From the Departments of *Physiotherapy and Occupational Therapy Department, Aarhus University Hospital, Denmark †Department of Orthopaedic Surgery, Aarhus University Hospital, Denmark ‡Region Hospital of Silkeborg, Orthopaedic Department, Denmark §Section of Social Medicine and Rehabilitation, Institute of Public Health, Aarhus University, Denmark ¶Public Health and Quality Improvement, Central Denmark Region, Denmark ?CAST-Centre for Applied Health Services Research, University of Southern Denmark, Denmark; and **Institute for Public Health, Aarhus University, Denmark.
Economic evaluation conducted alongside a randomized controlled trial with 1-year follow-up.
To examine the cost-effectiveness of initiating rehabilitation 6 weeks after surgery as opposed to 12 weeks after surgery.
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.
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).
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.
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. .
Heart valve diseases are common with an estimated prevalence of 2.5% in the Western world. The number is rising due to an ageing population. Once symptomatic, heart valve diseases are potentially lethal, and heavily influence daily living and quality of life. Surgical treatment, either valve replacement or repair, remains the treatment of choice. However, post surgery, the transition to daily living may become a physical, mental and social challenge. We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery.
A randomised clinical trial, CopenHeartVR, aims to investigate whether cardiac rehabilitation in addition to usual care is superior to treatment as usual after heart valve surgery. The trial will randomly allocate 210 patients, 1:1 intervention to control group, using central randomisation, and blinded outcome assessment and statistical analyses. The intervention consists of 12 weeks of physical exercise, and a psycho-educational intervention comprising five consultations. Primary outcome is peak oxygen uptake (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. Secondary outcome is self-assessed mental health measured by the standardised questionnaire Short Form 36. Also, long-term healthcare utilisation and mortality as well as biochemistry, echocardiography and cost-benefit will be assessed. A mixed-method design is used to evaluate qualitative and quantitative findings encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study.
The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015).
Neck pain is a major health problem in populations worldwide and an economic burden in modern societies due to its high prevalence and costs in terms of health care expenditures and lost productivity. Massage and exercise therapy are widely used management options for neck pain. However, there is a lack of scientific evidence regarding their effectiveness for subacute and long-lasting neck pain. This study protocol describes a randomized controlled trial aiming to determine the effect of massage and/or exercise therapy on subacute and long-lasting neck pain over the course of 1 year.
A randomized controlled trial in which at least 600 study participants with subacute or long-lasting nonspecific neck pain will be recruited and randomly allocated to one of four treatment arms: massage therapy (A), exercise therapy (B), exercise therapy plus massage therapy (C) and advice to stay active (D). The study has an E-health approach, and study participants are being recruited through advertising with a mix of traditional and online marketing channels. Web-based self-report questionnaires measure the main outcomes at 7, 12, 26 and 52 weeks after inclusion. The primary outcomes are a clinically important improvement in pain intensity and pain-related disability at follow-up, measured with a modified version of the Chronic Pain Questionnaire (CPQ). The secondary outcomes are global improvement, health-related quality of life (EQ-5D), sick leave, drug consumption and healthcare utilization. Adverse events are measured by questionnaires at return visits to the clinic, and automated text messages (SMSes) survey neck pain intensity and pain-related disability every week over one year.
The results of this study will provide clinicians and stakeholders much needed knowledge to plan medical care for subacute and long-lasting neck pain disorders.
Current Controlled Trials ISRCTN01453590. Date of registration: 3 July 2014.
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The purpose of this study was to examine the efficacy of interactive video game stationary cycling (GameBike) in comparison with stationary cycling to music on adherence, energy expenditure measures, submaximal aerobic fitness, body composition, and cardiovascular disease risk markers in overweight and obese adolescents, using a randomized controlled trial design. Thirty overweight (with at least 1 metabolic complication) or obese adolescents aged 12-17 years were stratified by gender and randomized to video game or music condition, with 4 participants (2 per group) failing to complete the twice weekly 60 min sessions of the 10-week trial. The music group had a higher rate of attendance compared with the video game group (92% vs. 86%, p
Few rigorous clinical trials have investigated the effectiveness of exercise on the physical functioning of patients with Alzheimer disease (AD).
To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services.
A randomized controlled trial.
A total of 210 home-dwelling patients with AD living with their spousal caregiver.
The 3 trial arms included (1) group-based exercise (GE; 4-hour sessions with approximately 1-hour training) and (2) tailored home-based exercise (HE; 1-hour training), both twice a week for 1 year, and (3) a control group (CG) receiving the usual community care.
The Functional Independence Measure (FIM), the Short Physical Performance Battery, and information on the use and costs of social and health care services.
All groups deteriorated in functioning during the year after randomization, but deterioration was significantly faster in the CG than in the HE or GE group at 6 (P = .003) and 12 (P = .015) months. The FIM changes at 12 months were -7.1 (95% CI, -3.7 to -10.5), -10.3 (95% CI, -6.7 to -13.9), and -14.4 (95% CI, -10.9 to -18.0) in the HE group, GE group, and CG, respectively. The HE and GE groups had significantly fewer falls than the CG during the follow-up year. The total costs of health and social services for the HE patient-caregiver dyads (in US dollars per dyad per year) were $25,112 (95% CI, $17,642 to $32,581) (P = .13 for comparison with the CG), $22,066 in the GE group ($15,931 to $28,199; P = .03 vs CG), and $34,121 ($24,559 to $43,681) in the CG.
An intensive and long-term exercise program had beneficial effects on the physical functioning of patients with AD without increasing the total costs of health and social services or causing any significant adverse effects.
anzctr.org.au Identifier: ACTRN12608000037303.
Comment In: Ann Intern Med. 2013 Aug 20;159(4):JC1024026274
Comment In: MMW Fortschr Med. 2013 Nov 7;155(19):3224475662
Comment In: JAMA Intern Med. 2013 May 27;173(10):901-223588877
Despite an extensive literature on treatment interventions for patients with knee osteoarthritis, studies comparing the efficacy of different exercise interventions and living the life as usual on quality of life, cartilage quality and cost-effectiveness are lacking. The aim of the present study is to compare the efficacy of two different exercise programs compared to a control group in individuals with established radiographic and symptomatic knee osteoarthritis on self-reported knee-related quality of life, knee pain, physical function, and cartilage quality.
A three-armed randomized controlled trial involving two exercise interventions and a control group of individuals doing as they usually do is described. The patients will have mild to moderate radiographic osteoarthritis according to the Kellgren and Lawrence classification (grade 2-3), and fulfill the American College of Rheumatology clinical criteria, be aged between 45 and 65 years, and have no other serious physical or mental illnesses. The patients will be randomly allocated to a strength exercise group; a cycling group, or a control group. The primary outcome is the Knee injury and Osteoarthritis Outcome Score knee-related quality of life subscale. Secondary outcomes include all five Knee Injury and Osteoarthritis Outcome Score subscales, morphological evaluation of cartilage including focal thickness, subchondral bone marrow edema, proteoglycan content and collagen degradation (measured using magnetic resonance imaging clinical sequences, T2 mapping and T1?), specific serum biomarkers, isokinetic muscle strength, maximal oxygen uptake, quality of life (EuroQol 5D), and self-efficacy (Arthritis Self-Efficacy Scale). A sample size calculation on the primary outcome showed that 207 individuals, 69 in each group, is needed to detect a clinically relevant difference of 10 points with 80% power and a significance level of 5%. Assessments will be conducted at baseline, 14 weeks, 1 year and 2 years post-randomization. The interventions will be a 14 weeks exercise program.
Although exercise therapy has been found to be effective in knee osteoarthritis, the knowledge of the underlying mechanisms for why exercise works is lacking. This study will contribute with knowledge on the efficacy of strength exercise versus cycling on patient-reported outcomes, cartilage quality and cost-effectiveness.
Clinicaltrial.gov Identifier: NCT01682980.
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Efficiency and costs of medical exercise therapy, conventional physiotherapy, and self-exercise in patients with chronic low back pain. A pragmatic, randomized, single-blinded, controlled trial with 1-year follow-up.
STUDY DESIGN: A multicenter, randomized, single-blinded controlled trial with 1-year follow-up. OBJECTIVES: To evaluate the efficiency of progressively graded medical exercise therapy, conventional physiotherapy, and self-exercise by walking in patients with chronic low back pain. SUMMARY AND BACKGROUND DATA: Varieties of medical exercise therapy and conventional physiotherapy are considered to reduce symptoms, improve function, and decrease sickness absence, but this opinion is controversial. METHODS: Patients with chronic low back pain or radicular pain sick-listed for more than 8 weeks and less than 52 weeks (Sickness Certificate II) were included. The treatment lasted 3 months (36 treatments). Pain intensity, functional ability, patient satisfaction, return to work, number of days on sick leave, and costs were recorded. RESULTS: Of the 208 patients included in this study, 71 were randomly assigned to medical exercise therapy, 67 to conventional physiotherapy, and 70 to self-exercise. Thirty-three (15.8%) patients dropped out during the treatment period. No difference was observed between the medical exercise therapy and conventional physiotherapy groups, but both were significantly better than self-exercise group. Patient satisfaction was highest for medical exercise therapy. Return to work rates were equal for all 3 intervention groups at assessment 15 months after therapy was started, with 123 patients were back to work. In terms of costs for days on sick leave, the medical exercise therapy group saved 906,732 Norwegian Kroner (NOK) ($122,531.00), and the conventional physiotherapy group saved NOK 1,882,560 ($254,200.00), compared with the self-exercise group. CONCLUSIONS: The efficiency of medical exercise therapy and conventional physiotherapy is shown. Leaving patients with chronic low back pain untampered poses a risk of worsening the disability, resulting in longer periods of sick leave.
Besides cognitive decline, Alzheimer's disease (AD) leads to physical disability, need for help and permanent institutional care. The trials investigating effects of exercise rehabilitation on physical functioning of home-dwelling older dementia patients are still scarce. The aim of this study is to investigate the effectiveness of intensive exercise rehabilitation lasting for one year on mobility and physical functioning of home-dwelling patients with AD.
During years 2008-2010, patients with AD (n = 210) living with their spousal caregiver in community are recruited using central AD registers in Finland, and they are offered exercise rehabilitation lasting for one year. The patients are randomized into three arms: 1) tailored home-based exercise twice weekly 2) group-based exercise twice weekly in rehabilitation center 3) control group with usual care and information of exercise and nutrition. Main outcome measures will be Guralnik's mobility and balance tests and FIM-test to assess physical functioning. Secondary measures will be cognition, neuropsychiatric symptoms according to the Neuropsychiatric Inventory, caregivers' burden, depression and health-related quality of life (RAND-36). Data concerning admissions to institutional care and the use and costs of health and social services will be collected during a two year follow-up.
To our knowledge this is the first large scale trial exploring whether home-dwelling patients with AD will benefit from intense and long-lasting exercise rehabilitation in respect to their mobility and physical functioning. It will also provide data on cost-effectiveness of the intervention.
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The Copenhagen Outpatient ProgrammE - implantable cardioverter defibrillator (COPE-ICD) trial included patients with implantable cardioverter defibrillators in a randomized controlled trial of rehabilitation. After 6-12 months significant differences were found in favour of the rehabilitation group for exercise capacity, general and mental health. The aim of this paper is to explore the long-term health effects and cost implications associated with the rehabilitation programme; more specifically, (i) to compare implantable cardioverter defibrillator therapy history and mortality between rehabilitation and usual care groups; (ii) to examine the difference between rehabilitation and usual care groups in terms of time to first admission; and (iii) to determine attributable direct costs.
Patients with first-time implantable cardioverter defibrillator implantation (n?=?196) were randomized (1:1) to comprehensive cardiac rehabilitation or usual care. Outcomes were measured by implantable cardioverter defibrillator therapy history from patient records and national register follow-up on mortality, hospital admissions and costs.
No significant differences were found after 3 years for implantable cardioverter defibrillator therapy or mortality between rehabilitation and usual care. Time to first admission did not differ. The cost of rehabilitation was 335 USD/276 Euro per patient enrolled in rehabilitation. The total attributable cost of rehabilitation after 3 years was -6,789 USD/-5,593 Euro in favour of rehabilitation.
No long-term health outcome benefits were found for the rehabilitation programme. However, the rehabilitation programme resulted in a reduction in total attributable direct costs.