Motivating patients in cardiac rehabilitation programs: A multicenter randomized controlled trial.
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ABSTRACT:
SUBMITTER: Spindler H
PROVIDER: S-EPMC8287717 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe importance of promoting exercise adherence among individuals with acute coronary syndrome (ACS) is imperative. However, challenges in maintaining behavior among ACS patients are also well-documented. Emerging findings in the general population have supported the use of habit-formation techniques, which include incorporating routine consistency and cues, to be effective for facilitating exercise behavior. The effectiveness of habit formation approaches, however, has not been tested on participants with ACS. The purpose of this study was to test the effectiveness of facilitating physical activity habits among patients with ACS in a two-arm, parallel design, randomized controlled pilot trial.MethodsParticipants (n = 13) were older adult patients (M age = 64.20, SD = 5.35) with ACS who were referred to a cardiac rehabilitation center. The experimental group attended monthly group meetings from months 1-3 and received phone call follow-ups from months 4-6.ConclusionsThe experimental group showed an increase in weekly moderate-to-vigorous level physical activity, M = 228.20 mins (SD = 112.45), compared with the control group, M = 151.17 (SD = 112.22), d = 0.61. The experimental condition also showed greater use of routine consistency (experimental: M = 4.60 (SD = 0.548); control: M = 3.76 (SD = 1.62)) and cue usage (experimental: M = 3.60 (SD = 0.471); control: M= 2.60 (SD = 0.398)) over the control condition at the six-month mark. The study supports the effectiveness of habit-building techniques among patients with ACS, with effect sizes ranging from a medium to large magnitude. Findings from this pilot study support a full clinical trial with larger sample size.
| S-EPMC8296287 | biostudies-literature
Project description:Background: Blocking the action of the pro-inflammatory cytokine interleukin-1 (IL-1) reduces beta-cell secretory dysfunction and apoptosis in vitro, diabetes incidence in animal models of Type 1 diabetes mellitus (T1D), and glycaemia via improved beta-cell function in patients with T2D. We hypothesised that canakinumab, a monoclonal antibody to IL-1B, improves beta-cell function in patients with new-onset T1D. Methods: In an individually randomised, two-group parallel trial involving 12 sites in US, 69 patients aged 6-45 with T1D, < 12 weeks of symptoms, and assigned by centralised computer-generated blocked randomisation with locked computer-file concealment to treatment with 2 mg/kg (maximum 300 mg) canakinumab (n=45) or placebo (n=22) monthly for 12 months as add-on to conventional therapy. Participants and care-givers, but not data monitoring unit, were masked to group assignment. The primary end-point was change in the two-hour area-under-the-curve C-peptide response to MMT 12 months.
2015-10-01 | GSE68049 | GEO
Project description:BackgroundMillions of people in Germany suffer from chronic pain, in which course and intensity are multifactorial. Besides physical injuries, certain psychosocial risk factors are involved in the disease process. The national health care guidelines for the diagnosis and treatment of non-specific low back pain recommend the screening of psychosocial risk factors as early as possible, to be able to adapt the therapy to patient needs (e.g., unimodal or multimodal). However, such a procedure has been difficult to implement in practice and has not yet been integrated into the rehabilitation care structures across the country.MethodsThe aim of this study is to implement an individualized therapy and aftercare program within the rehabilitation offer of the German Pension Insurance in the area of orthopedics and to examine its success and sustainability in comparison to the previous standard aftercare program. The study is a multicenter randomized controlled trial including 1204 patients from six orthopedic rehabilitation clinics. A 2:1 allocation ratio to intervention (individualized and home-based rehabilitation aftercare) versus the control group (regular outpatient rehabilitation aftercare) is set. Upon admission to the rehabilitation clinic, participants in the intervention group will be screened according to their psychosocial risk profile. They could then receive either unimodal or multimodal, together with an individualized training program. The program is instructed in the clinic (approximately 3 weeks) and will continue independently at home afterwards for 3 months. The success of the program is examined by means of a total of four surveys. The co-primary outcomes are the Characteristic Pain Intensity and Disability Score assessed by the German version of the Chronic Pain Grade questionnaire (CPG).DiscussionAn improvement in terms of pain, work ability, patient compliance, and acceptance in our intervention program compared to the standard aftercare is expected. The study contributes to provide individualized care also to patients living far away from clinical centers.Trial registrationDRKS, DRKS00020373 . Registered on 15 April 2020.
| S-EPMC8684145 | biostudies-literature
Project description:BackgroundRehabilitation is crucial for postoperative patients with low back pain (LBP). However, the implementation of traditional clinic-based programs is limited in developing countries, such as China, because of the maldistribution of medical resources. Mobile phone-based programs may be a potential substitute for those who have no access to traditional rehabilitation.ObjectiveThe aim of this study was to examine the efficacy of mobile phone-based rehabilitation systems in patients who underwent lumbar spinal surgery.MethodsPatients who accepted spinal surgeries were recruited and randomized into 2 groups of rehabilitation treatments: (1) a mobile phone-based eHealth (electronic health) program (EH) or (2) usual care treatment (UC). The primary outcomes were (1) function and pain status assessed by the Oswestry Disability Index (ODI) and (2) the visual analog scale (VAS). Secondary outcomes were (1) general mental health and (2) quality of life (Likert scales, EuroQol-5 Dimension health questionnaire, and 36-item Short-Form Health Survey). All the patients were assessed preoperatively and then at 3, 6, 12, and 24 months postoperatively.ResultsA total of 168 of the 863 eligible patients were included and randomized in this study. Our analysis showed that the improvement of primary outcomes in the EH group was superior to the UC group at 24 months postoperatively (ODI mean 7.02, SD 3.10, P<.05; VAS mean 7.59, SD 3.42, P<.05). No significant difference of primary outcomes was found at other time points. A subgroup analysis showed that the improvements of the primary outcomes were more significant in those who completed 6 or more training sessions each week throughout the trial (the highest compliance group) compared with the UC group at 6 months (ODI mean 17.94, SD 5.24, P<.05; VAS mean 19.56, SD 5.27, P<.05), 12 months (ODI mean 13.39, SD 5.32, P<.05; VAS mean 14.35, SD 5.23, P<.05), and 24 months (ODI mean 18.80, SD 5.22, P<.05; VAS mean 21.56, SD 5.28, P<.05).ConclusionsThis research demonstrated that a mobile phone-based telerehabilitation system is effective in self-managed rehabilitation for postoperative patients with LBP. The effectiveness of eHealth was more evident in participants with higher compliance. Future research should focus on improving patients' compliance.Trial registrationChinese Clinical Trial Registry ChiCTR-TRC-13003314; http://www.chictr.org.cn/showproj.aspx?proj=6245 (Archived by WebCite at http://www.webcitation.org/766RAIDNc).
| S-EPMC6404639 | biostudies-literature
Project description:Background: Blocking the action of the pro-inflammatory cytokine interleukin-1 (IL-1) reduces beta-cell secretory dysfunction and apoptosis in vitro, diabetes incidence in animal models of Type 1 diabetes mellitus (T1D), and glycaemia via improved beta-cell function in patients with T2D. We hypothesised that anakinra, a recombinant human IL-1 receptor antagonist, improves beta-cell function in patients with new-onset T1D. Methods: In an individually randomised, two-group parallel trial involving 14 European tertiary referral centers, 69 patients aged 18-35 with T1D, < 12 weeks of symptoms, and standard mixed meal test (MMT) stimulated C-peptide ≥ 200 pM were enrolled between January, 2009 and July, 2011 and assigned by centralised computer-generated blocked randomisation with locked computer-file concealment to treatment with 100 mg anakinra (n=35) subcutaneously once daily or placebo (n=34) for 9 months as add-on to conventional therapy. Participants and care-givers, but not data monitoring unit, were masked to group assignment. The primary end-point was change in the two-hour area-under-the-curve C-peptide response to MMT, and secondary end-points changes in insulin requirements, glycaemia, and inflammatory markers at one, three, six, and nine months. Findings: The study was prematurely terminated due to slow accrual and is closed to follow-up. No interim analysis was performed. Ten patients withdrew in the anakinra and eight in the placebo arm, leaving 25 and 26 patients to be analysed, respectively. There was no statistical difference in adverse event category reporting between arms. Interpretation: Anakinra-treatment in T1D was safe, but the trial failed to meet primary and secondary outcome measures.
2015-10-01 | GSE37025 | GEO
Project description:To determine whether integrative medicine rehabilitation (IMR) that combines conventional rehabilitation (CR) with acupuncture and Chinese herbal medicine has better effects for subacute stroke than CR alone, we conducted a multicenter randomized controlled trial that involved three hospitals in China. Three hundred sixty patients with subacute stroke were randomized into IMR and CR groups. The primary outcome was the Modified Barthel Index (MBI). The secondary outcomes were the National Institutes of Health Stroke Scale (NIHSS), the Fugl-Meyer Assessment (FMA), the mini-mental state examination (MMSE), the Montreal Cognitive Assessment (MoCA), Hamilton's Depression Scale (HAMD), and the Self-Rating Depression Scale (SDS). All variables were evaluated at week 0 (baseline), week 4 (half-way of intervention), week 8 (after treatment) and week 20 (follow-up). In comparison with the CR group, the IMR group had significantly better improvements (P?<?0.01 or P?<?0.05) in all the primary and secondary outcomes. There were also significantly better changes from baseline in theses outcomes in the IMR group than in the CR group (P?<?0.01). A low incidence of adverse events with mild symptoms was observed in the IMR group. We conclude that conventional rehabilitation combined with integrative medicine is safe and more effective for subacute stroke rehabilitation.
| S-EPMC4865744 | biostudies-literature
Project description:BackgroundPatients who have completed Phase II cardiac rehabilitation have low rates of maintenance of exercise after program completion, despite the importance of sustaining regular exercise to prevent future cardiac events.PurposeThe efficacy of a home-based intervention to support exercise maintenance among patients who had completed Phase II cardiac rehabilitation versus contact control was evaluated.DesignAn RCT was used to evaluate the intervention. Data were collected in 2005-2010 and analyzed in 2010.Setting/participantsOne hundred thirty patients (mean age=63.6 years [SD=9.7], 20.8% female) were randomized to exercise counseling (Maintenance Counseling group, n=64) or contact control (Contact Control group, n=66).InterventionMaintenance Counseling group participants received a 6-month program of exercise counseling (based on the transtheoretical model and social cognitive theory) delivered via telephone, as well as print materials and feedback reports.Main outcome measuresAssessments of physical activity (7-Day Physical Activity Recall), motivational readiness for exercise, lipids, and physical functioning were conducted at baseline, 6 months, and 12 months. Objective accelerometer data were collected at the same time points. Fitness was assessed via maximal exercise stress tests at baseline and 6 months.ResultsThe Maintenance Counseling group reported significantly higher exercise participation than the Contact Control group at 12 months (difference of 80 minutes, 95% CI=22, 137). Group differences in exercise at 6 months were nonsignificant. The intervention significantly increased the probability of participants' exercising at or above physical activity guidelines and attenuated regression in motivational readiness versus the Contact Control Group at 6 and 12 months. Self-reported physical functioning was significantly higher in the Maintenance Counseling group at 12 months. No group differences were seen in fitness at 6 months or lipid measures at 6 and 12 months.ConclusionsA telephone-based intervention can help maintain exercise, prevent regression in motivational readiness for exercise, and improve physical functioning in this patient population.
| S-EPMC3160619 | biostudies-literature
Project description:Rehabilitation of patients with chronic obstructive pulmonary disease (COPD) is a key treatment in COPD. However, despite the existing evidence and a strong recommendation from lung associations worldwide, 50% of patients with COPD decline to participate in COPD rehabilitation program and 30-50% drop-out before completion. The main reasons are severe symptoms, inflexible accessibility and necessity for transportation. Currently there are no well-established and evident rehabilitation alternatives. Supervised online screen rehabilitation could be a useful approach to increase accessibility and compliance. The aim of this multicenter RCT study is to compare the potential benefits of a 10-week online COPD rehabilitation program (CORe) with conventional outpatient COPD rehabilitation (CCRe).This study is a randomized assessor- and statistician blinded superiority multicenter trial with two parallel groups, employing 1:1 allocation to the intervention and the comparison group.On the basis of a sample size calculation, 134 patients with severe or very severe COPD and eligible to conventional hospital based outpatient COPD rehabilitation will be included and randomized from eight different hospitals. The CORe intervention group receives group supervised resistance- and endurance training and patient education, 60 min, three times/week for 10 weeks at home via online-screen. The CCRe comparison group receives group based supervised resistance- and endurance training and patient education, 90 min, two times/week for 10 weeks (two hospitals) or 12 weeks (six hospitals) in groups at the local hospital. The primary outcome is change in the 6-min walking distance after 10/12 weeks; the secondary outcomes are changes in 30 s sit-to-stand chair test, physical activity level, symptoms, anxiety and depression symptoms, disease specific and generic quality of life. Primary endpoint is 10/12 weeks from baseline, while secondary endpoints are 22, 36, 62 weeks from baseline assessments.The study will likely contribute to knowledge regarding COPD tele-rehabilitation and to which extent it is more feasible and thereby more efficient than conventional COPD rehabilitation in patients with severe and very severe COPD.Clinicaltrials.gov Identifier: NCT02667171 . Registration data: January 28th 2016.
| S-EPMC5689178 | biostudies-literature
Project description:Between 2004 and 2012, patients with pT1-3, pN0-3, M0 breast tumors were randomised between adjuvant dose-dense doxorubicin-cyclophosphamide (ddAC) versus docetaxel-doxorubicin-cyclophosphamide (TAC). Trial registration numbers: ISRCTN61893718 and BOOG 2004-04.
2021-12-30 | GSE167977 | GEO
Project description:(1) Background: The aim of the present study was to determine the effects of a virtual reality (VR) program, as a complementary tool to a conventional cardiac rehabilitation (CR) program in phase II of patients with ischemic heart disease compared to a conventional treatment group. (2) Methods: A single blinded randomized clinical trial was conducted. The patients were randomized to a control group (CG) or an experimental group (EG). The EG carried out a training based on VR of aerobic exercise using the XBOX ONE console and Kinect sensor. Ergometry, metabolic equivalents (METS), Functional Independence Measure, 6-min walk test (6MWT), the Short Form Health Survey-36 Questionnaire (SF-36), the Beck Depression Inventory-II, and the degree of satisfaction and adherence to treatment were used as outcome measures. (3) Results: Our results showed no statistically significant differences between the two groups. Statistical analysis within group for the EG showed statistically significant changes in the variables HR final ergometry, ergometry minutes, % ergometry, METS, final HR 6MWT, 6MWT distance, 6MWT number of laps, and for the SF-36 and Beck Depression Inventory-II. (4) Conclusion: A VR-based video game program, as an adjunct tool to a CR program, showed improvements in ergometry, METS, resistance to fatigue and health-related quality of life with excellent adherence and satisfaction perceived by patients with ischemic heart disease in phase II.
| S-EPMC7696478 | biostudies-literature