Dataset Information

Face masks while exercising trial (MERIT): a cross-over randomised controlled study.

ABSTRACT:

Objectives

Physical exertion is a high-risk activity for aerosol emission of respiratory pathogens. We aimed to determine the safety and tolerability of healthy young adults wearing different types of face mask during moderate-to-high intensity exercise.

Design

Cross-over randomised controlled study, completed between June 2021 and January 2022.

Participants

Volunteers aged 18-35 years, who exercised regularly and had no significant pre-existing health conditions.

Interventions

Comparison of wearing a surgical, cloth and filtering face piece (FFP3) mask to no mask during 4×15 min bouts of exercise. Exercise was running outdoors or indoor rowing at moderate-to-high intensity, with consistency of distance travelled between bouts confirmed using a smartphone application (Strava). Each participant completed each bout in random order.

Outcomes

The primary outcome was change in oxygen saturations. Secondary outcomes were change in heart rate, perceived impact of face mask wearing during exercise and willingness to wear a face mask for future exercise.

Results

All 72 volunteers (mean age 23.9) completed the study. Changes in oxygen saturations did not exceed the prespecified non-inferiority margin (2% difference) with any mask type compared with no mask. At the end of exercise, the estimated average difference in oxygen saturations for cloth mask was -0.07% (95% CI -0.39% to 0.25%), for surgical 0.28% (-0.04% to 0.60%) and for FFP3 -0.21% (-0.53% to 0.11%). The corresponding estimated average difference in heart rate for cloth mask was -1.20 bpm (95% CI -4.56 to 2.15), for surgical 0.36 bpm (95% CI -3.01 to 3.73) and for FFP3 0.52 bpm (95% CI -2.85 to 3.89). Wearing a face mask caused additional symptoms such as breathlessness (n=13, 18%) and dizziness (n=7, 10%). 33 participants broadly supported face mask wearing during exercise, particularly indoors, but 22 were opposed.

Conclusion

This study adds to previous findings (mostly from non-randomised studies) that exercising at moderate-to-high intensity wearing a face mask appears to be safe in healthy, young adults.

Trial registration number

NCT04932226.

SUBMITTER: Jones N

PROVIDER: S-EPMC9827243 | biostudies-literature | 2023 Jan

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Face masks while exercising trial (MERIT): a cross-over randomised controlled study.

Jones Nicholas N Oke Jason J Marsh Seren S Nikbin Kurosh K Bowley Jonathan J Dijkstra H Paul HP Hobbs Fd Richard FR Greenhalgh Trisha T

BMJ open 20230105 1

<h4>Objectives</h4>Physical exertion is a high-risk activity for aerosol emission of respiratory pathogens. We aimed to determine the safety and tolerability of healthy young adults wearing different types of face mask during moderate-to-high intensity exercise.<h4>Design</h4>Cross-over randomised controlled study, completed between June 2021 and January 2022.<h4>Participants</h4>Volunteers aged 18-35 years, who exercised regularly and had no significant pre-existing health conditions.<h4>Interv ...[more]

PMID: 36604128

Similar Datasets

Project description:BackgroundLevels of physical activity (PA) in UK children are much lower than recommended and novel approaches to its promotion are needed. The Children, Parents and Pets Exercising Together (CPET) study is the first exploratory randomised controlled trial (RCT) to develop and evaluate an intervention aimed at dog-based PA promotion in families. CPET aimed to assess the feasibility, acceptability and potential efficacy of a theory-driven, family-based, dog walking intervention for 9-11 year olds.MethodsTwenty-eight families were allocated randomly to either receive a 10-week dog based PA intervention or to a control group. Families in the intervention group were motivated and supported to increase the frequency, intensity and duration of dog walking using a number of behaviour change techniques. Parents in the intervention group were asked to complete a short study exit questionnaire. In addition, focus groups with parents and children in the intervention group, and with key stakeholders were undertaken. The primary outcome measure was 10 week change in total volume of PA using the mean accelerometer count per minute (cpm). Intervention and control groups were compared using analysis of covariance. Analysis was performed on an intention to treat basis.ResultsTwenty five families were retained at follow up (89%) and 97% of all outcome data were collected at baseline and follow up. Thirteen of 14 (93%) intervention group parents available at follow up completed the study exit questionnaire and noted that study outcome measures were acceptable. There was a mean difference in child total volume of PA of 27 cpm (95% CI -70, 123) and -3 cpm (95% CI -60, 54) for intervention and control group children, respectively. This was not statistically significant. Approximately 21% of dog walking time for parents and 39% of dog walking time for children was moderate-vigorous PA.ConclusionsThe acceptability of the CPET intervention and outcome measures was high. Using pet dogs as the agent of lifestyle change in PA interventions in children and their parents is both feasible and acceptable, but did not result in a significant increase in child PA in this exploratory trial.Trial registrationISRCTN85939423.

Project description:BackgroundText messaging systems are used to collect data on symptom prevalence. Using a text messaging system, we evaluated the effects of question load, question frequency, and financial incentive on response rates and reported infant diarrhoea rates in an infant diarrhoea survey.MethodsWe performed a factorial cross-over randomised controlled trial of an SMS surveying system for infant diarrhoea surveillance with treatments: financial incentive (yes/no), question load (1-question/3-question), and questioning frequency (daily/fortnightly). Participants progressed through all treatment combinations over eight two-week rounds. Data were analysed using multivariable logistic regressions to determine the impacts of the treatments on the response rates and reported diarrhoea rates. Attitudes were explored through qualitative interviews.ResultsFor the 141 participants, the mean response rate was 47%. In terms of percentage point differences (ppd), daily questioning was associated with a lower response rate than fortnightly (- 1·2[95%CI:-4·9,2·5]); high (3-question) question loads were associated with a lower response rate than low (1-question) question loads (- 7·0[95%CI:- 10·8,-3·1]); and financial incentivisation was associated with a higher response rate than no financial incentivisation (6·4[95%CI:2·6,10·2]). The mean two-week diarrhoea rate was 36·4%. Daily questioning was associated with a higher reported diarrhoea rate than fortnightly (29·9[95%CI:22·8,36·9]); with little evidence for impact by incentivisation or question load.ConclusionsClose to half of all participants responded to the SMS survey. Daily questioning evoked a statistically higher rate of reported diarrhoea, while financial incentivisation and low (1-question) question loads evoked higher response rates than no incentive and high (3-question) question loads respectively.Trial registrationThe protocol was prospectively registered on ISRCTN on the 20th of March 2019 under number ISRCTN11410773 .

Project description:IntroductionRecurrent urinary tract infections (RUTIs) have a significant negative impact on quality of life and healthcare costs. To date, daily prophylactic antibiotics are the only treatment which have been shown to help prevent RUTIs. D-mannose is a type of sugar which is believed to inhibit bacterial adherence to uroepithelial cells, and is already being used by some women in an attempt to prevent RUTIs. There is currently insufficient rigorous evidence on which to base decisions about its use. The D-mannose to prevent recurrent urinary tract infections (MERIT) study will evaluate whether D-mannose is clinically and cost-effective in reducing frequency of infection and symptom burden for women presenting to UK primary care with RUTI.Methods and analysisMERIT will be a two-arm, individually randomised, double blind placebo controlled, pragmatic trial. Participants will be randomised to take D-mannose powder or placebo powder daily for 6 months. The primary outcome will be the number of medical attendances attributable to symptoms of RUTI. With 508 participants we will have 90% power to detect a 50% reduction in the chance of a further clinically suspected UTI, assuming 20% lost to follow-up. Secondary outcomes will include: number of days of moderately bad symptoms of UTI; time to next consultation; number of clinically suspected UTIs; number of microbiologically proven UTIs; number of antibiotic courses for UTI; quality of life and healthcare utilisation related to UTI. A within trial economic evaluation will be conducted to examine cost-effectiveness of D-mannose in comparison with placebo. A nested qualitative study will explore participants' experiences and perceptions of recruitment to, and participation in a study requiring a daily treatment.Ethics and disseminationEthical approval has been obtained from South West-Central Bristol Research Ethics Committee. Publication of the MERIT study is anticipated to occur in 2021.Trial registration numberISRCTN 13283516.

Project description:The aim of this trial was to compare the effectiveness of two generations of progressive lenses for presbyopia.A multicenter cross-over randomized controlled trial performed in a primary care setting (5 optical dispensaries) was planned. Two categories of progressive lenses were compared: 1) a new-generation lens (i.e., VARILUX PANAMIC ORMA CRIZAL), which is expensive but a supposed improvement in comfort, and 2) an older-generation lens (i.e., VARILUX CONFORT ORMA CRIZAL), which is less expensive and is considered the reference lens. Patients were randomized to wear one generation of progressive lens for 4 weeks, then cross over to wear the other lens for 4 weeks, without knowing the sequence of lenses. Inclusion criteria were 1) age 43-60 years; 2) outpatients already wearing progressive lenses and referred to an optician ophthalmologist for optical correction prescription within the last 6 months; 3) receiving a correction of </=3 dioptres in cases of associated myopia, hyperopia or astigmatism; 4) understanding and speaking French and able to answer a questionnaire; and 5) giving written consent to participate in the study.The primary outcome was patient preference for one progressive lens at week 8. Secondary outcomes were subjective measures of bifocal visual performance, including a) near visual acuity, b) visual field, c) kinetic visual skills, d) visual adaptability, e) visual comfort, and f) rapidity of adaptation.127 patients were randomized to one of the lens groups. Two patients withdrew prematurely; 98.4% and 97.6% patients who wore the new versus older lenses, respectively, wore their progressive lenses every day during the 4-week period 1 and period 2. The number of participants in each of 5 centres varied from 16 (12.6%) to 35 (27.6%).57.9% patients preferred the new-generation lenses, 36.5% the older-generation lenses, and 5.6% had no preference (p = 0.01). The two groups did not differ in any of the measures of bifocal visual performance except near visual acuity.Patients with presbyopia had slightly higher preference for the new-generation than older-generation lens, with no difference in lens groups for most of the visual outcomes assessed.ClinicalTrials.gov NCT00635115.

Dataset Information

Face masks while exercising trial (MERIT): a cross-over randomised controlled study.

Objectives

Design

Participants

Interventions

Outcomes

Results

Conclusion

Trial registration number

Publications

Face masks while exercising trial (MERIT): a cross-over randomised controlled study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets