The long-term effect of an exercise and diet intervention in asthma patients: a 1-year follow-up on a randomised controlled trial

BackgroundIn the EFFORT (Effects of Exercise and Diet in Nonobese Asthma Patients – A Randomized Controlled Trial) study, maximum exercise capacity (V′O2max) increased significantly within a 2-month high-intensity spinning period. Furthermore, the study concluded that only the combined exercise and diet intervention improved asthma control, significantly. This study examined whether original improvements in V′O2max and asthma control were present 1 year after intervention completion.MethodIn the original trial, 149 patients were randomised into four study groups. Participants were assessed with an incremental cycle ergometer test and the Asthma Control Questionnaire (ACQ). Of the 149 patients, 66 accepted the follow-up invitation. Participants were distributed in their original groups: exercise group (n=18), diet group (n=117), combined diet and exercise group (n=115) and the control group (n=110). Patients were assessed with original procedures. Though, upon measuring V′O2max, the original four study groups were merged into one spinning group (n=127) and one nonspinning group (n=133).ResultsComparing the spinning and nonspinning group, there was no significant between-group difference in V′O2max, at 1-year follow-up (p=0.3). In addition, there was no significant between-group difference in ACQ score (p=0.6). Hence, in the combined group, the initial improvement in the ACQ score had regressed to pre-intervention values within 1 year from study completion.ConclusionThere were no measurable long-lasting effects on V′O2max 1 year after the intervention was completed. Furthermore, there was no long-lasting effect of the combined intervention on asthma control.

Download Full-text

A pilot randomized controlled trial of exercise to improve cognitive performance in patients with stable glioma: a proof of concept

Neuro-Oncology ◽

10.1093/neuonc/noz178 ◽

2019 ◽

Vol 22 (1) ◽

pp. 103-115 ◽

Cited By ~ 1

Author(s):

Karin Gehring ◽

Martijn M Stuiver ◽

Eva Visser ◽

Corelien Kloek ◽

Martin van den Bent ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cognitive Performance ◽

Cognitive Deficits ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Proof Of Concept ◽

Randomized Controlled ◽

Pilot Randomized Controlled Trial

Abstract Background Patients with glioma often suffer from cognitive deficits. Physical exercise has been effective in ameliorating cognitive deficits in older adults and neurological patients. This pilot randomized controlled trial (RCT) explored the possible impact of an exercise intervention, designed to improve cognitive functioning in glioma patients, regarding cognitive test performance and patient-reported outcomes (PROs). Methods Thirty-four clinically stable patients with World Health Organization grades II/III glioma were randomized to a home-based remotely coached exercise group or an active control group. Patients exercised 3 times per week for 20–45 minutes, with moderate to vigorous intensity, during 6 months. At baseline and immediate follow-up, cognitive performance and PROs were assessed with neuropsychological tests and questionnaires, respectively. Linear regression analyses were used to estimate effect sizes of potential between-group differences in cognitive performance and PROs at 6 months. Results The exercise group (n = 21) had small- to medium-sized better follow-up scores than the control group (n = 11) on several measures of attention and information processing speed, verbal memory, and executive function, whereas the control group showed a slightly better score on a measure of sustained selective attention. The exercise group also demonstrated small- to medium-sized better outcomes on measures of self-reported cognitive symptoms, fatigue, sleep, mood, and mental health–related quality of life. Conclusions This small exploratory RCT in glioma patients provides a proof of concept with respect to improvement of cognitive functioning and PROs after aerobic exercise, and warrants larger exercise trials in brain tumor patients.

Download Full-text

Exercise improves long-term social and behavioral rhythms in older adults: Did it play a role during the COVID-19 lockdown?

Journal of Public Health Research ◽

10.4081/jphr.2021.2432 ◽

2021 ◽

Author(s):

Giulia Cossu ◽

Cesar Ivan Abbile Gonzalez ◽

Luigi Minerba ◽

Roberto Demontis ◽

Massimiliano Pau ◽

...

Keyword(s):

Older Adults ◽

Controlled Trial ◽

Exercise Program ◽

Exercise Group ◽

Moderate Intensity ◽

Control Group ◽

Moderate Intensity Exercise ◽

Behavioral Rhythms

The study aimed to verify whether exercise training in older adults can improve social behavioral rhythms (SBR) and if any modification is maintained over time. Older adults (n=120) from a previous randomized controlled trial, were randomly allocated to either a moderate-intensity exercise group or a control group. SBR was evaluated at t0, t26, and t48 weeks (during the COVID-19 lockdown), using the brief social rhythms scale (BSRS). Seventy-nine participants completed the follow-up (age 72.3±4.7, women 55.3%). An improvement in the BSRS score was found in the exercise group at 26 weeks (p=0.035) when the exercise program was concluded, and it was maintained at 48 weeks (p=0.013). No improvements were observed in the control group. To conclude, SBR, previously found as a resilience factor in older adults during COVID-19, appear to improve after a moderate 12 weeks exercise program, and the improvement persisted even after stopping exercise during the COVID-19 lockdown.

Download Full-text

Physical Exercise Improves Cognitive Function in Older Adults with Stage 3–4 Chronic Kidney Disease: A Randomized Controlled Trial

American Journal of Nephrology ◽

10.1159/000520230 ◽

2021 ◽

pp. 1-11

Author(s):

Yuhei Otobe ◽

Minoru Yamada ◽

Koji Hiraki ◽

Satoshi Onari ◽

Yasuhiro Taki ◽

...

Keyword(s):

Older Adults ◽

Chronic Kidney Disease ◽

Physical Exercise ◽

Controlled Trial ◽

Exercise Group ◽

Control Group ◽

Delayed Recall ◽

Randomized Controlled ◽

Exercise Effect

Introduction: Patients with chronic kidney disease (CKD) exhibit a higher probability of having cognitive impairment or dementia than those without CKD. The beneficial effects of physical exercise on cognitive function are known in the general older population, but more research is required in older adults with CKD. Methods: Eighty-one outpatients (aged ≥65 years) with CKD stage G3–G4 were assessed for eligibility. Among them, 60 were randomized (single-center, unblinded, and stratified) and 53 received the allocated intervention (exercise n = 27, control n = 26). Patients in the exercise group undertook group-exercise training at our facility once weekly and independent exercises at home twice weekly or more, for 24 weeks. Patients in the control group received general care. General and specific cognitive functions (memory, attention, executive, and verbal) were measured, and differences in their scores at baseline and at the 24-week follow-up visit were assessed between the 2 groups. Results: Forty-four patients completed the follow-up at 24 weeks (exercise n = 23, control n = 21). Patients in the exercise group showed significantly greater changes in Wechsler Memory Scale-Revised Logical Memory delayed recall (exercise effect: 2.82, 95% CI: 0.46–5.19, p = 0.03), and immediate and delayed recall (exercise effect: 5.97, 95% CI: 1.13–10.81, p = 0.02) scores than those in the control group. Conclusions: The 24-week exercise intervention significantly improved the memory function in older adults with pre-dialysis CKD. This randomized controlled trial suggests that physical exercise is a useful nonpharmacological strategy for preventing cognitive decline in these patients.

Download Full-text

Using Personalized Anchors to Establish Routine Meditation Practice with a Mobile App: Randomized Controlled Trial (Preprint)

10.2196/preprints.32794 ◽

2021 ◽

Author(s):

Chad Stecher ◽

Mariah Sullivan ◽

Jennifer Huberty

Keyword(s):

Randomized Controlled Trial ◽

Linear Trend ◽

Controlled Trial ◽

Health Benefits ◽

Study Groups ◽

Mobile App ◽

Control Group ◽

Daily Routine ◽

Randomized Controlled

BACKGROUND Physical and mental health benefits can be attained from persistent, long-term performance of mindfulness meditation with a mobile meditation app, but in general, few mobile health app users persistently engage at a level necessary to attain the corresponding health benefits. Anchoring, or pairing, meditation with a mobile app to an existing daily routine can establish an unconsciously initiated meditation routine that may improve meditation persistence. OBJECTIVE The purpose of this study was to test the use of either personalized anchors or fixed anchors for establishing a persistent meditation app routine with the mobile app Calm. METHODS A randomized controlled trial was implemented that randomly assigned participants to one of three study groups: a) Personalized Anchor (PA), b) Fixed Anchor (FA), or a c) control group that did not use the anchoring strategy. All participants received app-delivered reminder messages to meditate for at least 10 minutes a day for an eight-week intervention period, and app usage data continued to be collected for an eight-week follow-up period to measure meditation persistence. Baseline, week eight, and week 16 surveys were administered to assess demographics, socioeconomic status, and changes in self-reported habit strength. RESULTS A total of 101 participants across the three study groups were included in the final analysis: a) PA (N=56), b) FA (N=49), and c) control group (N=62). Participants were predominantly White (81%), female (76%), and college educated (i.e., bachelor’s or graduate degree; 81%). The FA group had a significantly higher odds of daily meditation at the start of the intervention (1.14 OR; 95% CI 1.02 – 1.33; P = 0.04), and all participants experienced a linear decline in their odds of daily meditation during the eight-week intervention (0.96 OR; 95% CI 0.95 – 0.96; P < 0.01). Importantly, only the FA group showed a significantly smaller decline in the linear trend of their odds of daily meditation during the eight-week follow-up (their daily trend increased by 1.04 OR; 95% CI 1.01 – 1.06; P = 0.03). Additionally, those who more frequently adhered to their anchoring strategy during the intervention showed a significantly smaller decline in the linear trend of their odds of daily meditation during the eight-week follow-up period (1.13 OR; 95% CI 1.02 – 1.35; P < 0.01). CONCLUSIONS The FA group had more persistent meditation with the app, but participants in either the FA or PA groups who more frequently adhered to their anchoring strategy during the intervention had the most persistent meditation routines, and almost all of these high-anchorers used morning anchors. These findings suggest that using the anchoring strategy can create persistent meditation routines with a mobile app. However, future studies should test additional intervention tools (i.e., reminders plus incentives) to help more participants successfully adhere to their anchored meditation routine.

Download Full-text

Randomized Controlled Trial Effect of Short-Term MIND Diet Intervention on Hunger Hormones, Anthropometric Parameters, and Brain Structures in Middle-Aged Obese Women

10.1101/2020.06.28.20142018 ◽

2020 ◽

Author(s):

Golnaz Arjmand ◽

Mojtaba Abbas-Zadeh ◽

Majid fardaei ◽

Mohammad Hassan Eftekhari

Keyword(s):

Controlled Trial ◽

Brain Structures ◽

Diet Group ◽

Control Group ◽

Obese Women ◽

Short Term ◽

Anthropometric Parameters ◽

The Mind ◽

Mind Diet

AbstractThe growing prevalence of obesity and its destructive effects on the hormone’s circulation and brain structures has attracted attention to specific dietary patterns. This trial aimed to examine the effect of short-term newly Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) pattern on anthropometric parameters, hunger hormones as well as brain structures in obese women. The study was a randomized restricted controlled trial in which we analyzed 37 healthy obese women with a mean age of 48 ± 5.38 years and mean Body Mass Index (BMI) 32 ± 4.31 kg/m2. Participants were randomly allocated to a hypocaloric modified MIND diet or a hypocaloric waiting list control diet and followed the protocols for three months. Differences in anthropometric and laboratory analysis, as well as brain structures, were determined at baseline and follow up. There was a more significant reduction in weight, BMI, percentage of body fat, waist circumference, and Leptin concentration in the MIND diet group compared to the control group (ps<0.05). Despite a deceased in plasma levels of Ghrelin and GLP-1 in the control group, results have found a significant increase in these hunger hormones in the MIND diet group (ps<0.05). Our results diminished to detect any differences in the whole and regional brain structures between two groups after three months follow up. Our trial for the first time demonstrated that a three-month MIND diet intervention could improve the potentially devastating effect of obesity on metabolic profiles and anthropometric parameters. However, we couldn’t find the MIND diet effect on brain structures.

Download Full-text

Increasing Life-Space Mobility in Community-Dwelling Older Persons With Cognitive Impairment Following Rehabilitation: A Randomized Controlled Trial

The Journals of Gerontology Series A ◽

10.1093/gerona/glaa254 ◽

2020 ◽

Author(s):

Phoebe Ullrich ◽

Christian Werner ◽

Martin Bongartz ◽

Tobias Eckert ◽

Bastian Abel ◽

...

Keyword(s):

Cognitive Impairment ◽

Older Persons ◽

Controlled Trial ◽

Intervention Group ◽

Community Dwelling ◽

Control Group ◽

Life Space ◽

Home Based ◽

Independent Life

Abstract Background Community-dwelling older persons with cognitive impairment (CI) following discharge from geriatric rehabilitation are at high risk of losing life-space mobility (LSM). Interventions to improve their LSM are, however, still lacking. The aim of this study was to evaluate the effects of a CI-specific, home-based physical training and activity promotion program on LSM. Methods Older persons with mild-to-moderate CI (Mini-Mental State Examination: 17–26 points) discharged home from rehabilitation were included in this double-blinded, randomized, placebo-controlled trial with a 12-week intervention period and 12-week follow-up period. The intervention group received a CI-specific, home-based strength, balance, and walking training supported by tailored motivational strategies. The control group received a placebo activity. LSM was evaluated by the Life-Space Assessment in Persons with Cognitive Impairment, including a composite score for LSM and 3 subscores for maximal, equipment-assisted, and independent life space. Mixed-model repeated-measures analyses were used. Results One hundred eighteen participants (82.3 ± 6.0 years) with CI (Mini-Mental State Examination: 23.3 ± 2.4) were randomized. After the intervention, the home-based training program resulted in a significant benefit in the Life-Space Assessment in Persons with Cognitive Impairment composite scores (b = 8.15; 95% confidence interval: 2.89–13.41; p = .003) and independent life-space subscores (b = 0.39; 95% confidence interval: 0.00–0.78; p = .048) in the intervention group (n = 63) compared to control group (n = 55). Other subscores and follow-up results were not significantly different. Conclusions The home-based training program improved LSM and independent life space significantly in this vulnerable population. Effects were not sustained over the follow-up. The program may represent a model for improved transition from rehabilitation to the community to prevent high risk of LSM restriction.

Download Full-text

Anti-adhesion Gel versus No gel following Operative Hysteroscopy prior to Subsequent fertility Treatment or timed InterCourse (AGNOHSTIC), a randomised controlled trial: protocol

Human Reproduction Open ◽

10.1093/hropen/hoab001 ◽

2021 ◽

Vol 2021 (1) ◽

Author(s):

S van Wessel ◽

T Hamerlynck ◽

V Schutyser ◽

C Tomassetti ◽

C Wyns ◽

...

Keyword(s):

Live Birth ◽

Financial Support ◽

Controlled Trial ◽

Reproductive Age ◽

Fertility Treatment ◽

Control Group ◽

Women Of Reproductive Age ◽

Operative Hysteroscopy ◽

Randomised Controlled

Abstract STUDY QUESTIONS Does the application of anti-adhesion gel, compared to no gel, following operative hysteroscopy to treat intrauterine pathology in women wishing to conceive increase the chance of conception leading to live birth? WHAT IS KNOWN ALREADY Intrauterine adhesions (IUAs) following operative hysteroscopy may impair reproductive success in women of reproductive age. Anti-adhesion barrier gels may decrease the occurrence of IUAs, but the evidence on their effectiveness to improve reproductive outcomes is sparse and of low quality. STUDY DESIGN, SIZE, DURATION This multicentre, parallel group, superiority, blinded and pragmatic randomised controlled trial is being carried out in seven participating centres in Belgium. Recruitment started in April 2019. Women will be randomly allocated to treatment with anti-adhesion gel (intervention group) or no gel (control group). Sterile ultrasound gel will be applied into the vagina as a mock-procedure in both treatment arms. The patient, fertility physician and gynaecologist performing the second-look hysteroscopy are unaware of the allocated treatment. Power analysis, based on a target improvement of 15% in conception leading to live birth using anti-adhesion gel, a power of 85%, a significance level of 5%, and a drop-out rate of 10%, yielded a number of 444 patients to be randomised. The baseline rate of conception leading to live birth in the control group is expected to be 45%. PARTICIPANTS/MATERIALS, SETTING, METHODS Women of reproductive age (18–47 years), wishing to conceive (spontaneously or by fertility treatment) and scheduled for operative hysteroscopy to treat intrauterine pathology (endometrial polyps, myomas with uterine cavity deformation, uterine septa, IUAs or retained products of conception) are eligible for recruitment. Women may try to conceive from 3 to 6 weeks after receiving allocated treatment with follow-up ending at 30 weeks after treatment. If the woman fails to conceive within this timeframe, a second-look hysteroscopy will be scheduled within 2–6 weeks to check for IUAs. The primary endpoint is conception leading to live birth, measured at 30 weeks after randomisation. The secondary endpoints are time to conception, clinical pregnancy, miscarriage and ectopic pregnancy rates, measured at 30 weeks after receiving allocated treatment. The long-term follow-up starts when the patient is pregnant and she will be contacted every trimester. STUDY FUNDING/COMPETING INTEREST(S) This work is funded by the Belgian Healthcare Knowledge Centre (KCE). The anti-adhesion gel is supplied at no cost by Nordic Pharma and without conditions. Dr. Tomassetti reports grants and non-financial support from Merck SA, non-financial support from Ferring SA, personal fees and non-financial support from Gedeon-Richter, outside the submitted work. None of the other authors have a conflict of interest.

Download Full-text

Moderate Consumption of Beer (with and without Ethanol) and Menopausal Symptoms: Results from a Parallel Clinical Trial in Postmenopausal Women

Nutrients ◽

10.3390/nu13072278 ◽

2021 ◽

Vol 13 (7) ◽

pp. 2278

Author(s):

Marta Trius-Soler ◽

María Marhuenda-Muñoz ◽

Emily P. Laveriano-Santos ◽

Miriam Martínez-Huélamo ◽

Gemma Sasot ◽

...

Keyword(s):

Postmenopausal Women ◽

Study Groups ◽

Menopausal Symptoms ◽

Control Group ◽

P Value ◽

Intervention Trial ◽

Hormone Profile ◽

Perimenopausal Symptoms ◽

Main Food Source

The menopausal transition can be a challenging period for women’s health and a trigger of uncomfortable symptoms. Beer is the main food source of isoxanthohumol, a precursor of 8-prenylnaringenin, the strongest phytoestrogen identified to date. As phytoestrogens are reported to reduce perimenopausal symptoms, we evaluated if a daily moderate consumption of beer with (AB) and without alcohol (NAB) could improve menopausal symptoms and modify cardiovascular risk factors. A total of 37 postmenopausal women were enrolled in a parallel controlled intervention trial and assigned to three study groups: 16 were administered AB (330 mL/day), 7 NAB (660 mL/day), and 14 were in the control group. After a 6-month follow-up of the 34 participants who finished the trial, both interventions (AB and NAB) significantly reduced the severity of the menopause-related symptoms (p-value AB vs. Control: 0.009; p-value NAB vs. Control: 0.033). Moreover, AB had a beneficial net effect on psychological menopausal discomforts compared to the control group. As the sex hormone profile did not differ significantly between the study groups, the effects of both types of beers (AB and NAB) are attributed to the non-alcoholic fraction of beer. Furthermore, moderate NAB consumption improved the lipid profile and decreased blood pressure in postmenopausal women.

Download Full-text

Nurse-based secondary preventive follow-up by telephone reduced recurrence of cardiovascular events: a randomised controlled trial

Scientific Reports ◽

10.1038/s41598-021-94892-0 ◽

2021 ◽

Vol 11 (1) ◽

Author(s):

Anna-Lotta Irewall ◽

Anders Ulvenstam ◽

Anna Graipe ◽

Joachim Ögren ◽

Thomas Mooe

Keyword(s):

Randomised Controlled Trial ◽

Primary Endpoint ◽

Cardiovascular Events ◽

Controlled Trial ◽

Control Group ◽

Coronary Syndrome ◽

Secondary Endpoints ◽

Randomised Controlled

AbstractEnhanced follow-up is needed to improve the results of secondary preventive care in patients with established cardiovascular disease. We examined the effect of long-term, nurse-based, secondary preventive follow-up by telephone on the recurrence of cardiovascular events. Open, randomised, controlled trial with two parallel groups. Between 1 January 2010 and 31 December 2014, consecutive patients (n = 1890) admitted to hospital due to stroke, transient ischaemic attack (TIA), or acute coronary syndrome (ACS) were included. Participants were randomised (1:1) to nurse-based telephone follow-up (intervention, n = 944) or usual care (control, n = 946) and followed until 31 December 2017. The primary endpoint was a composite of stroke, myocardial infarction, cardiac revascularisation, and cardiovascular death. The individual components of the primary endpoint, TIA, and all-cause mortality were analysed as secondary endpoints. The assessment of outcome events was blinded to study group assignment. After a mean follow-up of 4.5 years, 22.7% (n = 214) of patients in the intervention group and 27.1% (n = 256) in the control group reached the primary composite endpoint (HR 0.81, 95% CI 0.68–0.97; ARR 4.4%, 95% CI 0.5–8.3). Secondary endpoints did not differ significantly between groups. Nurse-based secondary preventive follow-up by telephone reduced the recurrence of cardiovascular events during long-term follow-up.

Download Full-text

A Short Mindfulness Retreat for Students to Reduce Stress and Promote Self-Compassion: Pilot Randomised Controlled Trial Exploring Both an Indoor and a Natural Outdoor Retreat Setting

Healthcare ◽

10.3390/healthcare9070910 ◽

2021 ◽

Vol 9 (7) ◽

pp. 910

Author(s):

Dorthe Djernis ◽

Mia S. O’Toole ◽

Lone O. Fjorback ◽

Helle Svenningsen ◽

Mimi Y. Mehlsen ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Effect Sizes ◽

Medium Effect ◽

Control Group ◽

Post Intervention ◽

Pilot Randomised Controlled Trial ◽

Self Compassion ◽

Randomised Controlled

Here, we developed and examined a new way of disseminating mindfulness in nature to people without meditation experience, based on the finding that mindfulness conducted in natural settings may have added benefits. We evaluated a 5-day residential programme aiming to reduce stress and improve mental health outcomes. We compared an indoor and an outdoor version of the programme to a control group in a pilot randomised controlled trial (RCT). Sixty Danish university students experiencing moderate to high levels of stress were randomised into a residential mindfulness programme indoors (n = 20), in nature (n = 22), or a control group (n = 18). Participants completed the Perceived Stress Scale and the Self-Compassion Scale (primary outcomes) along with additional secondary outcome measures at the start and end of the program and 3 months after. Stress was decreased with small to medium effect sizes post-intervention, although not statistically significant. Self-compassion increased post-intervention, but effect sizes were small and not significant. At follow-up, changes in stress were not significant, however self-compassion increased for both interventions with medium-sized effects. For the intervention groups, medium- to large-sized positive effects on trait mindfulness after a behavioural task were found post-intervention, and small- to medium-sized effects in self-reported mindfulness were seen at follow-up. Connectedness to Nature was the only outcome measure with an incremental effect in nature, exceeding the control with a medium-sized effect at follow-up. All participants in the nature arm completed the intervention, and so did 97% of the participants in all three arms. Overall, the results encourage the conduct of a larger-scale RCT, but only after adjusting some elements of the programme to better fit and take advantage of the potential benefits of the natural environment.

Download Full-text