations between dose and change in health outcomes, applying simple linear regression models. The acceptability of the intervention and the influence of contextual factors will be explored through one-to-one participant interviews and focus group interviews with 4-6 healthcare managers. The interviews will focus on expectations, experiences, events, personal understandings and interaction with interpersonal and organisational aspects. Interview data will be analysed using theoretical thematic analyses, and findings will be merged with quantitative data and reported jointly on a theme-by-theme basis. DISCUSSION: The process evaluation conducted as part of the MovetheHip trial will illuminate how the intervention functions, and if the intervention is proven effective, the findings of the evaluation will contribute to pinpoint how the intervention may be optimised to facilitate future up-scaling and implementation. TRIAL REGISTRATION: The MovetheHip protocol was approved by the Committee on Health Research Ethics in the Central Denmark Region. ClinicalTrials, NCT04795843. Registered on 20 March 2021.

Feasibility and acceptability of a six-month exercise and patient education intervention for patients with hip dysplasia: A mixed methods study.

BACKGROUND AND OBJECTIVES: To evaluate the feasibility and acceptability of exercise and patient education for patients with hip dysplasia not receiving surgery. DESIGN: Feasibility study. METHODS: The participants received exercise instruction and patient education over six months. Feasibility covered recruitment, retention, and mechanisms of change (MC). MC were measured with Hip and Groin Outcome Score (HAGOS), muscle strength tests, Y-balance test, and hop for distance test (HDT) over six months. Acceptability covered adherence, expectations, perceptions, benefits, and harms. RESULTS: Thirty of 32 were recruited (median age: 30 years); six were lost to follow-up. Twenty-four participants improved by a mean of 11 (95%CI: 5-17) HAGOS pain points, improvements in all subscales were 1-11 points. Mean hip abduction strength improved 0.2 (95%CI: 0.04-0.4) Nm/kg, similar to flexion and extension. Median Y-balance test improvements: anterior: 70 (IQR: 64-74) to 75 (IQR: 72-80) centimetres; posteromedial: 104 (IQR: 94-112) to 119 (IQR: 112-122) centimetres and posterolateral: 98 (IQR: 89-109) to 116 (IQR: 108-121) centimetres (p < .001). Median improvement in HDT was: 37 (IQR: 30-44) to 52 (IQR: 45-58) centimetres (p < .001). Participants adhered to 84% of scheduled sessions (1,581:1,872), expectations were met, and perceptions were characterized by high self-efficacy for exercise. Benefits were reported with no serious harms. CONCLUSION: Patients with hip dysplasia are willing to be recruited for exercise and patient education, with acceptable retention. MC were observed through improvements in pain, strength and function with high acceptance of the exercise and patient education intervention. Thus, it seems feasible to conduct a full-scale randomised controlled trial.

Responsiveness and minimal important change of the Oxford Shoulder Score, EQ-5D, and the Fear-Avoidance Belief Questionnaire Physical Activity subscale in patients undergoing arthroscopic subacromial decompression.

INTRODUCTION: Adequate responsiveness and knowledge of the minimal important change (MIC) is essential when using patient-reported outcome measures to assess treatment efficacy. OBJECTIVE: The objective of this study was to evaluate the responsiveness and MIC of common outcomes in patients with subacromial impingement syndrome undergoing arthroscopic subacromial decompression. METHODS: At baseline and 6 months after surgery, patients completed the Oxford Shoulder Score (OSS), EQ-5D 5-level utility index, EQ visual analogue scale, Fear-Avoidance Belief Questionnaire Physical Activity subscale (FABQ-PA), assessed pain (pain visual analogue scale), and Subjective Shoulder Value. Furthermore, at the 6-month follow-up, patients assessed the overall change with a Global Rating of Change Scale. Responsiveness was examined by analyzing the area under the receiver operating characteristics curve and correlations between the change scores. MIC was assessed using the optimal cutoff point at the receiver operating characteristics curve. RESULTS: Area under the receiver operating characteristics curve estimates were 0.96 (95% confidence interval [CI] 0.91,1.00) for OSS, 0.82 (95% CI 0.66,0.99) for EQ-5D 5-level utility index, 0.73 (95% CI 0.58,0.87) for EQ visual analogue scale, and 0.74 (95% CI 0.58,0.90) for FABQ-PA. MIC were 6.0 points for OSS, 0.024 points for EQ-5D 5-level utility index, 10.0 points for EQ visual analogue scale, and -5.0 points for FABQ-PA. CONCLUSION: Responsiveness of the OSS, EQ-5D, and FABQ-PA was sufficient to measure improvement after arthroscopic decompression surgery.

Telemonitored exercise-based cardiac rehabilitation improves physical capacity and health-related quality of life.

INTRODUCTION: Cardiac rehabilitation improves physical capacity, health-related quality of life, and reduces morbidity and mortality among cardiac patients. Telemonitored exercise-based cardiac rehabilitation may innovate existing programmes and increase participation rates. OBJECTIVE: The purpose of this study was to investigate if telemonitored exercise-based cardiac rehabilitation improves physical capacity, muscle endurance, muscle power, muscle strength and health-related quality of life in cardiac patients. METHODS: A follow-up study on moderate risk patients with ischaemic heart and heart valve disease referred to a 12-week telemonitored exercise-based cardiac rehabilitation intervention at Aarhus University Hospital (Denmark). Participants were encouraged to exercise 60 min three times weekly with moderate/high intensity for 20 min per session. Intensity and duration of training sessions were visualised on a smartphone and uploaded to a website. Participants received individual feedback from physiotherapists on their training efforts by telephone/email. Outcome measures were changes in physical capacity (peak oxygen uptake), muscle endurance, power, and strength, and health-related quality of life between baseline end of telemonitored exercise-based cardiac rehabilitation intervention, and at six and 12 months after end of telemonitored exercise-based cardiac rehabilitation. RESULTS: Thirty-four participants completed telemonitored exercise-based cardiac rehabilitation. We identified a significant increase in peak oxygen uptake of 10%, in muscle endurance of 17%, in muscle power of 7%, and in muscle strength of 10% after the telemonitored exercise-based cardiac rehabilitation programme. Health-related quality of life was significantly improved by 19% in the physical and 17% in the mental component scores. We found no significant improvement in peak oxygen uptake between baseline and 12 months follow-up, but a significant improvement in muscle endurance (0.3 watts/kg, 95% confidence interval; 0.2-0.4), muscle power (0.4 watts/kg; 0.2-0.5), muscle strength (0.5 N/m/kg; 0.1-0.9), physical health-related quality of life (five points; 2-8) and mental health-related quality of life (six points; 3-9). DISCUSSION: This study demonstrated that the self-elected type of physical exercise in cardiac rehabilitation with telemonitoring improved all outcome measures both on the short and long-term, except for peak oxygen uptake at 12 months follow-up.

Reliability and internal consistency of the Danish version of Loewenstein Occupational Therapy Cognitive Assessment 2nd Edition (LOTCA-II/D).

OBJECTIVE: To evaluate the intra-rater and inter-rater reliability and internal consistency of the Danish version of the Loewenstein Occupational Therapy Cognitive Assessment, second edition (LOTCA-II/D), an instrument designed to assess and evaluate cognitive functioning. METHODS: A reliability study was conducted at neurological acute care and rehabilitation units at three Danish hospitals. Fifty-four neurological patients participated in the study. Patients were tested with LOTCA-II/D by occupational therapists, and video recordings were made for reliability assessments. Intra-rater assessments were performed at least two weeks after the first assessment, and all occupational therapists were blinded to previous assessments. Intra-rater and inter-rater reliability were evaluated using percentage agreement and weighted kappa. Internal consistency was evaluated using Cronbach's alpha, and floor and ceiling effects were evaluated by calculating the proportion of observations in minimum and maximum categories of subtests. RESULTS: The results showed a lack of intra-rater and inter-rater reliability and a large variation of agreement due to a substantial ceiling effect. Internal consistency was below the acceptable value in half of the cognitive areas. CONCLUSION: The study found that LOTCA-II/D is not reliable in acute clinical practice, and it could thus not be validated for use in this setting.

Early versus late initiation of rehabilitation after lumbar spinal fusion: economic evaluation alongside a randomized controlled trial.

STUDY DESIGN: Economic evaluation conducted alongside a randomized controlled trial with 1-year follow-up. OBJECTIVE: To examine the cost-effectiveness of initiating rehabilitation 6 weeks after surgery as opposed to 12 weeks after surgery. SUMMARY OF BACKGROUND DATA: In a previously reported randomized controlled trial, we assessed the impact of timing of rehabilitation after a lumbar spinal fusion and found that a fast-track strategy led to poorer functional ability. Before making recommendations, it seems relevant to address the societal perspective including return to work, quality of life, and costs. METHODS: A cost-effectiveness analysis and a cost-utility analysis were conducted. Eighty-two patients undergoing instrumented lumbar spinal fusion due to degenerative disc disease or spondylolisthesis (grade I or II) were randomized to an identical protocol of 4 sessions of group-based rehabilitation and were instructed in home exercises focusing on active stability training. Outcome parameters included functional disability (Oswestry Disability Index) and quality-adjusted life years. Health care and productivity costs were estimated from national registries and reported in euros. Costs and effects were transformed into net benefit. Bootstrapping was used to estimate 95% confidence intervals (95% CI). RESULTS: The fast-track strategy tended to be costlier by €6869 (95% CI, -4640 to 18,378) while at the same time leading to significantly poorer outcomes of functional disability by -9 points (95% CI, -18 to -3) and a tendency for a reduced gain in quality-adjusted life years by -0.04 (95% CI, -0.13 to 0.01). The overall probability for the fast-track strategy being cost-effective does not reach 10% at conventional thresholds for cost-effectiveness. CONCLUSION: Initiating rehabilitation at 6 weeks as opposed to 12 weeks after surgery is on average more costly and less effective. The uncertainty of this result did not seem to be sensitive to methodological issues, and clinical managements who have already adapted fast-track rehabilitation strategies have reason to reconsider their choice. .

The effect of timing of rehabilitation on physical performance after lumbar spinal fusion: a randomized clinical study.

BACKGROUND: The number of patients undergoing lumbar spinal fusion procedures (LSF) has risen in recent years, but only few studies have examined different rehabilitation strategies for this patient group. PURPOSE: To evaluate the impact of initiating rehabilitation either 6 or 12 weeks after a LSF based on the patients' physical performance using the 6-min walking test (6MWT) and the Åstrand Fitness test (AF-test) as measurement. METHODS: A multicentre RCT including 82 patients with degenerative disc diseases undergoing LSF randomly assigned to initiate rehabilitation either 6 or 12 weeks after surgery. Both groups received the same group-based rehabilitation. The main outcome measures were the 6MWT and the AF-test, secondarily questionnaire-based measures. Follow-up at baseline as well as at 3, 6 and 12 months after surgery. RESULTS: Comparing the two groups no statistically significant difference was found in walking distance or fitness over time. In both groups, the patients achieved an overall increase in walking distance (p < 0.01), but no improvement in fitness. The 6MWT showed significant correlation (-0.37 to -0.59) with the questionnaire-based outcome measures (p < 0.01). The AF-test did not correlate to either the 6MWT or any of the questionnaire-based outcome measures. CONCLUSION: No difference was found in the effect of initiating rehabilitation either 6 or 12 weeks after LSF on the patients' physical performance in terms of fitness and walking distance. The 6MWT showed fair to moderate correlation to the questionnaire-based outcome measures. The AF-test showed no significant independent value, and we question its use in LSF patients.

The effect of early initiation of rehabilitation after lumbar spinal fusion: a randomized clinical study.

STUDY DESIGN: A multicenter randomized clinical trial including 82 patients. OBJECTIVE: To examine the effect of early initiation of rehabilitation after instrumented lumbar spinal fusion. SUMMARY OF BACKGROUND DATA: Lumbar spinal fusion has been performed for more than 70 years. Yet, few studies have examined patients' subsequent rehabilitation. Group-based rehabilitation is both efficient and cost-effective in rehabilitation of lumbar spinal fusion patients. METHODS: Patients with degenerative disc diseases undergoing instrumented lumbar spinal fusion were randomly assigned to initiate their rehabilitation 6 weeks (6-wk group) or 12 weeks after lumbar spinal fusion (12-wk group). Both groups received the same group-based rehabilitation. Primary outcome was the Oswestry Disability Index. Secondary outcome was the Dallas Pain Questionnaire, the Low Back Pain Rating Scale, and absence from work. Wilcoxon rank-sum test was used to compare the groups in terms of differences from baseline to 6 months and 1-year follow-up. Results are presented in median with 25th and 75th percentiles. RESULTS: According to the Oswestry Disability Index, at 1-year follow-up, the 6-week-group had a median reduction of -6 (-19; 4) compared with -20 (-30;-7) in the 12-week group (P, 0.05). The Dallas Pain Questionnaire showed overall the same tendency, and within daily activities were significantly reduced in favor of the 12-week group (P, 0.05). For back pain, the 6-week group had a median reduction of -2.2 (-3.0; -0.7) similar with -3.3 (-4.7; -1.7) in the 12-week group (P, 0.05). The results at 6 months of follow-up were similar. No difference was found according to return to work 1 year postsurgery. CONCLUSION: Early start of rehabilitation (6 wk vs. 12 wk) after lumbar spinal fusion resulted in inferior outcomes. The improvements in the 12-week group were 4 times better than that in the 6-week group, indicating that the start-up time of rehabilitation is an important contributing factor for the overall outcome.