A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia.
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SUBMITTER: Carson JW
PROVIDER: S-EPMC5568071 | biostudies-other | 2010 Nov
REPOSITORIES: biostudies-other
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Project description:ObjectivesThe purpose of this randomized controlled trial was to evaluate the effects of a specialized yoga program for individuals with a spinal cord injury (SCI) on pain, psychological, and mindfulness variables.Materials and methodsParticipants with SCI (n=23) were outpatients or community members affiliated with a rehabilitation hospital. Participants were randomized to an Iyengar yoga (IY; n=11) group or to a 6-week wait-list control (WLC; n=12) group. The IY group participated in a twice-weekly 6-week seated IY program; the WLC group participated in the same yoga program, after the IY group's yoga program had ended. Pain, psychological, and mindfulness measures were collected at two time points for both groups (within 1-2 weeks before and after program 1 and at a third time point for the WLC group (within 1 week after program 2).ResultsLinear mixed-effect growth models were conducted to evaluate the main effects of group at T2 (postintervention), controlling for T1 (preintervention) scores. T2 depression scores were lower (F1,18=6.1, P<0.05) and T2 self-compassion scores higher (F1,18=6.57, P< 0.05) in the IY group compared to the WLC group. To increase sample size and power, the two groups were combined and analyzed across time by comparing pre- and postintervention scores. Main effects of time were found for depression scores, (F1,14.83=6.62, P<0.05), self-compassion, (F1,16.6=4.49, P<0.05), mindfulness (F1,16.79=5.42, P<0.05), mindful observing (F1,19.82=5.06, P<0.05), and mindful nonreactivity, (F1,16.53=4.92, P<0.05), all showing improvement after the intervention.DiscussionThe results indicated that a specialized 6-week yoga intervention reduced depressive symptoms and increased self-compassion in individuals with SCI, and may also have fostered greater mindfulness.
| S-EPMC5422575 | biostudies-literature
Project description:BackgroundConventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression.MethodsInvestigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks.ResultsIn intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES.ConclusionIn adults with mild-to-moderate major depression, an 8-week hatha yoga intervention resulted in statistically and clinically significant reductions in depression severity.Trial registrationClinicalTrials.gov NCT01210651.
| S-EPMC5354384 | biostudies-literature
Project description:Affect and how it is regulated plays a role in pain perception, maintenance of pain, and its resolution. This randomized, controlled trial evaluated an innovative affective self-awareness (ASA) intervention, which was designed to reduce pain and improve functioning in individuals with fibromyalgia.Forty-five women with fibromyalgia were randomized to a manualized ASA intervention (n = 24) or wait-list control (n = 21). The intervention began with a one-time physician consultation, followed by 3 weekly, 2-h group sessions based upon a mind-body model of pain. Sessions focused on structured written emotional disclosure and emotional awareness exercises. Outcomes in both conditions were measured by a blinded assessor at baseline, post-intervention, and 6-month follow-up.The primary outcome was pain severity (Brief Pain Inventory); secondary outcomes included tender-point threshold and physical function (SF-36 Physical Component Summary). Intent-to-treat analyses compared groups on outcomes using analysis of covariance and on the proportion of patients achieving ? 30% and ? 50% pain reduction at 6 months.Adjusting for baseline scores, the intervention group had significantly lower pain severity (p < 0.001), higher self-reported physical function (p < 0.001), and higher tender-point threshold (p = 0.02) at 6 months compared to the control group. From baseline to 6 months, 45.8% of the ASA intervention group had ? 30% reduction in pain severity, compared to none of the controls (p < 0.001).The affective self-awareness intervention improved pain, tenderness, and self-reported physical function for at least 6 months in women with fibromyalgia compared to wait-list control. This study suggests the value of interventions targeting emotional processes in fibromyalgia, although further studies should evaluate the efficacy of this intervention relative to active controls.
| S-EPMC2955480 | biostudies-literature
Project description:OBJECTIVE:Thoracic radiotherapy (TRT) may result in toxicities that are associated with performance declines and poor quality of life (QOL) for patients and their family caregivers. The purpose of this randomized controlled trial was to establish feasibility and preliminary efficacy of a dyadic yoga (DY) intervention as a supportive care strategy. METHODS:Patients with stage I to III non-small cell lung or esophageal cancer undergoing TRT and their caregivers (N = 26 dyads) were randomized to a 15-session DY or a waitlist control (WLC) group. Prior to TRT and randomization, both groups completed measures of QOL (SF-36) and depressive symptoms (CES-D). Patients also completed the 6-minute walk test (6MWT). Dyads were reassessed on the last day of TRT and 3 months later. RESULTS:A priori feasibility criteria were met regarding consent (68%), adherence (80%), and retention (81%) rates. Controlling for relevant covariates, multilevel modeling analyses revealed significant clinical improvements for patients in the DY group compared with the WLC group for the 6MWT (means: DY = 473 m vs WLC = 397 m, d = 1.19) and SF-36 physical function (means: DY = 38.77 vs WLC = 30.88; d = .66) and social function (means: DY = 45.24 vs WLC = 39.09; d = .44) across the follow-up period. Caregivers in the DY group reported marginally clinically significant improvements in SF-36 vitality (means: DY = 53.05 vs WLC = 48.84; d = .39) and role performance (means: DY = 52.78 vs WLC = 48.59; d = .51) relative to those in the WLC group. CONCLUSIONS:This novel supportive care program appears to be feasible and beneficial for patients undergoing TRT and their caregivers. A larger efficacy trial with a more stringent control group is warranted.
| S-EPMC6405285 | biostudies-literature
Project description:This study compared a behavioral weight loss program (BWL) with a stress management-based program, Emotional Brain Training (EBT), on weight loss, blood pressure, depression, perceived stress, diet, and physical activity.Subjects with a body mass index (BMI) of >28 and <45 kg/m(2) were recruited in Lexington, Kentucky in January 2014 and randomized to BWL or EBT for a 20-week intervention. Of those recruited, 49 participants were randomized to EBT or BWL. Randomization and allocation to group were performed using SPSS software. Weight, blood pressure, depression, perceived stress, dietary intake, and physical activity were measured at baseline, 10 week, and 20 week. Linear models for change over time were fit to calculate 95% confidence intervals of intervention effects.BWL produced greater changes in BMI than EBT at both 10 (P = 0.02) and 20 wk (P = 0.03). At 10 wk, both EBT and BWL improved BMI, systolic blood pressure, depression and perceived stress (P < 0.05). BWL also improved diastolic blood pressure (P = 0.005). At 20 wk, EBT maintained improvements in BMI, systolic blood pressure, depression, and perceived stress while BWL maintained improvements only in BMI and depression (P < 0.05).BWL produced greater weight loss than EBT; however, EBT produced sustained improvements in stress, depression, and systolic blood pressure. A combination of the two approaches should be explored.
| S-EPMC4877253 | biostudies-literature
Project description:Osteoarthritis (OA) is a common problem in older women that is associated with pain and disabilities. Although yoga is recommended as an exercise intervention to manage arthritis, there is limited evidence documenting its effectiveness, with little known about its long term benefits. This study's aims were to assess the feasibility and potential efficacy of a Hatha yoga exercise program in managing OA-related symptoms in older women with knee OA.Eligible participants (N=36; mean age 72 years) were randomly assigned to 8-week yoga program involving group and home-based sessions or wait-list control. The yoga intervention program was developed by a group of yoga experts (N=5). The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score that measures knee OA pain, stiffness, and function at 8 weeks. The secondary outcomes, physical function of the lower extremities, body mass index (BMI), quality of sleep (QOS), and quality of life (QOL), were measured using weight, height, the short physical performance battery (SPPB), the Pittsburgh Sleep Quality Index (PSQI), the Cantril Self-Anchoring Ladder, and the SF12v2 Health Survey. Data were collected at baseline, 4 weeks and 8 weeks, and 20 weeks.The recruitment target was met, with study retention at 95%. Based on ANCOVAs, participants in the treatment group exhibited significantly greater improvement in WOMAC pain (adjusted means [SE]) (8.3 [.67], 5.8 [.67]; p=.01), stiffness (4.7 [.28], 3.4 [.28]; p=.002) and SPPB (repeated chair stands) (2.0 [.23], 2.8 [.23]; p=.03) at 8 weeks. Significant treatment and time effects were seen in WOMAC pain (7.0 [.46], 5.4 [.54]; p=.03), function (24.5 [1.8], 19.9 [1.6]; p=.01) and total scores (35.4 [2.3], 28.6 [2.1]; p=.01) from 4 to 20 weeks. Sleep disturbance was improved but the PSQI total score declined significantly at 20 weeks. Changes in BMI and QOL were not significant. No yoga related adverse events were observed.A weekly yoga program with home practice is feasible, acceptable, and safe for older women with knee OA, and shows therapeutic benefits.ClinicalTrials.gov: NCT01832155.
| S-EPMC4038088 | biostudies-literature
Project description:To determine the feasibility of implementing a yoga intervention for cancer survivors with chronic CIPN pain, as well as the impact of the intervention on patient-reported outcomes. Cancer survivors with chronic CIPN pain were recruited from the breast, gastrointestinal, and gynecological oncology centers at Dana-Farber Cancer Institute. Participants were randomized (2:1) to receive an 8-week yoga intervention or usual care. After 21/50 of participants were enrolled, the COVID-19 pandemic required the yoga intervention to be delivered virtually (i.e., Zoom). Pre- and post-intervention, participants self-reported CIPN and co-occurring symptom severity. Adherence to the intervention was defined as practicing ≥ 12 yoga sessions over the 8-week intervention period. Changes in patient-reported outcomes between groups were compared using Wilcoxon's rank-sum tests. Participants (n = 28 yoga, n = 16 control) were mainly female (96%) and diagnosed with stage III/IV disease (66%). Overall, 19/28 (67.8%) of yoga group participants were adherent to the yoga protocol. Yoga group participants experienced significant within-group improvements in all patient-reported outcomes, including worst CIPN pain (median change = - 1.7, p < 0.0001) and sensory CIPN (median change = - 14.8, p < 0.0001), but only improvements in fatigue (p = 0.05) and depression (p = 0.04) were significant compared to the control. There were no differences (p > 0.05) in changes in patient-reported outcomes between in-person (n = 6) or virtual (n = 15) yoga group participants. Yoga is a feasible non-pharmacological modality for cancer survivors with CIPN, but more information is needed regarding its impact on CIPN and other symptoms. ClinicalTrials.gov Identifier: NCT03824860 IMPLICATIONS FOR CANCER SURVIVORS: Oncology clinicians may consider referring cancer survivors to yoga for chronic CIPN pain, but yoga cannot be currently recommended as an efficacious treatment.
| S-EPMC8442518 | biostudies-literature
Project description:We studied the effects of a specific cardio training program lasting 5 years on pain and quality of life in fibromyalgia patients.MethodAn observational longitudinal pilot study was conducted in 138 fibromyalgia women. Fibromyalgia women recruited were asked to carry out three sessions per week, each lasting 45 min, of moderate-intensity continuous training (64%-75% Maximal Heart rate [HRmax]). During the first year, the patients progressively increased their training intensity. During the last 2 years, the patients were asked to associate moderate-intensity continuous training and high-intensity interval training (85%-90% HRmax). Pain on a visual analog scale, anxiety and depression state on the Hospital Anxiety and Depression Scale, impact of fibromyalgia on daily life using the Fibromyalgia Impact Questionnaire, heart rate and sleep quality (visual analog scale) were assessed at baseline and each year for 5 years.ResultsForty-nine patients dropped out in the first year. Depending on their training status, the remaining 89 patients were retrospectively assigned to one of the three groups: Active (moderate-intensity continuous training), Semi-Active (one or two sessions, low-intensity continuous training <60% HRmax) and Passive (non-completion of training), based on their ability to comply with the program. Alleviation of all symptoms (p < 0.0001) was observed in the Active group. Increasing exercise intensity enhanced the effects obtained with moderate-intensity continuous training. Significant change in the Fibromyalgia Impact Questionnaire (p < 0.0001) and depression (Hospital Anxiety and Depression Scale; p < 0.0001), and no significant decrease in pain were noted in the Semi-Active group. No effect of the training was observed in the Passive group.ConclusionThe study intervention associated with multidisciplinary care alleviated pain, anxiety and depression, and improved both quality of life and quality of sleep, in fibromyalgia patients.
| S-EPMC7564648 | biostudies-literature
Project description:The lack of highly effective treatments for fibromyalgia (FM) represents a great challenge for public health. The objective of this parallel, pilot randomized controlled trial (RCT) was two-fold: (1) to analyze the clinical effects of mindfulness plus amygdala and insula retraining (MAIR) compared to a structurally equivalent active control group of relaxation therapy (RT) in the treatment of FM; and (2) to evaluate its impact on immune-inflammatory markers and brain-derived neurotrophic factor (BDNF) in serum. A total of 41 FM patients were randomized into two study arms: MAIR (intervention group) and RT (active control group), both as add-ons of treatment as usual. MAIR demonstrated significantly greater reductions in functional impairment, anxiety, and depression, as well as higher improvements in mindfulness, and self-compassion at post-treatment and follow-up, with moderate to large effect sizes. Significant decreases in pain catastrophizing and psychological inflexibility and improvements in clinical severity and health-related quality of life were found at follow-up, but not at post-treatment, showing large effect sizes. The number needed to treat was three based on the criteria of ?50% Fibromyalgia Impact Questionnaire (FIQ) reduction post-treatment. Compared to RT, the MAIR showed significant decreases in BDNF. No effect of MAIR was observed in immune-inflammatory biomarkers (i.e., TNF-?, IL-6, IL-10, and hs-CRP). In conclusion, these results suggest that MAIR, as an adjuvant of treatment-as-usual (TAU), appears to be effective for the management of FM symptoms and for reducing BDNF levels in serum.
| S-EPMC7599726 | biostudies-literature
Project description:BackgroundType 2 diabetes is a major health problem in many countries including India. Yoga may be an effective type 2 diabetes prevention strategy in India, particularly given its cultural familiarity.MethodsThis was a parallel, randomized controlled pilot study to collect feasibility and preliminary efficacy data on yoga for diabetes risk factors among people at high risk of diabetes. Primary outcomes included: changes in BMI, waist circumference, fasting blood glucose, postprandial blood glucose, insulin, insulin resistance, blood pressure, and cholesterol. We also looked at measures of psychological well-being including changes in depression, anxiety, positive and negative affect and perceived stress. Forty-one participants with elevated fasting blood glucose in Bangalore, India were randomized to either yoga (n = 21) or a walking control (n = 20). Participants were asked to either attend yoga classes or complete monitored walking 3-6 days per week for eight weeks. Randomization and allocation was performed using computer-generated random numbers and group assignments delivered in sealed, opaque envelopes generated by off-site study staff. Data were analyzed based on intention to treat.ResultsThis study was feasible in terms of recruitment, retention and adherence. In addition, yoga participants had significantly greater reductions in weight, waist circumference and BMI versus control (weight -0.8 ± 2.1 vs. 1.4 ± 3.6, p = 0.02; waist circumference -4.2 ± 4.8 vs. 0.7 ± 4.2, p < 0.01; BMI -0.2 ± 0.8 vs. 0.6 ± 1.6, p = 0.05). There were no between group differences in fasting blood glucose, postprandial blood glucose, insulin resistance or any other factors related to diabetes risk or psychological well-being. There were significant reductions in systolic and diastolic blood pressure, total cholesterol, anxiety, depression, negative affect and perceived stress in both the yoga intervention and walking control over the course of the study.ConclusionAmong Indians with elevated fasting blood glucose, we found that participation in an 8-week yoga intervention was feasible and resulted in greater weight loss and reduction in waist circumference when compared to a walking control. Yoga offers a promising lifestyle intervention for decreasing weight-related type 2 diabetes risk factors and potentially increasing psychological well-being.Trial registrationClinicalTrials.gov Identified NCT00090506.
| S-EPMC4096416 | biostudies-literature