scholarly journals Effect of exercise training for five years on all cause mortality in older adults—the Generation 100 study: randomised controlled trial

BMJ ◽  
2020 ◽  
pp. m3485
Author(s):  
Dorthe Stensvold ◽  
Hallgeir Viken ◽  
Sigurd L Steinshamn ◽  
Håvard Dalen ◽  
Asbjørn Støylen ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Absolute Risk ◽  
Controlled Trial ◽  
Absolute Risk Reduction ◽  
Control Group ◽  
Activity Levels ◽  
Percentage Points ◽  
All Cause Mortality ◽  
Randomised Controlled

AbstractObjectiveTo evaluate the effect of five years of supervised exercise training compared with recommendations for physical activity on mortality in older adults (70-77 years).DesignRandomised controlled trial.SettingGeneral population of older adults in Trondheim, Norway.Participants1567 of 6966 individuals born between 1936 and 1942.InterventionParticipants were randomised to two sessions weekly of high intensity interval training at about 90% of peak heart rate (HIIT, n=400), moderate intensity continuous training at about 70% of peak heart rate (MICT, n=387), or to follow the national guidelines for physical activity (n=780; control group); all for five years.Main outcome measureAll cause mortality. An exploratory hypothesis was that HIIT lowers mortality more than MICT.ResultsMean age of the 1567 participants (790 women) was 72.8 (SD 2.1) years. Overall, 87.5% of participants reported to have overall good health, with 80% reporting medium or high physical activity levels at baseline. All cause mortality did not differ between the control group and combined MICT and HIIT group. When MICT and HIIT were analysed separately, with the control group as reference (observed mortality of 4.7%), an absolute risk reduction of 1.7 percentage points was observed after HIIT (hazard ratio 0.63, 95% confidence interval 0.33 to 1.20) and an absolute increased risk of 1.2 percentage points after MICT (1.24, 0.73 to 2.10). When HIIT was compared with MICT as reference group an absolute risk reduction of 2.9 percentage points was observed (0.51, 0.25 to 1.02) for all cause mortality. Control participants chose to perform more of their physical activity as HIIT than the physical activity undertaken by participants in the MICT group. This meant that the controls achieved an exercise dose at an intensity between the MICT and HIIT groups.ConclusionThis study suggests that combined MICT and HIIT has no effect on all cause mortality compared with recommended physical activity levels. However, we observed a lower all cause mortality trend after HIIT compared with controls and MICT.Trial registrationClinicalTrials.gov NCT01666340.

scholarly journals Protocol for the PreventIT feasibility randomised controlled trial of a lifestyle-integrated exercise intervention in young older adults

BMJ Open ◽  
2019 ◽  
Vol 9 (3) ◽  
pp. e023526 ◽  
Author(s):  
Kristin Taraldsen ◽  
A Stefanie Mikolaizak ◽  
Andrea B Maier ◽  
Elisabeth Boulton ◽  
Kamiar Aminian ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Exercise Intervention ◽  
Controlled Trial ◽  
Functional Decline ◽  
Control Group ◽  
Feasibility Randomised Controlled Trial ◽  
Randomised Controlled ◽  
Life Function

IntroductionThe European population is rapidly ageing. In order to handle substantial future challenges in the healthcare system, we need to shift focus from treatment towards health promotion. The PreventIT project has adapted the Lifestyle-integrated Exercise (LiFE) programme and developed an intervention for healthy young older adults at risk of accelerated functional decline. The intervention targets balance, muscle strength and physical activity, and is delivered either via a smartphone application (enhanced LiFE, eLiFE) or by use of paper manuals (adapted LiFE, aLiFE).Methods and analysisThe PreventIT study is a multicentre, three-armed feasibility randomised controlled trial, comparing eLiFE and aLiFE against a control group that receives international guidelines of physical activity. It is performed in three European cities in Norway, Germany, and The Netherlands. The primary objective is to assess the feasibility and usability of the interventions, and to assess changes in daily life function as measured by the Late-Life Function and Disability Instrument scale and a physical behaviour complexity metric. Participants are assessed at baseline, after the 6 months intervention period and at 1 year after randomisation. Men and women between 61 and 70 years of age are randomly drawn from regional registries and respondents screened for risk of functional decline to recruit and randomise 180 participants (60 participants per study arm).Ethics and disseminationEthical approval was received at all three trial sites. Baseline results are intended to be published by late 2018, with final study findings expected in early 2019. Subgroup and further in-depth analyses will subsequently be published.Trial registration numberNCT03065088; Pre-results.

scholarly journals Effects of a traditional Chinese mind–body exercise, Baduanjin, on the physical and cognitive functions in the community of older adults with cognitive frailty: study protocol for a randomised controlled trial

BMJ Open ◽  
2020 ◽  
Vol 10 (4) ◽  
pp. e034965
Author(s):  
Rui Xia ◽  
Mingyue Wan ◽  
Huiying Lin ◽  
Pingting Qiu ◽  
Yu Ye ◽  
...  
Keyword(s):  
Physical Activity ◽  
Older Adults ◽  
Randomised Controlled Trial ◽  
Health Education ◽  
Cognitive Ability ◽  
Cognitive Functions ◽  
Controlled Trial ◽  
Control Group ◽  
Cognitive Frailty ◽  
Randomised Controlled

IntroductionCognitive frailty (CF) is a clinical manifestation characterised by the simultaneous presence of both physical frailty and cognitive impairment among older adults without dementia and has become a new target for healthy ageing. Increasing evidence shows that regular Baduanjin (a traditional Chinese mind–body exercise) training is beneficial in improving physical function and cognitive ability in the older adults. The primary aim of this trial is to observe the effect of Baduanjin on physical and cognitive functions in older adults with CF.Methods and analysisIn this prospective, outcome assessor-blind, two-arm randomised controlled trial, a total of 102 participants with CF will be recruited and randomly allocated (1:1) into the Baduanjin training or usual physical activity control group. The control group will receive health education for 30 min at least once a month. Based on health education, participants in the Baduanjin exercise group will receive a 24-week Baduanjin training with 60 min per session and 3 sessions per week, while those in the usual physical activity control group will maintain their original lifestyle. Primary outcomes (frailty index and global cognitive ability), body composition, grip force, balance, fatigue, specific cognitive domain, including memory, execution and visual spatial abilities, and life quality of secondary outcomes will be measured at baseline, and at 13 and 25 weeks after randomisation, while the structural and functional MRI will be measured at baseline and 25 weeks after randomisation. The mixed linear model will be conducted to observe the intervention effects.Ethics and disseminationThe study has been approved by the ethics committee of the second people’s hospital of Fujian province (Approval no. 2018-KL015). Results will be submitted for publication in peer-reviewed journals and disseminated at scientific conferences.Trial registration numberChiCTR1800020341; Pre-results.

scholarly journals Effectiveness and cost-effectiveness of the PLAN-A intervention, a peer led physical activity program for adolescent girls: results of a cluster randomised controlled trial

2021 ◽  
Vol 18 (1) ◽  
Author(s):  
Russell Jago ◽  
Byron Tibbitts ◽  
Kathryn Willis ◽  
Emily Sanderson ◽  
Rebecca Kandiyali ◽  
...  
Keyword(s):  
Physical Activity ◽  
Cost Effectiveness ◽  
Randomised Controlled Trial ◽  
Primary Outcome ◽  
Controlled Trial ◽  
Cluster Randomised Controlled Trial ◽  
Control Group ◽  
Cluster Randomised ◽  
Secondary Outcomes ◽  
Randomised Controlled

Abstract Background Physical activity is associated with improved health. Girls are less active than boys. Pilot work showed that a peer-led physical activity intervention called PLAN-A was a promising method of increasing physical activity in secondary school age girls. This study examined the effectiveness and cost-effectiveness of the PLAN-A intervention. Methods We conducted a cluster randomised controlled trial with Year 9 (13–14 year old) girls recruited from 20 secondary schools. Schools were randomly assigned to the PLAN-A intervention or a non-intervention control group after baseline data collection. Girls nominated students to be peer leaders. The top 18 % of girls nominated by their peers in intervention schools received three days of training designed to prepare them to support physical activity. Data were collected at two time points, baseline (T0) and 5–6 months post-intervention (T1). Participants wore an accelerometer for seven days to assess the primary outcome of mean weekday minutes of moderate-to-vigorous physical activity (MVPA). Multivariable mixed effects linear regression was used to estimate differences in the primary outcome between the two arms on an Intention-to-Treat (ITT) basis. Resource use and quality of life were measured and a within trial economic evaluation from a public sector perspective was conducted. Results A total of 1558 girls were recruited to the study. At T0, girls in both arms engaged in an average of 51 min of MVPA per weekday. The adjusted mean difference in weekday MVPA at T1 was − 2.84 min per day (95 % CI = -5.94 to 0.25) indicating a slightly larger decline in weekday MVPA in the intervention group. Results were broadly consistent when repeated using a multiple imputation approach and for pre-specified secondary outcomes and sub-groups. The mean cost of the PLAN-A intervention was £2817 per school, equivalent to £31 per girl. Economic analyses indicated that PLAN-A did not lead to demonstrable cost-effectiveness in terms of cost per unit change in QALY. Conclusions This study has shown that the PLAN-A intervention did not result in higher levels of weekday MVPA or associated secondary outcomes among Year 9 girls. The PLAN-A intervention should not be disseminated as a public health strategy. Trial registration ISRCTN14539759–31 May, 2018.

scholarly journals Mii-vitaliSe: a pilot randomised controlled trial of a home gaming system (Nintendo Wii) to increase activity levels, vitality and well-being in people with multiple sclerosis

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e016966 ◽  
Author(s):  
Sarah Thomas ◽  
Louise Fazakarley ◽  
Peter W Thomas ◽  
Sarah Collyer ◽  
Sarah Brenton ◽  
...  
Keyword(s):  
Physical Activity ◽  
Multiple Sclerosis ◽  
Controlled Trial ◽  
Well Being ◽  
Recruitment Rate ◽  
Controlled Study ◽  
Activity Levels ◽  
Nintendo Wii ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectivesWhile the health and well-being benefits of physical activity are recognised, people with multiple sclerosis (MS) often face greater barriers than the general population. The Nintendo Wii potentially offers a fun, convenient way of overcoming some of these. The aim was to test the feasibility of conducting a definitive trial of the effectiveness and cost-effectiveness of Mii-vitaliSe; a home-based, physiotherapist-supported Nintendo Wii intervention.DesignA single-centre wait-list randomised controlled study.SettingMS service in secondary care.ParticipantsAmbulatory, relatively inactive people with clinically confirmed MS.InterventionThirty participants were randomised to receive Mii-vitaliSe either immediately (for 12 months) or after a 6-month wait (for 6 months). Mii-vitaliSe consisted of two supervised Nintendo Wii familiarisation sessions in the hospital followed by home use (Wii Sports, Sports Resort and Fit Plus software) with physiotherapist support and personalised resources.OutcomesIncluded self-reported physical activity levels, quality of life, mood, self-efficacy, fatigue and assessments of balance, gait, mobility and hand dexterity at baseline, 6 and 12 months. Interviews (n=25) explored participants’ experiences and, at study end, the two Mii-vitaliSe facilitators’ experiences of intervention delivery (main qualitative findings reported separately).ResultsMean (SD) age was 49.3 (8.7) years, 90% female, with 47% diagnosed with MS <6 years ago and 60% new to active gaming. The recruitment rate was 31% (95% CI 20% to 44%). Outcome data were available for 29 (97%) at 6 months and 28 (93%) at 12 months. No serious adverse events were reported during the study. Qualitative data indicated that Mii-vitaliSe was well-received. Mean Wii use across both groups over the initial 6-month intervention period was twice a week for 27 min/day. Mean cost of delivering Mii-vitaliSe was £684 per person.DiscussionMii-vitaliSe appears acceptable and a future trial feasible and warranted. These findings will inform its design.Trial registrationISRCTN49286846

scholarly journals Getting Moving Together; a field experiment on workplace physical activity

2021 ◽  
Author(s):  
Michael Sanders ◽  
Karen Tindall ◽  
Alex Gyani ◽  
Susannah Hume ◽  
Min-Taec Kim ◽  
...  
Keyword(s):  
Physical Activity ◽  
Social Comparison ◽  
Comparison Group ◽  
Controlled Trial ◽  
Wearable Devices ◽  
Control Group ◽  
Activity Levels ◽  
Additional Information ◽  
Baseline Activity ◽  
The Social

Importance: Wearable devices are widely used in an effort to increase physical activity and consequently to improve health. The evidence for this is patchy, and it does not appear that wearables alone are sufficient to achieve this end.Objective: To determine whether social comparisons in a workplace setting can increase the effectiveness of wearables at promoting physical activity.Design: A four week randomized controlled trial conducted in November 2015 with employees of a large firm. Participants were randomised to one of two treatment conditions (control vs social comparison) at team level, and teams are formed into ‘leagues’ based on their activity levels before the study. Impact is measured through wearable devices issued to all participants throughout the study duration.Setting: Offices of a large Australian employer.Participants: 646 employees of an Australian employer, issued with wearable activity trackers prior to the beginning of the study. Intervention(s) (for clinical trials) or Exposure(s) (for observational studies). Participants used a wearable device to track steps. Participants had been wearing these for at least four weeks at the outset of the trial, establishing a baseline level of activity. Teams (n=646, k=49), were randomly assigned to either control (k=24), or a social comparison (k=25) treatment. All participants took part in a step-count competition between their team and others at their employer, in which their team’s ranking within a mini-league of five teams, as well as their own activity was communicated each week. The control group had access to the usual features of the wearable, while the social comparison group received additional information about the performance of the other teams in their league, including how far behind and ahead their nearest rival teams were.Main Outcome(s) and Measure(s): Number of steps taken per day on average, measured by the wearable devices issued to all participants. Results: A total of 646 participants were included in the study. Compared to the control, participants in the social comparison group took significantly more steps per day during the trial period (an additional 620 steps, 8.2%, p&lt;0.001). These effects are largest in both relative and absolute terms for people whose prior steps were in the bottom quartile of steps (an additional 948 steps, 40%, p&lt;0.001), while the effect on people with highest levels of activity was a precisely estimated null (an additional 6 steps, 0.01%, p=0.98).Conclusions and Relevance: Social comparison increased the effectiveness of wearables at improving physical activity, particularly for those with the lowest baseline activity.

scholarly journals Community-based rehabilitation training after stroke: results of a pilot randomised controlled trial (ReTrain) investigating acceptability and feasibility

BMJ Open ◽  
2018 ◽  
Vol 8 (2) ◽  
pp. e018409 ◽  
Author(s):  
Sarah G Dean ◽  
Leon Poltawski ◽  
Anne Forster ◽  
Rod S Taylor ◽  
Anne Spencer ◽  
...  
Keyword(s):  
Physical Activity ◽  
Randomised Controlled Trial ◽  
Controlled Trial ◽  
Cognitive Capacity ◽  
Economic Evaluations ◽  
Control Group ◽  
Rehabilitation Training ◽  
One To One ◽  
Randomised Controlled

ObjectivesTo assess acceptability and feasibility of trial processes and the Rehabilitation Training (ReTrain) intervention including an assessment of intervention fidelity.DesignA two-group, assessor-blinded, randomised controlled trial with parallel mixed methods process and economic evaluations.SettingCommunity settings across two sites in Devon.ParticipantsEligible participants were: 18 years old or over, with a diagnosis of stroke and with self-reported mobility issues, no contraindications to physical activity, discharged from National Health Service or any other formal rehabilitation programme at least 1 month before, willing to be randomised to either control or ReTrain and attend the training venue, possessing cognitive capacity and communication ability sufficient to participate. Participants were individually randomised (1:1) via a computer-generated randomisation sequence minimised for time since stroke and level of functional disability. Only outcome assessors independent of the research team were blinded to group allocation.InterventionsReTrain comprised (1) an introductory one-to-one session; (2) ten, twice-weekly group classes with up to two trainers and eight clients; (3) a closing one-to-one session, followed by three drop-in sessions over the subsequent 3 months. Participants received a bespoke home-based training programme. All participants received treatment as usual. The control group received an exercise after stroke advice booklet.Outcome measuresCandidate primary outcomes included functional mobility and physical activity.ResultsForty-five participants were randomised (ReTrain=23; Control=22); data were available from 40 participants at 6 months of follow-up (ReTrain=21; Control=19) and 41 at 9 months of follow-up (ReTrain=21; Control=20). We demonstrated ability to recruit and retain participants. Participants were not burdened by the requirements of the study. We were able to calculate sample estimates for candidate primary outcomes and test procedures for process and health economic evaluations.ConclusionsAll objectives were fulfilled and indicated that a definitive trial of ReTrain is feasible and acceptable.Trial registration numberNCT02429180; Results.

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