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Alternative Therapies in Health and... Sep 2023The selection of a control group should foremost be determined by the study's primary intended outcome and trial design. When examining the effects of the physical... (Randomized Controlled Trial)
Randomized Controlled Trial
CONTEXT
The selection of a control group should foremost be determined by the study's primary intended outcome and trial design. When examining the effects of the physical movements that comprise yoga postures, an active control group, with physical exercise as the control, is often recommended.
OBJECTIVE
The current study aimed to define an active control group that participates in physical exercise, emphasizing the importance of matching the exercise's volume to that of an intervention group's yoga, and to provide a tangible example from a federally funded, recently completed, randomized controlled trial.
DESIGN
The research team designed a control group, providing a case study as a example of it.
SETTING
The study took place at Colorado State University.
INTERVENTION
The exercise component for the control group included 60 minutes of low-intensity exercise, matched with 60 minutes of Hatha yoga for the intervention group. Because the intervention included chronic pain self-management in addition to the exercise component, the education component for the control group included 45 minutes of group-based, general health-and-wellness education and discussion.
CONCLUSIONS
Future randomized trials for yoga and other complementary or integrative health interventions should continue to use appropriate active control groups, which will serve to enhance the scientific rigor of conclusions that can be drawn with respect to the effectiveness of these interventions.
Topics: Humans; Yoga; Control Groups; Exercise; Physical Therapy Modalities
PubMed: 35687710
DOI: No ID Found -
Current Opinion in HIV and AIDS Nov 2023Ending the HIV epidemic will require the development of additional effective immune-mediated and nonimmune-mediated means of HIV prevention. Evaluating novel... (Review)
Review
PURPOSE OF REVIEW
Ending the HIV epidemic will require the development of additional effective immune-mediated and nonimmune-mediated means of HIV prevention. Evaluating novel interventions requires large, controlled trials demonstrating efficacy. Recent advances in the field of HIV prevention necessitate new approaches to efficacy trial design.
RECENT FINDINGS
Three classes of efficacy trial designs are possible: standard of prevention-controlled trials, active-controlled trials, and active-controlled trials augmented with external control data. Recent experience with these approaches provides lessons on considerations around and success of the designs. Additional experience and development is needed for the augmented active-controlled trial design.
SUMMARY
Efficacy trials of new HIV prevention interventions are feasible but require careful consideration, given the complexity and dynamic state of the prevention field. While standard of prevention-controlled efficacy trials are reasonable approaches for HIV vaccine and monoclonal antibody efficacy trials, trials of new antiretroviral agents may require active-controlled designs.
Topics: Humans; HIV Infections; Control Groups; Research Design; Anti-Retroviral Agents; AIDS Vaccines; Randomized Controlled Trials as Topic
PubMed: 37712852
DOI: 10.1097/COH.0000000000000818 -
Critical Reviews in Oncology/hematology Jun 2024Exercise before surgery, as part of prehabilitation, aiming to enhance patients' functional and physiological capacity, has become widespread, necessitating an in-depth... (Review)
Review
PURPOSE
Exercise before surgery, as part of prehabilitation, aiming to enhance patients' functional and physiological capacity, has become widespread, necessitating an in-depth understanding.
METHODS
A systematic search was conducted on Pubmed, Cochrane, and Scopus to examine the effect of exercise as prehabilitation, alone or in combination with other interventions, in patients with cancer. Interventional studies applying a single-arm, randomized controlled, or nonrandomized design were included.
RESULTS
A total of 96 studies were included, and categorized according to cancer types, i.e., gynecological, breast, urological, gastrointestinal and lung cancer. For each cancer site, the effect of exercise, on physical fitness parameters and postoperative outcomes, including length of hospital stay and postoperative complications, was reported.
CONCLUSION
Exercise as prehabilitation may have an important role in improving physical fitness, postoperative outcomes, and accelerating recovery, especially in certain types of malignancies.
Topics: Humans; Neoplasms; Preoperative Exercise; Exercise; Exercise Therapy; Postoperative Complications; Physical Fitness
PubMed: 38642726
DOI: 10.1016/j.critrevonc.2024.104350 -
Bioscience, Biotechnology, and... Oct 2023Although regular exercise has been reported to prevent depression, it has not been clarified whether the gut microbiota is involved in the factors that prevent...
Although regular exercise has been reported to prevent depression, it has not been clarified whether the gut microbiota is involved in the factors that prevent depression through exercise. We investigated the effects of voluntary exercise on the gut microbiota and the prevention of depression-like behaviors using mice. C57BL/6 J male mice were subjected to 10 weeks of sedentary control or wheel running, then they were subjected to social defeat stress (SDS). Exercise attenuated that sucrose drinking was decreased by SDS treatment. Exercise increased the expression of Bdnf and decreased expression of Zo-1 and Claudin5 in the brain. Fecal Turicibacter, Allobaculum, and Clostridium sensu stricto, and propionate in the cecum were decreased by the exercise. Voluntary exercise-induced antidepressant properties might be partially caused by suppression of serotonin uptake into gut microbiota and increase the permeability of the blood-brain barrier via reduced propionate production.
Topics: Male; Mice; Animals; Motor Activity; Gastrointestinal Microbiome; Propionates; Mice, Inbred C57BL; Antidepressive Agents; Depression; Stress, Psychological
PubMed: 37667506
DOI: 10.1093/bbb/zbad115 -
Nutrients Jul 2023An adequate nutritional intake is recommended for the prevention of physical frailty and sarcopenia. In particular, medium-chain fatty acids (MCFAs) are reportedly... (Randomized Controlled Trial)
Randomized Controlled Trial
A Randomized, Double-Blind, Controlled Trial Assessing If Medium-Chain Triglycerides in Combination with Moderate-Intensity Exercise Increase Muscle Strength in Healthy Middle-Aged and Older Adults.
An adequate nutritional intake is recommended for the prevention of physical frailty and sarcopenia. In particular, medium-chain fatty acids (MCFAs) are reportedly important for muscle strength in nursing home residents. However, the effects of MCFAs on healthy adults at risk for frailty remain unknown. Hence, a randomized, placebo-controlled study was conducted to investigate the effects of 12 weeks of medium-chain triglycerides (MCTs) intake and walking on muscle mass and function in healthy, sedentary, middle-aged and older adults with a low body mass index. Three MCT intake groups with different amounts of octanoic and decanoic acid intake were compared with a control group. After 12 weeks, knee extension strength increased in all groups, with the increases in all MCT intake groups being significantly higher than those in the control group ( < 0.05). Grip strength significantly increased from baseline in the MCT 6 g/day intake group ( < 0.05). The combination of aerobic exercise and MCT intake may be effective in preventing decline in muscle strength and promoting increase in muscle strength as they can improve muscle energy production, thereby contributing to the maintenance of good health for middle-aged and older adults at high risk for frailty and sarcopenia.
Topics: Middle Aged; Humans; Aged; Sarcopenia; Frailty; Dietary Supplements; Muscle Strength; Hand Strength; Exercise; Triglycerides; Muscle, Skeletal; Double-Blind Method
PubMed: 37513691
DOI: 10.3390/nu15143275 -
Journal of the American Medical... Feb 2024To investigate the effect of an exercise program on falls in intermediate and high-level long-term care (LTC) residents and to determine whether adherence, physical... (Randomized Controlled Trial)
Randomized Controlled Trial
OBJECTIVES
To investigate the effect of an exercise program on falls in intermediate and high-level long-term care (LTC) residents and to determine whether adherence, physical capacity, and cognition modified outcomes.
DESIGN
Randomized controlled trial.
SETTING AND PARTICIPANTS
Residents (n = 520, aged 84 ± 8 years) from 25 LTC facilities in New Zealand.
METHODS
Individually randomized to Staying UpRight, a physical therapist-led, balance and strength group exercise program delivered for 1 hour, twice weekly over 12 months. The control arm was dose-matched and used seated activities with no resistance. Falls were collected using routinely collected incident reports.
RESULTS
Baseline fall rates were 4.1 and 3.3 falls per person-year (ppy) for intervention and control groups. Fall rates over the trial period were 4.1 and 4.3 falls ppy respectively [P = .89, incidence rate ratio (IRR) 0.98, 95% CI 0.76, 1.27]. Over the 12-month trial period, 74% fell, with 63% of intervention and 61% of the control group falling more than once. Risk of falls (P = .56, hazard ratio 1.08, 95% CI 0.85, 1.36) and repeat falling or fallers sustaining an injury at trial completion were similar between groups. Fall rates per 100 hours walked did not differ between groups (P = .42, IRR 1.15, 95% CI 0.81, 1.63). Program delivery was suspended several times because of COVID-19, reducing average attendance to 26 hours over 12 months. Subgroup analyses of falls outcomes for those with the highest attendance (≥50% of classes), better physical capacity (Short Physical Performance Battery scores ≥8/12), or cognition (Montreal Cognitive Assessment scores ≥ 18/30) showed no significant impact of the program.
CONCLUSIONS/IMPLICATIONS
In intermediate and high-level care residents, the Staying UpRight program did not reduce fall rates or risk compared with a control activity, independent of age, sex, or care level. Inadequate exercise dose because of COVID-19-related interruptions to intervention delivery likely contributed to the null result.
Topics: Aged; Humans; Accidental Falls; COVID-19; Exercise; Exercise Therapy; Long-Term Care; Aged, 80 and over
PubMed: 38042173
DOI: 10.1016/j.jamda.2023.10.022 -
Journal of Affective Disorders Nov 2023The rapid pace of life nowadays has seen a gradual increase in public involvement in weekend warrior (WW), a physical activity (PA) pattern that allows people to...
Whether weekend warrior activity and other leisure-time physical activity pattern reduce the risk of depression symptom in the representative adults? A population-based analysis of NHANES 2007-2020.
BACKGROUND
The rapid pace of life nowadays has seen a gradual increase in public involvement in weekend warrior (WW), a physical activity (PA) pattern that allows people to exercise once or twice a week, the recommended moderate-to-vigorous PA per week, since regular PA takes much time. We aim at exploring the effect of WW activity and other PA patterns on depression symptoms in U.S adults.
METHODS
The level of PA was measured by self-reporting activity patterns, (inactive, insufficiently active, WW and regularly active). Participants with Patient Health Questionnaire-9 (PHQ-9) scores above 10 are considered to have depression symptoms.
RESULTS
A weighted sample of 23,258 participants representing 1049.8 million non-institutionalized U.S adults aged from 20 to 80. Compared with the inactive group, general adults who met the PA guidelines with PA once or twice per week [WW, adjusted odds ratio (AOR) = 0.790, 95%CI: 0.638, 0.987] or more frequent PA [Regularly active, (AOR = 0.761, 95%CI: 0.671, 0.864)], were inversely associated with depression symptoms, while the association has not been observed in adults with insufficiently active PA (AOR = 0.892, 95%CI: 0.783, 1.017). Increase in minutes, sessions and intensity of PA in regularly active and WW groups brought additional benefits for depression symptoms.
CONCLUSION
WW and other equivalent PA intensities patterns may be sufficient to reduce the risk of depression symptom. With the same recommended levels of PA, whether spread over the week or done in fewer days, adults may achieve the same benefits.
Topics: Humans; Adult; Nutrition Surveys; Depression; Motor Activity; Exercise; Leisure Activities
PubMed: 37543116
DOI: 10.1016/j.jad.2023.07.113 -
Anaesthesia Sep 2023The feasibility, safety and efficacy of prehabilitation in adult patients awaiting elective cardiac surgery are unknown. A total of 180 participants undergoing elective... (Randomized Controlled Trial)
Randomized Controlled Trial
The feasibility, safety and efficacy of prehabilitation in adult patients awaiting elective cardiac surgery are unknown. A total of 180 participants undergoing elective cardiac surgery were allocated randomly to receive either standard pre-operative care or prehabilitation, consisting of pre-operative exercise and inspiratory muscle training. The primary outcome was change in six-minute walk test distance from baseline to pre-operative assessment. Secondary outcomes included change in inspiratory muscle strength (maximal inspiratory pressure); sarcopenia (handgrip strength); quality of life and compliance. Safety outcomes were pre-specified surgical and pulmonary complications and adverse events. All outcomes were assessed at baseline; at pre-operative assessment; and 6 and 12 weeks following surgery. Mean (SD) age was 64.7 (10.2) years; 33/180 (18%) were women. In total, 65/91 (71.4%) participants who were allocated to prehabilitation attended at least four of eight supervised in-hospital exercise classes; participants aged > 50 years were more likely than younger participants to attend (odds ratio (95%CI) of 4.6 (1.0-25.1)). Six-minute walk test was not significantly different between groups (mean difference (95%CI) -7.8 m (-30.6-15.0), p = 0.503) in the intention-to-treat analysis. Subgroup analyses based on tests for interaction indicated improvements in six-minute walk test distance were larger amongst sarcopenic patients in the prehabilitation group (p = 0.004). Change in maximal inspiratory pressure from baseline to all time-points was significantly greater in the prehabilitation group, with the greatest mean difference (95%CI) observed 12 weeks after surgery (10.6 cmH O (4.6-16.6) cmH O, p < 0.001). There were no differences in handgrip strength or quality of life up to 12 weeks after surgery. There was no significant difference in postoperative mortality (one death in each group), surgical or pulmonary complications. Of 71 pre-operative adverse events, six (8.5%) were related to prehabilitation. The combination of exercise and inspiratory muscle training in a prehabilitation intervention before cardiac surgery was not superior to standard care in improving functional exercise capacity measured by six-minute walk test distance pre-operatively. Future trials should target patients living with sarcopenia and include inspiratory muscle strength training.
Topics: Adult; Humans; Female; Male; Preoperative Exercise; Quality of Life; Sarcopenia; Hand Strength; Exercise; Postoperative Complications
PubMed: 37402352
DOI: 10.1111/anae.16072 -
Bioscience Trends Sep 2023With the intensification of population aging worldwide, the health problems of the elderly have become a particular concern. Functional disability is a prominent problem... (Review)
Review
With the intensification of population aging worldwide, the health problems of the elderly have become a particular concern. Functional disability is a prominent problem in the aging of this population, resulting in the decreased quality of life of senile people. Risk factors for functional disability in the elderly include geriatric syndromes and the associated diseases such as frailty. The influence of frailty on the health of the elderly has been a hot topic in recent years. As a dynamic and reversible geriatric syndrome, it has become one of the important public health problems emerging around the world. Frailty lies between self-reliance and the need for care and is reversible. Reasonable preventive interventions can restore the elderly to an independent life. If no interventions are implemented, the elderly will face a dilemma. There is no gold standard for frailty screening around the world. In order to alleviate frailty in the elderly, many countries have conducted early screening for frailty, mainly focusing on nutrition, physical activity, and social participation, in order to detect and prevent frailty earlier and to reduce the incidence of frailty. This topic provides an overview of the current status of frailty, early screening for frailty, and the interventions for frailty in most countries of the world.
Topics: Aged; Humans; Aging; Exercise; Frailty; Healthy Aging; Quality of Life
PubMed: 37612123
DOI: 10.5582/bst.2023.01204 -
JAMA Network Open Nov 2023Mobile mental health applications (apps) for moderate to severe depression are proliferating, likely owing to their capacity to overcome the limitations of conventional... (Meta-Analysis)
Meta-Analysis
IMPORTANCE
Mobile mental health applications (apps) for moderate to severe depression are proliferating, likely owing to their capacity to overcome the limitations of conventional psychotherapy, but research on the potential moderators of treatment efficacy is lacking.
OBJECTIVE
To examine the treatment efficacy associated with mobile app interventions for moderate to severe depression and identify the potential moderators associated with better treatment outcomes.
DATA SOURCES
PubMed, Embase, and PsycINFO were searched from their inception to January 22, 2023.
STUDY SELECTION
Only randomized clinical trials evaluating mobile app treatments in adults with moderate to severe depression that published their results in English were included in the analysis.
DATA EXTRACTION AND SYNTHESIS
Three independent researchers extracted and assessed relevant studies, their risk of bias, the characteristics of the population and study design, and the components of the intervention program following the Preferred Reporting Items for Systematic Reviews and Meta-analyses reporting guidelines. A fixed-effects model was used for data analysis, and exploratory post hoc meta-regression and subgroup analyses were also conducted. Data were analyzed from February 16 to March 25, 2023.
MAIN OUTCOMES AND MEASURES
The main outcome was changes in depression symptom severity from before to after treatment, measured by standardized depression assessment instruments. Secondary outcomes included study-, intervention-, and patient-level factors associated with app efficacy.
RESULTS
Of 2128 studies identified, 13 studies evaluating 16 intervention apps with 1470 participants with moderate to severe depression were included in the analysis. The overall pooled effect size of mobile app interventions vs both active and inactive control groups was 0.50 (95% CI, 0.40 to 0.61). Interventions with in-app notifications were associated with significantly lower treatment outcomes (standardized mean difference [SMD], 0.45; 95% CI, 0.29-0.60) than interventions without (SMD, 0.71; 95% CI, 0.54-0.87; P = .02). In addition, app interventions delivered for less than 8 weeks were associated with a significantly greater effect size (SMD, 0.77; 95% CI, 0.59-0.96) than interventions delivered for 8 weeks or longer (SMD, 0.43; 95% CI, 0.30-0.57; P = .004).
CONCLUSIONS AND RELEVANCE
In this systematic review and meta-analysis, the feasibility and efficacy of mobile app interventions were supported in treating moderate and severe depression, and practical implications were also provided for developing effective app-based interventions in clinical practice.
Topics: Adult; Humans; Depression; Depressive Disorder, Major; Mobile Applications; Behavior Therapy; Control Groups
PubMed: 37983028
DOI: 10.1001/jamanetworkopen.2023.44120