Project description:BackgroundExercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction.MethodsIn this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue.ResultsDuring 2014-2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: -1.1-4.3]) or 6 months (0.3 [95% CI: -2.6-3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5-16.3]) and 6 months (10.8 kg [95% CI: 1.2-20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3-3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: -0.6-13.3]). There were no serious adverse events.ConclusionsExercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue.Clinical trial registrationThe study was registered with ISRCTN (38480455) and is completed.
Project description:To examine the impact of a pre-bariatric surgery physical activity intervention (PAI), designed to increase bout-related (?10 min) moderate to vigorous PA (MVPA), on health-related quality of life (HRQoL).Analyses included 75 adult participants (86.7% female; BMI = 45.0 ± 6.5 kg m(-2)) who were randomly assigned to 6 weeks of PAI (n = 40) or standard pre-surgical care (SC; n = 35). PAI received 6 individual weekly counseling sessions to increase walking exercise. Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes, respectively.PAI increased bout-related MVPA from baseline to post-intervention (4.4 ± 5.5 to 21.0 ± 21.4 min day(-1)) versus no change (7.9 ± 16.6 to 7.6 ± 11.5 min day(-1)) for SC (P = 0.001). PAI reported greater improvements than SC on all SF-36 physical and mental scales (P < 0.05), except role-emotional. In PAI, better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases (P < 0.05), and greater bout-related MVPA increases were associated with greater post-intervention improvements on the physical function, bodily pain, and general health scales (P < 0.05).Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery candidates. Future studies should examine whether this effect improves surgical safety, weight loss outcomes, and postoperative HRQoL.
Project description:People with multiple myeloma (MM) are second only to people with lung cancer for the poorest reported health-related quality of life (HRQoL) of all cancer types. Whether exercise can improve HRQoL in MM, where bone pain and lesions are common, requires investigation. This trial aims to evaluate the efficacy of an exercise intervention compared with control on HRQoL in people with MM. Following baseline testing, people with MM (n = 60) will be randomized to an exercise (EX) or waitlist control (WT) group. EX will complete 12-weeks of supervised (24 sessions) and unsupervised (12 sessions) individualized, modular multimodal exercise training. From weeks 12-52, EX continue unsupervised training thrice weekly, with one optional supervised group-based session weekly from weeks 12-24. The WT will be asked to maintain their current activity levels for the first 12-weeks, before completing the same protocol as EX for the following 52 weeks. Primary (patient-reported HRQoL) and secondary (bone health and pain, fatigue, cardiorespiratory fitness, muscle strength, body composition, disease response, and blood biomarkers) outcomes will be assessed at baseline, 12-, 24- and 52-weeks. Adverse events, attendance, and adherence will be recorded and cost-effectiveness analysis performed. The findings will inform whether exercise should be included as part of standard myeloma care to improve the health of this unique population.
Project description:BackgroundFatigue is a disabling symptom of multiple sclerosis (MS) and reduces quality of life. The aim of this study was to investigate the effects of a multimodal intervention, including a modified Paleolithic diet, nutritional supplements, stretching, strengthening exercises with electrical stimulation of trunk and lower limb muscles, and stress management on perceived fatigue and quality of life of persons with progressive MS.MethodsTwenty subjects with progressive MS and average Expanded Disability Status Scale (EDSS) score of 6.2 (range: 3.5-8.0) participated in the 12-month phase of the study. Assessments were completed at baseline and at 3 months, 6 months, 9 months, and 12 months. Safety analyses were based on monthly side effects questionnaires and blood analyses at 1 month, 3 months, 6 months, 9 months, and 12 months.ResultsSubjects showed good adherence (assessed from subjects' daily logs) with this intervention and did not report any serious side effects. Fatigue Severity Scale (FSS) and Performance Scales-fatigue subscale scores decreased in 12 months (P<0.0005). Average FSS scores of eleven subjects showed clinically significant reduction (more than two points, high response) at 3 months, and this improvement was sustained until 12 months. Remaining subjects (n=9, low responders) either showed inconsistent or less than one point decrease in average FSS scores in the 12 months. Energy and general health scores of RAND 36-item Health Survey (Short Form-36) increased during the study (P<0.05). Decrease in FSS scores during the 12 months was associated with shorter disease duration (r=0.511, P=0.011), and lower baseline Patient Determined Disease Steps score (r s=0.563, P=0.005) and EDSS scores (r s=0.501, P=0.012). Compared to low responders, high responders had lower level of physical disability (P< 0.05) and lower intake of gluten, dairy products, and eggs (P=0.036) at baseline. High responders undertook longer duration of massage and stretches per muscle (P<0.05) in 12 months.ConclusionA multimodal intervention may reduce fatigue and improve quality of life of subjects with progressive MS. Larger randomized controlled trials with blinded raters are needed to prove efficacy of this intervention on MS-related fatigue.
Project description:This study evaluated a 12-week, home-based combined aerobic exercise (walking) and computerized cognitive training (EX/CCT) program on heart failure (HF) self-care behaviors (Self-care of HF Index [SCHFI]), disease specific quality of life (Kansas City Cardiomyopathy Questionnaire [KCCQ]), and functional capacity (6-minute walk distance) compared to exercise only (EX) or a usual care attention control (AC) stretching and flexibility program. Participants (N = 69) were older, predominately female (54%) and African American (55%). There was significant improvement in self-care management, F(2, 13) = 5.7, p < .016; KCCQ physical limitation subscale, F(2, 52) = 3.4, p < .039; and functional capacity (336 ± 18 vs 388 ± 20 m, p < .05) among the EX/CCT participants. The underlying mechanisms that EX and CCT targets and the optimal dose that leads to improved outcomes are needed to design effective interventions for this rapidly growing population.
Project description:IntroductionRecent reports indicate that mitochondrial quality decreases during non-alcoholic fatty liver disease (NAFLD) progression, and targeting the mitochondria may be a possible treatment for NAFLD. Exercise can effectively slow NAFLD progression or treat NAFLD. However, the effect of exercise on mitochondrial quality in NAFLD has not yet been established.MethodsIn the present study, we fed zebrafish a high-fat diet to model NAFLD, and subjected the zebrafish to swimming exercise.ResultsAfter 12 weeks, swimming exercise significantly reduced high-fat diet-induced liver injury, and reduced inflammation and fibrosis markers. Swimming exercise improved mitochondrial morphology and dynamics, inducing upregulation of optic atrophy 1(OPA1), dynamin related protein 1 (DRP1), and mitofusin 2 (MFN2) protein expression. Swimming exercise also activated mitochondrial biogenesis via the sirtuin 1 (SIRT1)/ AMP-activated protein kinase (AMPK)/ PPARgamma coactivator 1 alpha (PGC1α) pathway, and improved the mRNA expression of genes related to mitochondrial fatty acid oxidation and oxidative phosphorylation. Furthermore, we find that mitophagy was suppressed in NAFLD zebrafish liver with the decreased numbers of mitophagosomes, the inhibition of PTEN-induced kinase 1 (PINK1) - parkin RBR E3 ubiquitin protein ligase (PARKIN) pathway and upregulation of sequestosome 1 (P62) expression. Notably, swimming exercise partially recovered number of mitophagosomes, which was associated with upregulated PARKIN expression and decreased p62 expression.DiscussionThese results demonstrate that swimming exercise could alleviate the effects of NAFLD on the mitochondria, suggesting that exercise may be beneficial for treating NAFLD.
Project description:ObjectiveTo determine the impact of the Text Message Educational Automated Compliance Help (TEACH) text message intervention as a pragmatic approach for patient engagement among adolescents with celiac disease (CD) as measured by gluten-free diet (GFD) adherence, patient activation, and quality of life (QOL).Study designRandomized controlled trial with patient recruitment at a pediatric, university-based hospital and through social media; 61 participants ages 12-24 years with CD diagnosed at least 1 year were enrolled. The TEACH intervention cohort received 45 unique text messages over a 3-month study period while the control group received standard of care treatment. Primary outcome measures included objective markers of GFD adherence included serum tissue transglutaminase IgA and deamidated gliadin peptide IgA levels. Secondary patient-reported outcomes collected via online survey included the Celiac Dietary Adherence Test, National Institutes of Health (NIH) Patient-Reported Outcomes Measurement Information System (PROMIS) Global Short Form measure of QOL, Celiac Symptom Index, and Patient Activation Measure. All measures were assessed at enrollment and after the 3-month study period. Statistical analysis performed using the 2-tailed paired Student t test.ResultsAmong the TEACH intervention group, there was significant improvement comparing enrollment scores with 3-month follow-up scores in patient activation (Patient Activation Measure score 63.1 vs 72.5, P?=?.01) and QOL (NIH PROMIS Global Mental Health 50.8 vs 53.3, P?=?.01 and NIH PROMIS Global Physical Health 50.8 vs 57.7, P?=?.03). There was no statistically significant difference in patient-reported or objectively measured GFD adherence.ConclusionsTEACH is an effective intervention among patients with CD to improve patient activation and QOL, even among a cohort with GFD adherence at baseline.Trial registrationClinicalTrials.gov: NCT02458898.
Project description:Autologous stem cell transplantation (ASCT) is an integral part of the frontline therapy in eligible multiple myeloma (MM) patients. The impact of ASCT on health-related quality of life (HRQoL) in myeloma has not been well described. We performed a systematic literature search to identify studies evaluating the impact of ASCT on HRQoL. Our search retrieved 12 relevant studies: 10 manuscripts and 2 conference abstracts. There was a widespread heterogeneity across studies in instruments used to measure HRQoL, time points of measurement, and statistical analysis. Only 1 study was a randomized controlled trial with HRQoL as a prespecified secondary endpoint. The common theme that emerged from most studies is that ASCT leads to an immediate deterioration in HRQoL and increase in symptom burden. However, baseline HRQoL and symptom scores are regained as early as 1 to 2 months post-transplantation. Furthermore, an improvement in HRQoL and pain on long-term follow-up was noted in some studies. We describe opportunities for further research in this area, including routine incorporation of HRQoL as an endpoint in transplant-related clinical trials and need for trials investigating interventions that may improve short and long-term HRQoL in myeloma ASCT recipients.
Project description:BackgroundLifestyle intervention in type 2 diabetes mellitus (T2DM) is effective but needs a special local setting and is costly. Therefore, in a randomized-controlled trial we tested the hypothesis that the autonomous use of the interactive exercise game Wii Fit Plus over a period of 12 weeks improves metabolic control, with HbA1c reduction as the primary outcome, and weight loss, reduction of cardiometabolic risk factors, physical activity and quality of life (secondary outcomes) in T2DM patients.MethodsParticipants (n = 220) were randomized into an intervention and a control group. The intervention group was provided with a Wii console, a balance board and the exercise game Wii Fit Plus for 12 weeks. The control group remained under routine care and received the items 12 weeks later. At baseline and after 12 weeks (and for the control group additionally after 12 weeks of intervention) the participants' health parameters, medication, physical activity and validated questionnaires for quality of life (PAID, SF12, WHO-5, CES-D) were requested and compared in a complete case analysis using the Mann-Whitney test and the Wilcoxon signed rank test.Results80% of participants completed the 12-week study. Patients in the intervention group significantly improved HbA1c (from 7.1 ± 1.3% to 6.8 ± 0.9%; -0.3 ± 1.1%; p = 0.0002) in comparison to the control group (from 6.8 ± 0.9% to 6.7 ± 0.7%; -0.1 ± 0.5%) and also significantly reduced fasting blood glucose (from 135.8 ± 38.9 mg/dl to 126.6 ± 36.6 mg/dl; p = 0.04), weight (from 97.6 ± 19.2 kg to 96.3 ± 18.7 kg; p < 0.001) and body mass index (from 34.1 ± 6.5 kg/m2 to 33.5 ± 6.5 kg/m2; p < 0.001). Daily physical activity increased significantly (p < 0.001). Diabetes-dependent impairment, mental health, subjective wellbeing and quality of life also improved significantly, and the number of patients with depression decreased. Similar improvements were seen in the control group after exercise game intervention.ConclusionsIn this trial a low-threshold intervention with the interactive exercise game Wii Fit Plus was able to motivate T2DM patients to improve physical activity, glucometabolic control and quality of life.Trial registrationClinicalTrials.gov NCT01735643.