Exercise during cancer treatment improves cancer‐related fatigue (CRF), but the importance of exercise intensity for CRF is unclear. We compared the effects of high‐ vs low‐to‐moderate‐intensity exercise with or without additional behavior change support (BCS) on CRF in patients undergoing (neo‐)adjuvant cancer treatment. This was a multicenter, 2x2 factorial design randomized controlled trial (Clinical Trials NCT02473003) in Sweden. Participants recently diagnosed with breast (n = 457), prostate (n = 97) or colorectal (n = 23) cancer undergoing (neo‐)adjuvant treatment were randomized to high intensity (n = 144), low‐to‐moderate intensity (n = 144), high intensity with BCS (n = 144) or low‐to‐moderate intensity with BCS (n = 145). The 6‐month exercise intervention included supervised resistance training and home‐based endurance training. CRF was assessed by Multidimensional Fatigue Inventory (MFI, five subscales score range 4‐20), and Functional Assessment of Chronic Illness Therapy‐Fatigue scale (FACIT‐F, score range 0‐52). Multiple linear regression for main factorial effects was performed according to intention‐to‐treat, with post‐intervention CRF as primary endpoint. Overall, 577 participants (mean age 58.7 years) were randomized. Participants randomized to high‐ vs low‐to‐moderate‐intensity exercise had lower physical fatigue (MFI Physical Fatigue subscale; mean difference −1.05 [95% CI: −1.85, −0.25]), but the difference was not clinically important (ie <2). We found no differences in other CRF dimensions and no effect of additional BCS. There were few minor adverse events. For CRF, patients undergoing (neo‐)adjuvant treatment for breast, prostate or colorectal cancer can safely exercise at high‐ or low‐to‐moderate intensity, according to their own preferences. Additional BCS does not provide extra benefit for CRF in supervised, well‐controlled exercise interventions.
BackgroundCancer-related fatigue is a common problem in persons with cancer, influencing health-related quality of life and causing a considerable challenge to society. Current evidence supports the beneficial effects of physical exercise in reducing fatigue, but the results across studies are not consistent, especially in terms of exercise intensity. It is also unclear whether use of behaviour change techniques can further increase exercise adherence and maintain physical activity behaviour. This study will investigate whether exercise intensity affects fatigue and health related quality of life in persons undergoing adjuvant cancer treatment. In addition, to examine effects of exercise intensity on mood disturbance, adherence to oncological treatment, adverse effects from treatment, activities of daily living after treatment completion and return to work, and behaviour change techniques effect on exercise adherence. We will also investigate whether exercise intensity influences inflammatory markers and cytokines, and whether gene expressions following training serve as mediators for the effects of exercise on fatigue and health related quality of life.Methods/designSix hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 × 2 factorial design to following conditions; A) individually tailored low-to-moderate intensity exercise with or without behaviour change techniques or B) individually tailored high intensity exercise with or without behaviour change techniques. The training consists of both resistance and endurance exercise sessions under the guidance of trained coaches. The primary outcomes, fatigue and health related quality of life, are measured by self-reports. Secondary outcomes include fitness, mood disturbance, adherence to the cancer treatment, adverse effects, return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines and gene expression.DiscussionThe study will contribute to our understanding of the value of exercise and exercise intensity in reducing fatigue and improving health related quality of life and, potentially, clinical outcomes. The value of behaviour change techniques in terms of adherence to and maintenance of physical exercise behaviour in persons with cancer will be evaluated.Trial registration NCT02473003, October, 2014.
BackgroundComparisons across studies of generalized joint hypermobility are often difficult since there are several classification methods and methodological differences in the performance exist. The Beighton score is most commonly used and has been tested for inter- and intra-rater reliability. The Contompasis score and the Hospital del Mar criteria have not yet been evaluated for reliability. The aim of this study was to investigate the inter- and intra-rater reliability for measurements of range of motion in joints included in these three hypermobility assessment methods using a structured protocol.MethodsThe study was planned in accordance with guidelines for reporting reliability studies. Healthy adults were consecutively recruited (49 for inter- and 29 for intra-rater assessments). Intra-class correlations, two-way random effects model, (ICC 2.1) with 95% confidence intervals, standard error of measurement, percentage of agreement, Cohen’s Kappa (κ) and prevalence-adjusted bias-adjusted kappa were calculated for single-joint measured in degrees and for total scores.ResultsThe inter- and intra-rater reliability in total scores were ICC 2.1: 0.72–0.82 and 0.76–0.86 and for single-joint measurements in degrees 0.44–0.91 and 0.44–0.90, respectively. The difference between ratings was within 5 degrees in all but one joint. Standard error of measurement ranged from 1.0 to 6.9 degrees. The inter- and intra-rater reliability for prevalence of positive hypermobility findings the Cohen’s κ for total scores were 0.54–0.78 and 0.27–0.78 and in single joints 0.21–1.00 and 0.19–1.00, respectively. The prevalence- and bias adjusted Cohen’s κ, increased all but two values.ConclusionsFollowing a structured protocol, the inter- and intra-rater reliability was good-to-excellent for total scores and in all but two single joints, measured in degrees. The inter- and intra-rater reliability for prevalence of positive hypermobility findings was fair-to-almost perfect for total scores and slight-to-almost-perfect in single joints.By using a structured protocol, we attempted to standardize the assessment of range of motion in clinical and in research settings. This standardization could be helpful in the first part of the process of standardizing the tests thus avoiding that assessment of GJH is based on chance.Electronic supplementary materialThe online version of this article (10.1186/s12891-018-2290-5) contains supplementary material, which is available to authorized users.
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