scholarly journals Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study

2021 ◽  
Vol 7 (1) ◽  
Author(s):  
Peter Nymberg ◽  
Susanna Calling ◽  
Emelie Stenman ◽  
Karolina Palmér ◽  
Eva Ekvall Hansson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Study Design ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Activity Monitor ◽  
Activity Level ◽  
Self Report ◽  
Ethical Review ◽  
Mixed Effect ◽  
Registration Number

Abstract Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses physical activity on prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such an association. Aim Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables. Method Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed-effect model to account for repeated observations and estimate differences both within groups and between groups at 3- and 6-months follow-up. Results Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 min) was low according to the stated feasibility criteria. Eleven participants were excluded from analysis due to low activity monitor wear time. Neither the activity monitor data nor self-reported physical activity showed any significant differences between the groups. Conclusion The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone. Trial registration ClinicalTrials.gov, registration number NCT02869854. Regional Ethical Review Board in Lund registration number 2016/404.

scholarly journals Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study.

2020 ◽  
Author(s):  
Peter Nymberg ◽  
Susanna Calling ◽  
Emelie Stenman ◽  
Karolina Palmér ◽  
Eva Ekvall Hansson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Study Design ◽  
Controlled Trial ◽  
Dropout Rate ◽  
Activity Monitor ◽  
Activity Level ◽  
Self Report ◽  
Ethical Review ◽  
Mixed Effect ◽  
Registration Number

Abstract Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses Physical Activity on Prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such associations.Aim: Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables. Method: Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed effect model to account for repeated observations and estimate differences between groups at three- and six-months follow-up.Results: Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 minutes) was low according to the stated feasibility criteria. Eleven participants were excluded from analysis due to low activity monitor wear time. Neither the activity monitor data nor self-reported physical activity showed any significant differences between the groups.Conclusion: The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone. Trial registration: ClinicalTrials.gov, registration number NCT02869854. Regional Ethical Review Board in Lund registration number 2016/404.

scholarly journals Effect of mindfulness on physical activity in primary healthcare patients: a randomised controlled trial pilot study.

2020 ◽  
Author(s):  
Peter Nymberg ◽  
Susanna Calling ◽  
Emelie Stenman ◽  
Karolina Palmér ◽  
Eva Ekvall Hansson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Study Design ◽  
Dropout Rate ◽  
Activity Monitor ◽  
Activity Level ◽  
The Other ◽  
Mixed Effect ◽  
Self Rated Health ◽  
Significant Difference ◽  
Registration Number

Abstract Increased physical activity can have health benefits among inactive individuals. In Sweden, the healthcare system uses Physical Activity on Prescription (PAP) to motivate patients to increase their physical activity level. Mindfulness may further heighten the internal motivation to engage in physical activity. However, previous research has not demonstrated clear evidence of such associations.Aim: Examine the feasibility of the study design as a preparation for a full-scale study, and examine the differences, between three interventions, in change over time in physical activity levels and in related variables.Method: Comparison between three different interventions in an ordinary primary health care setting: PAP, mindfulness, and a combination of PAP and mindfulness. Physical activity was measured with self-report and ACTi Graph GT1X activity monitor. Statistical analysis was performed with a mixed effect model to account for repeated observations and estimate differences both within groups and between groups at three and six months follow-up.Results: Between September 2016 and December 2018, a total of 88 participants were randomised into three groups. Eleven participants were excluded from analysis due to low activity monitor wear time. The total dropout rate was 20.4%, the attendance rate to the mindfulness courses (52% > 6 times) and the web-based mindfulness training (8% > 800 minutes) was low according to the stated feasibility criteria. Self-reported leisure time physical activity showed a significant difference in change between the groups (p= 0.04); the mindfulness group did not report the same increase as the other groups. The activity monitor data showed no significant differences between the groups. However, within the combination group, there was a significant increase of percentage time in light physical activity, which was not found in the other groups. Among the secondary aims, self-rated health showed a significant increase only within the combination group.Conclusion: The study design needs adjustment for the mindfulness intervention design before a fully scaled study can be conducted. A combination of PAP and mindfulness may increase physical activity and self-rated health more than PAP or mindfulness alone.Trial registration: ClinicalTrials.gov, registration number NCT02869854. Regional Ethical Review Board in Lund registration number 2016/404.

scholarly journals The “Healthy Habits, Healthy Girls” randomized controlled trial for girls: study design, protocol, and baseline results

2015 ◽  
Vol 31 (7) ◽  
pp. 1381-1394 ◽  
Author(s):  
Ana Carolina Barco Leme ◽  
Sonia Tucunduva Philippi
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Waist Circumference ◽  
Study Design ◽  
Controlled Trial ◽  
Vigorous Physical Activity ◽  
Activity Level ◽  
Randomized Controlled ◽  
Healthy Habits ◽  
Design Protocol

The purpose of this article is to describe the study design, protocol, and baseline results of the “Healthy Habits, Healthy Girls” program. The intervention is being evaluated through a randomized controlled trial in 10 public schools in the city of São Paulo, Brazil. Data on the following variables were collected and assessed at baseline and will be reevaluated at 7 and 12 months: body mass index, waist circumference, dietary intake, nutrition, physical activity, social cognitive mediators, physical activity level, sedentary behaviors, self-rated physical status, and overall self-esteem. According to the baseline results, 32.4% and 23.4% of girls were overweight in the intervention and control groups, respectively, and in both groups a higher percentage failed to meet daily recommendations for moderate and vigorous physical activity and maximum screen time (TV, computer, mobile devices). There were no significant differences between the groups for most of the variables, except age (p = 0.000) and waist circumference (p = 0.014). The study showed a gap in the Brazilian literature on protocols for randomized controlled trials to prevent obesity among youth. The current study may thus be an important initial contribution to the field.

Abstract P145: Using an Activity Monitor to Motivate Physical Activity among Healthy Employees: A Randomized Controlled Trial

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Anne N Thorndike ◽  
Sarah Mills ◽  
Lillian Sonnenberg ◽  
Susan Regan
Keyword(s):  
Physical Activity ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Activity Monitor ◽  
Activity Level ◽  
Similar Proportion ◽  
Second Phase ◽  
Entire Study ◽  
Randomized Controlled ◽  
Steps Per Day

Background: Worksite physical activity programs have the potential to reduce sedentary behavior of large populations of employees. Activity monitors are promising tools for motivating individuals to increase physical activity, but it is unknown whether this is an effective strategy for a relatively healthy employee population. Methods: We conducted a 2-phase trial to assess the effectiveness of providing 102 internal medicine residents with an activity monitor for 12 weeks. The first phase (6 weeks) was a randomized controlled trial (RCT) with half of the residents randomized to wear a monitor with visible feedback (steps, calories, activity level) and half the residents randomized to wear a blinded monitor (control). The second phase (6 weeks) was a team competition (TC), and all residents were unblinded and divided into 3 teams (interns, juniors, seniors) that competed on weekly steps. To increase compliance over 12 weeks, we conducted a weekly lottery for two $10 gift cards among subjects who wore the monitor for at least 5 of 7 days. Pedometer use (defined as > 500 steps/day) was compared across groups using chi-squared tests. We compared mean daily steps on days when pedometer was worn between control and intervention groups using generalized linear mixed models with participant as a random effect. Results: Baseline demographics and weight did not differ between control and intervention. Mean age was 29, 54% were female, and mean BMI was 24.2. Mean daily steps at baseline (week 1) were 8,084 (SD 3565). During the RCT phase (6 weeks), control and intervention groups did not differ in mean daily steps, but over the entire study (12 weeks), the intervention group logged 403 more steps per day than control (p<.001). During the 6- week TC phase, subjects logged 297 more steps per day than during the 6-week RCT (p=.001). A similar proportion of subjects from both groups wore the pedometer during the 6-week RCT (75%), but despite unblinding during the second 6 weeks (TC), pedometer usage was lower in the control group compared to intervention (55% vs. 63%, p<.001). Conclusions: Compliance with using an activity monitor in this young employee population was relatively high but started to decrease after 6 weeks. Although the effect size was small, providing an activity monitor and creating a team competition was effective for motivating employees to increase activity over the short term. Future study is needed to evaluate long-term effectiveness among a more sedentary population.

scholarly journals Ambulatory oxygen for treatment of exertional hypoxaemia in pulmonary fibrosis (PFOX trial): a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040798
Author(s):  
Anne E Holland ◽  
Tamera Corte ◽  
Daniel C Chambers ◽  
Andrew J Palmer ◽  
Magnus Per Ekström ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Interstitial Lung Disease ◽  
Randomised Controlled Trial ◽  
Lung Disease ◽  
Oxygen Therapy ◽  
Controlled Trial ◽  
Activity Level ◽  
Anxiety And Depression ◽  
Randomised Controlled

IntroductionInterstitial lung diseases are characterised by scarring of lung tissue that leads to reduced transfer of oxygen into the blood, decreased exercise capacity and premature death. Ambulatory oxygen therapy may be used to treat exertional oxyhaemoglobin desaturation, but there is little evidence to support its efficacy and there is wide variation in clinical practice. This study aims to compare the clinical efficacy and cost-effectiveness of ambulatory oxygen versus ambulatory air in people with fibrotic interstitial lung disease and exertional desaturation.Methods and analysisA randomised, controlled trial with blinding of participants, clinicians and researchers will be conducted at trial sites in Australia and Sweden. Eligible participants will be randomised 1:1 into two groups. Intervention participants will receive ambulatory oxygen therapy using a portable oxygen concentrator (POC) during daily activities and control participants will use an identical POC modified to deliver air. Outcomes will be assessed at baseline, 3 months and 6 months. The primary outcome is change in physical activity measured by number of steps per day using a physical activity monitor (StepWatch). Secondary outcomes are functional capacity (6-minute walk distance), health-related quality of life (St George Respiratory Questionnaire, EQ-5D-5L and King’s Brief Interstitial Lung Disease Questionnaire), breathlessness (Dyspnoea-12), fatigue (Fatigue Severity Scale), anxiety and depression (Hospital Anxiety and Depression Scale), physical activity level (GENEActive), oxygen saturation in daily life, POC usage, and plasma markers of skeletal muscle metabolism, systematic inflammation and oxidative stress. A cost-effectiveness evaluation will also be undertaken.Ethics and disseminationEthical approval has been granted in Australia by Alfred Hospital Human Research Ethics Committee (HREC/18/Alfred/42) with governance approval at all Australian sites, and in Sweden (Lund Dnr: 2019-02963). The results will be published in peer-reviewed scientific journals, presented at conferences and disseminated to consumers in publications for lay audiences.Trial registration numberClinicalTrials.gov Registry (NCT03737409).

scholarly journals ‘Tracking Together’—Simultaneous Use of Human and Dog Activity Trackers: Protocol for a Factorial, Randomized Controlled Pilot Trial

2021 ◽  
Vol 18 (4) ◽  
pp. 1561
Author(s):  
Wasantha Jayawardene ◽  
Lesa Huber ◽  
Jimmy McDonnell ◽  
Laurel Curran ◽  
Sarah Larson ◽  
...  
Keyword(s):  
Physical Activity ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Activity Level ◽  
Analysis Of Covariance ◽  
Moderate Intensity ◽  
Randomized Controlled ◽  
Activity Trackers ◽  
Dog Owners ◽  
Simultaneous Use

Dog-walkers are more likely to achieve moderate-intensity physical activity. Linking the use of activity trackers with dog-walking may be beneficial both in terms of improving the targeted behavior and increasing the likelihood of sustained use. This manuscript aims to describe the protocol of a pilot study which intends to examine the effects of simultaneous use of activity trackers by humans and their dogs on the physical activity level of humans and dogs. This study uses nonprobability sampling of dog owners of age 25–65 (N = 80) and involves four parallel groups in an observational randomized controlled trial with a 2 × 2 factorial design, based on use of dog or human activity trackers for eight weeks. Each group consists of dog-human duos, in which both, either or none are wearing an activity tracker for eight weeks. At baseline and end, all human subjects wear ActiGraph accelerometers that quantify physical activity for one week. Commercial activity trackers are used for tracking human and dog activity remotely. Additional measures for humans are body composition and self-reported physical activity. Dog owners also report dog’s weight and physical activity using a questionnaire. A factorial analysis of covariance (ANCOVA) is used to compare physical activity across the four groups from baseline to week-10.

scholarly journals Effectiveness of a hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burn injuries: a prospective randomised controlled trial

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e039981
Author(s):  
Maleea Denise Holbert ◽  
Roy M Kimble ◽  
Mark Chatfield ◽  
Bronwyn R Griffin
Keyword(s):  
Randomised Controlled Trial ◽  
Repeated Measures ◽  
Controlled Trial ◽  
Geometric Mean ◽  
First Aid ◽  
Self Report ◽  
Thermal Burn ◽  
Pain Scores ◽  
Registration Number ◽  
Randomised Controlled

ObjectiveTo compare the effectiveness of two acute burn dressings, Burnaid hydrogel dressing and plasticised polyvinylchloride film, on reducing acute pain scores in paediatric burn patients following appropriate first aid.DesignSingle-centre, superiority, two-arm, parallel-group, prospective randomised controlled trial.Participants and settingPaediatric patients (aged ≤16) presenting to the Emergency Department at the Queensland Children’s Hospital, Brisbane, Australia, with an acute thermal burn were approached for participation in the trial from September 2017–September 2018.InterventionsPatients were randomised to receive either (1) Burnaid hydrogel dressing (intervention) or (2) plasticised polyvinylchloride film (Control) as an acute burn dressing.Primary and secondary outcomesObservational pain scores from nursing staff assessed 5 min post application of the randomised dressing, measured using the Face Legs Activity Cry and Consolability Scale was the primary outcome. Repeated measures of pain, stress and re-epithelialisation were also collected at follow-up dressing changes until 95% wound re-epithelialisation occurred.ResultsSeventy-two children were recruited and randomised (n=37 intervention; n=35 control). No significant between-group differences in nursing (mean difference: −0.1, 95% CI −0.7 to 0.5, p=0.72) or caregiver (MD: 1, 95% CI −8 to 11, p=0.78) observational pain scores were identified. Moreover, no significant differences in child self-report pain (MD: 0.3, 95% CI −1.7 to 2.2, p=0.78), heart rate (MD: −3, 95% CI −11 to 5, p=0.41), temperature (MD: 0.6, 95% CI −0.13 to 0.24, p=0.53), stress (geometric mean ratio: 1.53, 95% CI 0.93 to 2.53, p=0.10), or re-epithelialisation rates (MD: −1, 95% CI −3 to 1, p=0.26) were identified between the two groups.ConclusionsA clear benefit of Burnaid hydrogel dressing as an analgesic adjunct to first aid for the treatment of acute paediatric burns was not identified in this investigation.Trial registration numberAustralian New Zealand Clinical Trials Registry (ACTRN12617001274369).

‘No one ever asked us’: a feasibility study assessing the co-creation of a physical activity programme with adolescent girls

2019 ◽  
Vol 27 (3) ◽  
pp. 34-43
Author(s):  
Méabh Corr ◽  
Elaine Murtagh
Keyword(s):  
Physical Activity ◽  
Data Collection ◽  
Behaviour Change ◽  
Adolescent Girls ◽  
Retention Rate ◽  
Controlled Trial ◽  
Activity Level ◽  
Health Concern ◽  
Post Intervention ◽  
Behaviour Change Wheel

Background: Globally, the poor activity level of adolescent girls is a public health concern. Little research has involved adolescents in the design of interventions. This study assessed the feasibility of involving girls in the co-creation of an activity programme. Methods: Thirty-one students (15–17 years old) were recruited from a post-primary school. The Behaviour Change Wheel guided intervention design, providing insights into participants’ capability, opportunity and motivation for change. Step counts and self-reported physical activity levels were recorded pre- and post-intervention. Feasibility benchmarks assessed recruitment, data collection, acceptability and adherence. Results: Activity and educational sessions were delivered for six weeks during physical education class. Average attendance was 87% (benchmark = 80%). Eligibility was 61% (benchmark = 60%). There was a 100% retention rate (benchmark = 90%). All participants ( n = 31) completed baseline measures and 71% ( n = 22) completed post-measures. 54% ( n = 17) of students completed pedometer measurements, with 32% ( n = 10) having complete data. Average daily steps were 13,121 pre-intervention and 14,128 post-intervention ( p > 0.05). Data collection was feasible, receiving a mean score > 4/5 (benchmark > 3.5/5). Conclusions: The Behaviour Change Wheel can be used to co-create an activity programme with adolescent girls. Predetermined benchmarks, except for pedometer recordings, were reached or exceeded, providing evidence for the need of a randomised controlled trial to test effectiveness.

scholarly journals Cognitive-behavioural therapy (CBT) for renal fatigue (BReF): a feasibility randomised-controlled trial of CBT for the management of fatigue in haemodialysis (HD) patients

BMJ Open ◽  
2018 ◽  
Vol 8 (3) ◽  
pp. e020842 ◽  
Author(s):  
Federica Picariello ◽  
Rona Moss-Morris ◽  
Iain C Macdougall ◽  
Sam Norton ◽  
Maria Da Silva-Gane ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cognitive Behavioural Therapy ◽  
Controlled Trial ◽  
Behavioural Therapy ◽  
Self Report ◽  
Behavioural Responses ◽  
Feasibility Randomised Controlled Trial ◽  
Cognitive Behavioural ◽  
Potential Benefits ◽  
Randomised Controlled

IntroductionFatigue is one of the most common and disabling symptoms in end-stage kidney disease, particularly among in-centre haemodialysis patients. This two-arm parallel group feasibility randomised controlled trial will determine whether a fully powered efficacy trial is achievable by examining the feasibility of recruitment, acceptability and potential benefits of a cognitive-behavioural therapy (CBT)-based intervention for fatigue among in-centre haemodialysis patients.MethodsWe aim to recruit 40 adult patients undergoing in-centre haemodialysis at secondary care outpatient dialysis units, who meet clinical levels of fatigue. Patients will be randomised individually (using a 1:1 ratio) to either a 4–6 weeks’ CBT-based intervention (intervention arm) or to a waiting-list control (control arm). The primary feasibility outcomes include descriptive data on numbers within each recruiting centre meeting eligibility criteria, rates of recruitment, numbers retained postrandomisation and treatment adherence. To assess the potential benefits of the cognitive-behavioural therapy for renal fatigue intervention, secondary self-report outcomes include measures of fatigue severity (Chalder Fatigue Questionnaire), fatigue-related functional impairment (Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index), depression (Patient Health Questionnaire-9) and anxiety (Generalised Anxiety Disorder-7). Changes in fatigue perceptions (Brief Illness Perception Questionnaire), cognitive and behavioural responses to fatigue (Cognitive and Behavioural Responses to Symptoms Questionnaire), sleep hygiene behaviours (Sleep Hygiene Index) and physical activity (International Physical Activity Questionnaire–short form) will also be explored. These self-report measures will be collected at baseline and 3 months postrandomisation. Nested qualitative interviews will be conducted postintervention to explore the acceptability of the intervention and identify any areas in need of improvement. The statistician and assessor will be blinded to treatment allocation.Ethics and disseminationA National Health Service (NHS) Research Ethics Committee approved the study. Any amendments to the protocol will be submitted to the NHS Committee and study sponsor.Trial registration numberISRCTN91238019;Pre-results.

Efficacy of an E-Mail Intervention for the Promotion of Physical Activity and Nutrition Behavior in the Workplace Context

2005 ◽  
Vol 19 (6) ◽  
pp. 422-429 ◽  
Author(s):  
Ronald C. Plotnikoff ◽  
Linda J. McCargar ◽  
Philip M. Wilson ◽  
Constantinos A. Loucaides
Keyword(s):  
Physical Activity ◽  
Mode Of Delivery ◽  
Intervention Group ◽  
Activity Level ◽  
Self Report ◽  
Control Group ◽  
Nutrition Behavior ◽  
Nutrition Messages ◽  
Mail Address ◽  
E Mail

Purpose. The purpose of this study was to evaluate a 12-week workplace e-mail intervention designed to promote physical activity and nutrition behavior. Design. A pre- and post-test design was conducted to compare the effects of e-mail messages between intervention and control groups. Setting. Five large workplaces in Alberta, Canada. Subjects. Employees with access to a personal e-mail address (N = 2121) were randomly assigned to an intervention (n = 1566) or a control group (n = 555). Intervention. Physical activity and nutrition messages were based on social-cognitive theories. The intervention group received one physical activity and one parallel nutrition message per week for 12 weeks. The control group received no weekly messages. Measures. Each participant completed self-report measures of physical activity and nutrition related to knowledge, attitudes, and behaviors 1 week before (time 1) and 1 week after (time 2) the intervention. Results. The intervention group was more efficacious at time 2 on measures of self-efficacy, pros, cons, intentions, and behavior related to physical activity. This group also reported more favorable changes in practicing healthy eating, balancing food intake with activity level, cooking meals with techniques to reduce fat, and avoiding eating high-fat foods. Effect sizes for all significant differences were small. Conclusion. E-mail is a promising mode of delivery for promoting physical activity and nutrition in the workplace. Further theoretically driven studies are needed.

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