IMPORTANCE Clinical practice guidelines support exercise for patients with Parkinson disease (PD), but to our knowledge, no randomized clinical trials have tested whether yoga is superior to conventional physical exercises for stress and symptom management.OBJECTIVE To compare the effects of a mindfulness yoga program vs stretching and resistance training exercise (SRTE) on psychological distress, physical health, spiritual well-being, and health-related quality of life (HRQOL) in patients with mild-to-moderate PD.DESIGN, SETTING, AND PARTICIPANTS An assessor-masked, randomized clinical trial using the intention-to-treat principle was conducted at 4 community rehabilitation centers in Hong Kong between December 1, 2016, and May 31, 2017. A total of 187 adults (aged Ն18 years) with a clinical diagnosis of idiopathic PD who were able to stand unaided and walk with or without an assistive device were enrolled via convenience sampling. Eligible participants were randomized 1:1 to mindfulness yoga or SRTE. INTERVENTIONS Mindfulness yoga was delivered in 90-minute groups and SRTE were delivered in 60-minute groups for 8 weeks. MAIN OUTCOMES AND MEASURES Primary outcomes included anxiety and depressive symptoms assessed using the Hospital Anxiety and Depression Scale. Secondary outcomes included severity of motor symptoms (Movement Disorder Society Unified Parkinson's Disease Rating Scale [MDS-UPDRS], Part III motor score), mobility, spiritual well-being in terms of perceived hardship and equanimity, and HRQOL. Assessments were done at baseline, 8 weeks (T1), and 20 weeks (T2). RESULTSThe 138 participants included 65 men (47.1%) with a mean (SD) age of 63.7 (8.7) years and a mean (SD) MDS-UPDRS score of 33.3 (15.3). Generalized estimating equation analyses revealed that the yoga group had significantly better improvement in outcomes than the SRTE group, particularly for anxiety (time-by-group
BackgroundPsychological distress is prevalent among people with Parkinson’s disease (PD) and aggravates their motor symptoms, thereby leading to increased disability, high healthcare costs, and poor health-related quality of life (HRQoL). The under-recognition and adverse effects of the pharmacological management of anxiety and depression among the PD population are considerable. Thus, adopting a Complementary and Alternative Management (CAM) approach to address this problem is important. Yoga, one of the most common “mind-body” CAM therapies, can improve the psychological wellbeing of people with chronic illnesses. However, limited research on the effects of yoga in people with PD has been conducted. This study will determine the effects of yoga on the psychological wellbeing of people with mild-to-moderate PD and will compare these effects with those of stretching and resistance training exercises.MethodsA community-based, single-blind, randomized trial will be conducted. A total of 126 subjects will be recruited and randomly divided into yoga (n = 63) or stretching and resistance exercise (n = 63) groups. For 8 weeks, the yoga group will receive a weekly 90-min session of yoga, and the control group will receive a weekly 60-min session of stretching and resistance exercises. The primary outcome will be the level of psychological distress measured using the Hospital Anxiety and Depression Scale. The secondary outcomes will include the severity of motor symptoms measured by the Movement Disorders Society – Unified Parkinson’s Disease Scale − Part III Motor Examination; mobility, balance, and fall risk measured by the Timed Up and Go test; spiritual wellbeing measured by the Holistic Wellbeing Scale; and HRQoL measured by the Parkinson’s Disease Questionnaire-8. Assessment will be conducted at baseline, 8th, and 20th weeks of follow-ups.DiscussionThis study will be the first randomized trial to compare the effect of yoga versus stretching and resistance training exercises in a PD population. Results will contribute to the value of yoga as a therapeutic option for managing psychological distress in PD patients. Multiple outcomes including psychological, physiological, and spiritual and HRQoL will also be measured to elucidate the potential mechanisms of yoga. The effect of yoga on people with chronic illnesses will further be elucidated. This information should contribute to future research, practice, and policy related to PD management.Trial registrationWHO Primary Registry – Chinese Clinical Trials Registry (ChiCTR): CUHK_CCRB00522 Registered on 8 October 2016; date of approval 19 August 2016.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-017-2223-x) contains supplementary material, which is available to authorized users.
Clinical practice guidelines support resilience training and exercise for patients with Parkinson’s disease (PD). This assessor-blinded, randomized clinical trial aimed to compare the effects of a modified mindfulness meditation program versus stretching and resistance training exercise (SRTE) in patients with mild-to-moderate PD. A total of 126 potential participants were enrolled via convenience sampling, of which 68 eligible participants were randomized 1:1 to receive eight weekly 90-min sessions of mindfulness meditation or SRTE. Compared to the SRTE group, generalized estimating equation analyses revealed that the mindfulness group had significantly better improvement in outcomes, particularly for improving depressive symptoms (d, −1.66; 95% CI, −3.31 to −0.02) at week 8 and maintaining emotional non-reactivity at week 20 (d, 2.08; 95% CI, 0.59 to 3.56). Both groups demonstrated significant immediate, small-moderate effects on cognition (effect size [d] = 0.36–0.37, p = 0.006–0.011). Compared with the SRTE, mindfulness meditation appeared to be a feasible and promising strategy for managing depressive symptoms and maintaining emotional stability, with comparable benefits on cognitive performance. To combat the psychospiritual and cognitive sequelae of social unrest and COVID-19 pandemic, the integration of mindfulness training into motor-oriented PD rehabilitation protocols is recommended to strengthen the resilience and minimize the psycho-cognitive comorbidities among patients with mild-to-moderate PD.Trial Registration: HKU Clinical Trials Registry identifier: HKUCTR-2681.
Background Although several studies have reported positive effects of mind-body exercises on symptom management and health-related quality of life (HRQOL) of people living with Parkinson’s disease (PD), it is not known whether these effects are attributable to a change in anxiety and depression. Purpose To compare the effects of mindfulness yoga to conventional stretching exercises in a randomized controlled trial while examining potentially mediating effects of anxiety and depression. Methods 138 adults with PD were randomized to eight weekly yoga (n = 71) or stretching (n = 67) sessions. Symptom experiences, anxiety and depression, and HRQOL outcomes were assessed at baseline, immediate post-intervention, and 3-month post-intervention. Results Generalized estimating equation analyses revealed that, compared to stretching, yoga significantly improved patients’ nonmotor (time-by-group interaction, T1:β = −1.99, p = .008; T2:β = −2.86, p < .001) and motor (time-by-group interaction, T1:β = −1.77, p = .03) symptom experiences. The mediation analysis found that the changes in anxiety and depression were the mediators in the associations between non-motor experience and HRQOL; while only the changes in depression were found to be the mediator in the relationship between motor experience and HRQOL. Conclusions Yoga is superior to conventional stretching exercises in improving nonmotor and motor symptoms in daily living. Reduced anxiety and depression play a role in mediating the positive effects of the mindfulness yoga intervention. To optimize HRQOL, rehabilitation should reinforce psychological care in addition to pharmacological treatments and physical relief of PD symptoms. Future studies are needed to identify strategies for facilitating the implementation and sustainability of mind-body rehabilitation to enhance the quality of care for PD.
Background Multiple systematic reviews have reported that self-management interventions are associated with positive impacts on self-efficacy and health-related quality of life (HRQoL) of people with stroke. Purpose This article reports the effects of an enhanced stroke self-management program. Methods Eligible adults with stroke were recruited from community-based organizations and a support group for a two-arm, assessor-blinded randomized controlled trial. Participants in the control group received usual care, while those in the intervention group also received the 8-week self-management program, Coaching Ongoing Momentum Building On stroKe rEcovery journeY (COMBO-KEY), consisting of four individual home visits and five follow-up phone calls, delivered by healthcare professionals and trained volunteers. Assessments were conducted at baseline and after the intervention, for outcomes of self-efficacy, satisfaction with the performance of self-management behaviors, HRQoL, and community reintegration, which were analyzed using generalized estimating equations (GEEs). Results 134 Participants were recruited [mean age = 64.1 years, standard deviation (SD) = 12.7]. Over 80% of the participants had a first-ever stroke [mean years after first stroke: 4.2 (SD = 5.1)]. The GEE analysis revealed that the intervention group participants showed significantly greater improvements in self-efficacy, satisfaction with their performance of self-management behaviors, HRQoL, and community reintegration at 8-week follow-up with respect to their baseline levels. Conclusions The COMBO-KEY program showed effective improvements in recovery outcomes of people with stroke. Future research should explore the inclusion of virtual/hybrid sessions, strategies to assess health conditions of people with stroke via online modes, and assessment of goal attainment and actual performance of self-management behaviors.
IntroductionSystematic reviews reporting self-management interventions are associated with significant improvements in stroke survivors’ self-efficacy, health-related quality of life (HRQoL) and independence. However, common barriers such as transportation and availability of carers were identified. Health coaching is suggested as an innovative and cost-effective care model with potential benefits in managing chronic diseases. A randomised controlled trial is proposed to evaluate the effectiveness of an enhanced self-management programme by health coaches on stroke survivors’ recovery outcomes.Methods and analysisAll adult community-dwelling stroke survivors with a modified Rankin Scale Score ≥3 will be recruited from a community rehabilitation network. Eligible participants will be randomly allocated to receive either the enhanced stroke self-management programme (Coaching Ongoing Momentum Building On stroKe rEcovery journeY [COMBO-KEY]) plus usual care or usual care only. COMBO-KEY is an 8-week programme underpinned by Bandura’s principles of self-efficacy and outcome expectation. It consists of four home visits and five phone-coaching sessions delivered by trained health coaches. Each participant will receive a resource package containing a workbook, a quick reference guide, a planning toolkit and 15 videos of peer survivors’ stroke survival experience. Survivors’ outcomes include self-efficacy, outcome expectation and satisfaction with performance of self-management behaviours, HRQoL, depressive symptoms and community reintegration. Assessment will be conducted at baseline and immediately after completing the programme. Generalised estimating equations' model will be used to analyse the data.DiscussionIt is anticipated that the programme will build community capacity in supporting stroke survivors. The results will shed light on integrating the programme into the current stroke rehabilitation services.Ethics and disseminationThe Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee has approved this protocol (CREC Ref. No.: 2018.009). Written informed consent will be obtained from all participants. Study results will be disseminated through peer-reviewed journals and presentations at local and international conferences.Trial registration numberClinicalTrials.gov Identifier:NCT03741842; Pre-results
Introduction: Systematic reviews show that self-management interventions were associated with significant improvements in stroke survivors’ activities of daily living and quality of life. However, the programmes were largely group-based and held in community settings. It may limit access by stroke survivors who have greater physical impairment or are more vulnerable to adverse events. Aim: This study aimed to develop and evaluate the effects of a new, 8-week, individual-based self-management program on stroke survivors’ self-efficacy in performing self-management behaviors and level of community reintegration. Methods: A 2-arm randomized controlled trial was conducted. A convenience sample of adults who had a first-ever/recurrent ischemic/hemorrhagic stroke were recruited from community-based rehabilitation organisations and support groups. The participants in the intervention group received the self-management program and usual care. The program included four home visits and five phone coaching sessions held weekly over eight weeks. It was led by a healthcare professional who conducted home visits and supported by a trained volunteer who provided phone coaching. Access to the program website and a workbook with essential information about self-management and peer survivors’ sharing of survival experiences in videos was also provided. The generalised estimating equations (GEE) model was used to compare the difference in outcomes between the intervention and control groups at post-intervention compared to baseline. Results: A total of 134 participants (mean age=64.06 years; SD=12.69) were recruited. The mean years after a stroke was 4.19 years (SD=5.07). The adjusted GEE analysis results showed that participants in the intervention group improved significantly more in total scores of the Stroke Self-Efficacy Questionnaire and the Reintegration into Normal Living Index at follow-up with respect to baseline compared to those in the control group. Conclusions: The results supported the benefits of the self-management program. The model of collaboration between healthcare professionals and trained volunteers in the program delivery could be further explored to optimize the continuity of self-management support to stroke survivors.
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