Effect of an Exercise Bout Prior to the Booster Dose of an Inactivated SARS-CoV-2 Vaccine on Immunogenicity in Immunocompromised Patients

Abstract This study aimed to investigate whether a single bout of exercise prior to the homologous booster dose of a SARS-CoV-2 inactivated vaccine (Sinovac-CoronaVac) could enhance immunogenicity in patients with dysfunctional immune system. This was a randomized controlled trial (1:1) within a single-arm, phase 4 vaccination trial, conducted in São Paulo, Brazil. Patients with spondyloarthritis assigned to the intervention group performed an exercise bout comprising three unilateral strength exercises involving eccentric and concentric contractions. After exercising, patients remained at rest for 1 h prior to vaccination, which was applied to the exercised arm. The control group remained at rest before vaccination. Immunogenicity was assessed before (Pre) and one month after (Post) the booster dose using seropositivity rates of total anti-SARS-CoV-2 S1/S2 IgG, geometric mean titers of anti-S1/S2 IgG (GMT), frequency of NAb positivity, and NAb activity. Before the booster dose, 16 patients from the exercise group and 16 patients from the control group exhibited seropositivity for IgG (59% vs. 57.1%), one month after the booster dose, seropositivity occurred in 96% vs. 100% of the cases (p = 0.84, group by time interaction). Only 10 patients from the exercise group and 12 patients from the control group showed positive NAb serology at Pre (37% vs. 42.8%). One month following the booster, NAb positivity was 96% vs. 93% (p = 0.41, group-by-time interaction). GMT was comparable between groups at Pre (p > 0.05). At Post, GMT increased similarly in both groups (exercise: 56.9%; control: 57.9%), with no group-by-time interaction (p = 0.82; estimated mean difference between groups at Post [EMD]: -40.4 UA/mL, 95%CI: -327, 246 UA/mL). Likewise, NAb activity was similar between groups at Pre and increased similarly in both of them as a result of the booster (47.5% vs. 39.9%), with no group-by-time interaction (p = 0.99; EMD: -6.19%, 95%CI: -17; 4.6%). In conclusion, a single bout of exercise did not enhance immunogenicity to a homologous booster dose of an inactivated SARS-CoV-2 vaccine among patients with spondyloarthritis. Studies assessing exercise as an adjuvant to first or second doses remain necessary.

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Cluster Randomized Controlled Trial of Disability Education Module During Clinical Clerkship

Clinical Pediatrics ◽

10.1177/0009922819850475 ◽

2019 ◽

Vol 58 (13) ◽

pp. 1387-1393

Author(s):

Jonathan D. Santoro ◽

Emily E. Whitgob ◽

Lynne C. Huffman

Keyword(s):

Group Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Family Control ◽

Time Interaction ◽

Functional Aspects ◽

Management Participation ◽

Cluster Randomized ◽

Disability Education

The effect of a randomized disability education program on medical student knowledge and attitudes concerning disability was performed. Intervention group received bedside teaching of physical examination/interview skills and case-based discussion. Twenty-three participants completed the study (control group n = 11; intervention group n = 12). Pre-clerkship, 39% of all participants reported no personal experience and 43% reported no professional experience with people with disabilities. Post-clerkship knowledge was higher for both groups; the test of group-by-time interaction was not significant. Qualitative analysis of post-clerkship attitude responses demonstrated that intervention group gave more detailed answers. Intervention group used terms representing functional aspects of disability twice as frequently as control group. Intervention group responses described long-term experience of a disability within community and family; control group responses focused on acute medical management. Participation in disability education resulted in changed attitude toward disability and better understanding of aspects of disability.

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The effectiveness of an online intervention in stimulating injury-preventive behaviour in adult novice runners. Results of a randomised controlled trial.

South African Journal of Sports Medicine ◽

10.17159/2078-516x/2021/v33i1a11297 ◽

2021 ◽

Vol 33 (1) ◽

pp. 1-9

Author(s):

Ellen Kemler ◽

Maaike Cornelissen ◽

Vincent Gouttebarge

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Online Intervention ◽

Control Group ◽

Warm Up ◽

Training Schedule ◽

Strength Exercises ◽

Preventive Behaviour ◽

Randomised Controlled

Background: The online intervention Runfitcheck was developed to stimulate injury-preventive behaviour among adult novice runners. Objective: The objective of this study was to evaluate the effectiveness of Runfitcheck on injury-preventive behaviour among adult novice runners. Material and methods: A randomised controlled trial was conducted among adult novice runners. The intervention group had access to the Runfitcheck intervention, the control group performed their running activities as usual. One, three, and five months after enrolment, participants reported retrospectively what they had done regarding injury-preventive behaviour (operationalised as (i) using a (personalised) training schedule; (ii) performing strength and technique exercises; and (iii) performing a warm-up routine prior to running). Relative Risks (RR) and 95% Confidence Interval (95%CI) were used to analyse behavioural change. Results: The intervention group (n=715) searched more often for information about a warm-up routine (RR 1.211; 95%CI 1.080-1.357), added more often strength exercises to their warm-up routine ( RR 1.228; 95%CI 1.092-1.380). The intervention group performed more often running technique exercises compared to the control group (n=696) (RR 1.134; 95%CI 1.015-1.267), but less often strength exercises (RR 0.865 (95%CI 0.752-0.995). Within the group of runners that did not perform any warm-up routine at enrolment (n=272), the intervention group performed a regular warm-up routine more often than the control group (RR 1.461; 95%CI 1.084-1.968) No significant results were found for using a training schedule. Discussion and conclusion: The online intervention Runfitcheck was effective in stimulating aspects of injury-preventive behaviour in adult novice runners, mostly related to a warm-up routine.

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The effectiveness of an online intervention in stimulating injury-preventive behaviour in adult novice runners. Results of a randomised controlled trial.

10.21203/rs.3.rs-22177/v1 ◽

2020 ◽

Author(s):

Ellen Kemler ◽

Maaike H. Cornelissen ◽

Vincent Gouttebarge

Keyword(s):

Randomised Controlled Trial ◽

Controlled Trial ◽

Intervention Group ◽

Online Intervention ◽

Control Group ◽

Warm Up ◽

Training Schedule ◽

Strength Exercises ◽

Preventive Behaviour ◽

Randomised Controlled

Abstract Background In addition to the beneficial health effects of being active, running is also associated with a risk of sustaining injuries. The online intervention Runfitcheck was developed to stimulate injury-preventive behaviour among adult novice runners. The objective of this study was to evaluate the effectiveness of Runfitcheck on injury-preventive behaviour among adult novice runners. Design Randomised controlled trial Methods A randomised controlled trial with a follow-up period of five months was conducted among adult novice runners. The intervention group had access to the Runfitcheck intervention, while the control group performed their running activities as usual. One, three, and five months after enrolment, participants reported retrospectively what they had done regarding injury-preventive behaviour (operationalised as (i) using a (personalised) training schedule; (ii) performing strength and technique exercises; and (iii) performing a warm-up routine prior to running). Relative Risks ((RR) and 95% Confidence Interval (95%CI)) were used to analyse behavioural change among runners who were not performing the favourable behaviour at enrolment. Results A total of 1,411 novice runners (72.6% female, mean age 38.1 years) were included in this study and assigned to the intervention group (n=715) or control group (n=696). Runners in the intervention group searched more often for information about a warm-up routine (55.6% versus 44.9%; RR 1.211 (95%CI 1.080-1.357); Table 2), and added more often strength exercises to their warm-up routine (49.3% versus 38.2%; RR 1.228 (95%CI 1.092-1.380)). Runners in the intervention group performed more often running technique exercises compared to runners in the control group (58.6% versus 51.5%; RR 1.134 (95%CI 1.015-1.267)), but less often strength exercises (71.9% versus 77.9%; RR 0.865 (95%CI 0.752-0.995)). Within the group of runners that did not perform any warm-up routine at enrolment (n=272; 69.5% female, mean age 35.8 years (SD 9.3), runners in the intervention group performed a regular warm-up routine more often than runners in the control group (47.1% versus 28.4%; n=196; RR 1.461 (95%CI 1.084-1.968)) No significant results were found for using a training schedule. Conclusions The online intervention Runfitcheck was effective in stimulating aspects of injury-preventive behaviour in adult novice runners, mostly related to a warm-up routine.

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A Web-Based Intervention for Users of Amphetamine-Type Stimulants: 3-Month Outcomes of a Randomized Controlled Trial

JMIR Mental Health ◽

10.2196/mental.3278 ◽

2014 ◽

Vol 1 (1) ◽

pp. e1 ◽

Cited By ~ 20

Author(s):

Robert J Tait ◽

Rebecca McKetin ◽

Frances Kay-Lambkin ◽

Bradley Carron-Arthur ◽

Anthony Bennett ◽

...

Keyword(s):

Drug Use ◽

Help Seeking ◽

Controlled Trial ◽

Intervention Group ◽

Control Group ◽

Web Based ◽

Randomized Controlled ◽

Time Interaction ◽

Days Out Of Role

Background Among illicit drugs, the prevalence of amphetamine-type stimulant (ATS) use is second only to cannabis. Currently, there are no approved pharmacotherapies for ATS problems, but some face-to-face psychotherapies are effective. Web-based interventions have proven to be effective for some substance use problems, but none has specifically targeted ATS users. Objective The objective of the study was to evaluate the effectiveness of a Web-based intervention for ATS problems on a free-to-access site compared with a waitlist control group. Methods We used a randomized controlled trial design. The primary outcome measure was self-reported ATS use in the past three months assessed using the Alcohol, Smoking, Substance Involvement Screening Test (ASSIST). Other measures included quality of life (EUROHIS score), psychological distress (K-10 score), days out of role, poly-drug use, general help-seeking intentions, actual help-seeking, and “readiness to change”. The intervention consisted of three fully automated, self-guided modules based on cognitive behavioral therapy and motivation enhancement. The analysis was an intention-to-treat analysis using generalized estimating equation models, with a group by time interaction as the critical assessment. Results We randomized 160 people (intervention n=81, control n=79). At three months, 35/81 (43%) intervention and 45/79 (57%) control participants provided follow-up data. In the intervention group, 51/81 (63%) completed at least one module. The only significant group by time interaction was for days out of role. The pre/post change effect sizes showed small changes (range d=0.14 to 0.40) favoring the intervention group for poly-drug use, distress, actual help-seeking, and days out of role. In contrast, the control group was favored by reductions in ATS use, improvements in quality of life, and increases in help-seeking intentions (range d=0.09 to 0.16). Conclusions This Web-based intervention for ATS use produced few significant changes in outcome measures. There were moderate, but nonsignificant reductions in poly-drug use, distress, days partially out of role, and increases in help-seeking. However, high levels of participant attrition, plus low levels of engagement with the modules, preclude firm conclusions being drawn on the efficacy of the intervention and emphasize the problems of engaging this group of clients in a fully automated program. Trial Registration Australian and New Zealand Clinical Trials Registry: ACTRN 12611000947909; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12611000947909 (Archived by WebCite at http://www.webcitation.org/6SHTxEnzP).

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Rapidly elevated levels of PGC-1α-b protein in human skeletal muscle after exercise: exploring regulatory factors in a randomized controlled trial

Journal of Applied Physiology ◽

10.1152/japplphysiol.01000.2014 ◽

2015 ◽

Vol 119 (4) ◽

pp. 374-384 ◽

Cited By ~ 17

Author(s):

Eva-karin Gidlund ◽

Mia Ydfors ◽

Susanna Appel ◽

Helene Rundqvist ◽

Carl Johan Sundberg ◽

...

Keyword(s):

Skeletal Muscle ◽

Human Skeletal Muscle ◽

Controlled Trial ◽

Exercise Bout ◽

Work Load ◽

Peak Oxygen Uptake ◽

Exercise Group ◽

Control Group ◽

Muscle Adaptation ◽

Regulatory Factors

Individuals with high skeletal muscle mitochondrial content have a lower risk to acquire cardiovascular and metabolic disease, obesity, and type II diabetes. Regular endurance training increases mitochondrial density through a complex network of transcriptional regulators that in an accumulated way are affected by each single exercise bout. The aim of the present study was to investigate the effect of a single exercise bout on the levels of PGC-1α and related regulatory factors important for the initial phase of skeletal muscle adaptation. Ten men and ten women were randomized to either an exercise group (60 min cycling at a work load corresponding to 70% of peak oxygen uptake) or a nonexercising control group. Skeletal muscle biopsies were taken before, at 30 min, and at 2, 6, and 24 h after the intervention. Twenty-two mRNA transcripts and five proteins were measured. With exercise, protein levels of PGC-1α-ex1b increased, and this elevation occurred before that of total PGC-1α protein. We also demonstrated the existence and postexercise expression pattern of two LIPIN-1 (LIPIN-1α and LIPIN-1β) and three NCoR1 (NCoR1-1, NCoR1-2, and NCoR1-3) isoforms in human skeletal muscle. The present study contributes new insights into the initial signaling events following a single bout of exercise and emphasizes PGC-1α-ex1b as the most exercise-responsive PGC-1α isoform.

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Moderators of Maintained Increase in Aerobic Exercise Among Aging Men and Women in a 4-Year Randomized Controlled Trial: The DR’s EXTRA Study

Journal of Physical Activity and Health ◽

10.1123/jpah.2014-0299 ◽

2015 ◽

Vol 12 (11) ◽

pp. 1477-1484 ◽

Cited By ~ 1

Author(s):

Leena Hakola ◽

Kai Savonen ◽

Pirjo Komulainen ◽

Maija Hassinen ◽

Rainer Rauramaa ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Aerobic Exercise ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Group ◽

Control Group ◽

Older Individuals ◽

Men And Women ◽

Exercise Interventions ◽

Randomized Controlled

Background:Little is known about factors that modify the effectiveness of exercise interventions in increasing exercise. We aimed to identify moderators of the effectiveness of aerobic exercise intervention in maintaining increased aerobic exercise among older individuals.Methods:The participants of a 4-year randomized controlled trial were a population sample of 1410 men and women aged 57 to 78 years. The aerobic exercise group included 185 individuals and the control group included 169 individuals who reported low aerobic exercise at baseline. Maintained increase in aerobic exercise was defined as at least 60-minute increase in moderate-to-heavy aerobic exercise per week from baseline to 2- and 4-year assessments.Results:Individuals in the aerobic exercise group were 2.5 (95% CI 1.5 to 3.9) times more likely to maintain increased aerobic exercise than those in the control group. Individuals aged < 68.5 years but not older individuals succeeded in maintaining increased aerobic exercise in the intervention group (P = .02 for interaction). Individuals who were past smokers (P = .02 for interaction), were working (P = .05 for interaction), or had symptoms of depression (P = .05 for interaction) succeeded better in maintaining increased aerobic exercise in the intervention group than other individuals.Conclusions:These findings help in more precise targeting of future exercise interventions among older individuals.

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The Effects of Aerobic Exercise on Psychological Functioning in Family Caregivers: Secondary Analyses of a Randomized Controlled Trial

Annals of Behavioral Medicine ◽

10.1093/abm/kaaa031 ◽

2020 ◽

Cited By ~ 1

Author(s):

Benjamin A Hives ◽

E Jean Buckler ◽

Jordan Weiss ◽

Samantha Schilf ◽

Kirsten L Johansen ◽

...

Keyword(s):

Aerobic Exercise ◽

Family Caregivers ◽

Caregiver Burden ◽

Psychological Functioning ◽

Exercise Intervention ◽

Controlled Trial ◽

Intervention Group ◽

Exercise Program ◽

Exercise Group ◽

Control Group

Abstract Background The responsibility and stress of being a family caregiver are associated with reduced physical and mental health. Purpose To examine whether a 24-week aerobic exercise program improves multiple aspects of psychological functioning in family caregivers. Methods Family caregivers of patients with Alzheimer’s disease and other dementias (n = 68) were recruited and randomized into either an aerobic exercise group (n = 34) or a waitlist control group (n = 34). The exercise group was assigned a 24-week aerobic training program that incrementally increased the intensity, duration, and frequency of the exercise program until 150 min of moderate to vigorous activity were completed per week by the ninth week. Twelve measures of psychological functioning were administered at baseline and compared with responses completed following the intervention. Results Multilevel modeling revealed significant decreases in caregiver burden (β = −4.60, 95% confidence interval [CI] = [−8.82, −0.38], RLMM2 = 0.11) and depression (β = −2.59, 95% CI = [−4.79, −0.38], RLMM2 = 0.13), as well as increases in mastery (β = 1.78, 95% CI = [0.09, 3.46], RLMM2 = .04) in the exercise intervention group compared to the control group. Conclusion Family caregivers report high levels of depression and caregiver burden. Engagement in a 24-week exercise intervention can ameliorate the perceived burden of caregiving, symptoms of depression, and their sense of mastery.

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Carer-held records for dementia: a controlled trial

International Psychogeriatrics ◽

10.1017/s1041610205002565 ◽

2005 ◽

Vol 18 (2) ◽

pp. 259-268 ◽

Cited By ~ 6

Author(s):

Rosemary Simpson ◽

Penny Wakefield ◽

Nicola Spiers ◽

Carol Jagger ◽

James Lindesay

Keyword(s):

Locus Of Control ◽

Internal Control ◽

Controlled Trial ◽

Intervention Group ◽

Shared Care ◽

External Control ◽

Control Group ◽

Significant Group ◽

Care Plans ◽

Time Interaction

Background: A carer-held record (CHR) was developed to enable carers to contribute to care plans for their relatives with dementia, alongside other professionals. The aim of this study was to establish whether CHRs provide any measurable benefits for carers, in the areas of health, stress, knowledge of dementia and locus of control.Methods: This was a controlled parallel-group trial involving 84 carer/patient pairs, drawn from all new referrals to two community mental health teams (CMHTs). Subjects from one CMHT were given CHRs. The control group from the other CMHT were not offered the initiative. Carers in both groups completed instruments measuring knowledge of dementia, carer stress and strain, carer health, and locus of control (internal, external, chance, shared care) at three time points: baseline, 6 months and 1 year.Results: Findings are reported for outcome at 6 months and 1 year on 51 carer/patient pairs. Having a CHR was associated with significantly reduced scores on the Carer Strain Index at 1 year (mean between-group difference: −1.34, 95% CI −2.67 to −0.02). Regarding locus of control, external control scores were significantly lower in the intervention group, by 2.5 points at 6 months (95% CI −4.82 to −0.18) and 3.43 points at 1 year (95% CI −5.57 to −1.29) (p = 0.01). There was a significant group by time interaction in chance control, with the difference in chance control between groups widening between 6 and 12 months. In the shared care dimension of locus of control, there was no difference at 6 months, but a significant group by time interaction, with the intervention group maintaining a higher level of internal control between 6 and 12 months, while the control group reduced. No significant differences were identified in the domains of carer health or knowledge of dementia.Conclusions: Although not a randomized controlled trial, and limited by smaller sample size than planned, this study indicates that use of CHRs provides some benefits for carers in the domains of carer strain and locus of control.

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Promoting the Community's Ability to Detect and Respond to Suicide Risk Through an Online Bystander Intervention Model-Informed Tool

Crisis ◽

10.1027/0227-5910/a000708 ◽

2020 ◽

pp. 1-7

Author(s):

Karien Hill ◽

Shawn Somerset ◽

Ralf Schwarzer ◽

Carina Chan

Keyword(s):

Suicide Prevention ◽

Suicide Risk ◽

Controlled Trial ◽

Intervention Group ◽

Bystander Intervention ◽

Self Report ◽

Innovative Technology ◽

Control Group ◽

Intervention Model ◽

Standard Material

Abstract. Background: The public health sector has advocated for more innovative, technology-based, suicide prevention education for the community, to improve their ability to detect and respond to suicide risk. Emerging evidence suggests addressing the bystander effect through the Bystander Intervention Model (BIM) in education material may have potential for suicide prevention. Aims: The current study aimed to assess whether BIM-informed tools can lead to improved readiness, confidence and intent in the community to detect and respond to suicide risk in others. Method: A sample of 281 adults recruited from the community participated in a randomized controlled trial comprising a factsheet designed according to the BIM (intervention group) and a standard factsheet about suicide and mental health (control group). Participants' self-reported detecting and responding to suicide risk readiness, confidence, and intent when presented with a suicidal peer was tested pre- and postintervention and compared across time and between groups. Results: The intervention group had significantly higher levels of detecting and responding to suicide risk readiness, confidence, and intent than the control group at postintervention (all p < .001) with moderate-to-large effect sizes. Limitations: The study was limited by a homogenous sample, too low numbers at follow-up to report, and self-report data only. Conclusion: This study demonstrates BIM-informed suicide prevention training may enhance the community's intervention readiness, confidence, and intent better than current standard material. Further testing in this area is recommended. While results were statistically significant, clinical significance requires further exploration.

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Breastfeeding Training through Role-Play and Effects on Mother-infant Attachment Behaviours: A Randomised Controlled Trial

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/6232 ◽

2020 ◽

Vol 22 (1) ◽

Author(s):

Farokh Saljughi ◽

Mitra Savabi-Esfahani ◽

Shahnaz Kohan ◽

Soheila Ehsanpour

Keyword(s):

Pregnant Women ◽

Maternal Employment ◽

Controlled Trial ◽

Role Play ◽

Intervention Group ◽

Control Group ◽

Maternal Behaviour ◽

Infant Attachment ◽

Significant Difference ◽

History Of

Mother-infant attachment is an intimate, lasting and satisfying relationship that leads to better cognitive, emotional and social growth of the infant. The aim of this study was to determine the effects of breastfeeding training by role-play on mother-infant attachment behaviours. This research was a randomised clinical trial (parallel design). Inclusion criteria were: no history of mental disorders; ability to read and write the Persian language to complete the questionnaire; no history of drug and tobacco intake in primigravida women. The sample comprised 100 pregnant women (in 2 groups), selected through simple random sampling at healthcare centres. The researcher reviewed prenatal care registries of selected healthcare centres and extracted the names of pregnant women in their early third trimester. The data were imported into randomisation software. The control group received routine breastfeeding training, while the intervention group received routine training together with training through role-play. The data collection tool was the Maternal Behaviour Inventory Questionnaire. Consequently 75 samples were analysed in SPSS16. Independent t-tests and chi-square tests were used to examine the difference between the two groups. Results showed that the mean score of mother-infant attachment one week after delivery was significantly higher in the intervention group in comparison to that in the control group (p<0.001). No significant difference was observed between the two groups in maternal age, age of marriage, neonatal gender, maternal employment and education, number of parity, and number of abortions (P>0.05). Since breastfeeding training through role-play could affect mother-infant attachment, it is suggested that this type of training should be provided for pregnant women to promote mother-infant attachment and exclusive breastfeeding.

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