Dataset Information

Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study.

ABSTRACT:

Objectives

Gradual age-related cognitive deteriorations are common and are hypothesised to be partially attributable to declines in information-processing speed. The Iowa Healthy and Active Minds Study will evaluate the efficacy and effectiveness of a computerised visual processing speed training programme (Road Tour, Posit Science Corporation, San Francisco, California).

Methods and analysis

Using a 3:3:4:4 ratio within two age strata (50-64 vs ? 65 years old), 681 men and women attending family care clinics were randomised to four treatment groups: 10 h of on-site Road Tour training, 10 h of on-site Road Tour training with 4 h of booster training at 11 months postrandomisation, 10 h of on-site attention control using computerised crossword puzzles (Boatload of Crosswords, Boatload Puzzles, LLC, Yorktown Heights, New York) and 10 h of at-home Road Tour training using the participant's personal computer. The primary outcome, visual processing speed, was assessed at randomisation and post-training (6-8 weeks postrandomisation), and is being reassessed at 1-year postrandomisation using the Useful Field of View test. Five secondary outcomes (Symbol Digit Modalities Test, Trail Making Tests A and B, Controlled Oral Word Association Test, Digit Vigilance Test, and the Stroop Colour and Word Test) were assessed at randomisation and will be reassessed at 1-year postrandomisation. Seven hypotheses will be tested using intent-to-treat analyses involving multiple linear, logistic, Poisson and negative binomial regression.

Ethics and dissemination

Ethics approval was provided by the University of Iowa Institutional Review Board (IRB-03 protocol 200908789). All participants completed signed informed consent prior to enrollment. Road Tour is commercially available from Posit Science Corporation, which provided it to Iowa Healthy and Active Minds Study at no cost. All participants will receive a free copy of Road Tour for unlimited perpetual use at study completion. Clinical Trial Registration Number NCT01165463.

SUBMITTER: Wolinsky FD

PROVIDER: S-EPMC3191599 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Publications

Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study.

Wolinsky Fredric D FD Vander Weg Mark W MW Howren M Bryant MB Jones Michael P MP Martin Rene R Luger Tana M TM Duff Kevin K Goerdt Christopher C Wolfe Steven S Dotson Megan M MM

BMJ open 20110101 2

<h4>Objectives</h4>Gradual age-related cognitive deteriorations are common and are hypothesised to be partially attributable to declines in information-processing speed. The Iowa Healthy and Active Minds Study will evaluate the efficacy and effectiveness of a computerised visual processing speed training programme (Road Tour, Posit Science Corporation, San Francisco, California).<h4>Methods and analysis</h4>Using a 3:3:4:4 ratio within two age strata (50-64 vs ≥ 65 years old), 681 men and women ...[more]

PMID: 22021885

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Project description:Objectives The Iowa Healthy and Active Minds Study is a four-arm randomised controlled trial of a visual processing speed training programme (Road Tour). This article presents the preplanned interim results immediately after training (6-8 weeks post-randomisation) for the primary outcome. Design Within two age strata (50-64 vs ?65), 681 men and women attending general internal and family medicine clinics were randomised to four training groups: (1) supervised, on-site standard (10 h) dose of Road Tour training; (2) supervised, on-site standard dose of Road Tour training with 4 h of subsequent booster training scheduled to occur at 11 months post-randomisation (ie, no booster training had occurred at the time of this interim analysis); (3) supervised, on-site standard dose of attention control (crossword puzzles) training and (4) self-administered, at-home standard dose of Road Tour training. The primary outcome was the Useful Field of View (UFOV) test. Three intent-to-treat interim analyses were conducted, including (1) multiple linear regression models of composite UFOV scores using Blom rank transformations, (2) general linear mixed effects models and (3) multiple logistic regression models among the 620 participants (91%) with complete data. Results In the linear regression analyses of both age strata, random assignment to any Road Tour training group versus the attention control group was significant (p<0.001), with an effect size of -0.558 (adjusted for the Blom rank transformed UFOV score at randomisation). Similar results were obtained for each Road Tour group and within each age stratum and from the general linear and logistic regression models. Conclusions Assignment to a standard dose of Road Tour training yielded medium-sized post-training improvements in visual processing speed. Road Tour was equally effective whether administered under laboratory supervision or self-administered in the patient's home and for participants in both age strata (50-64 vs ?65). Clinical trial registration number NCT01165463.

Project description:Declining cognitive function is relatively common and increasingly prevalent. Studies have shown that different nutrients (e.g., Ginkgo biloba and vitamin E) appear to be effective at improving memory and concentration, while less is known about their effect on immunity.This study investigated the effect of Ginkgo Synergy(®) plus Choline (n = 33) and OPC Synergy(®) plus Catalyn(®) (n = 31) versus placebo (n = 33) in a 6-month, randomized, double-blind trial on cognitive and immune functioning among English-speaking, non-smoking, healthy older adults. The Stroop Color and Word Test, Trail Making Test A and B, Controlled Oral Word Association, Hopkins Verbal Learning, Mini-Mental State Exam, and Digit Symbol were administered at baseline and 3 and 6 months follow-up to assess cognitive functioning. Cytokines and growth factors were measured at baseline and 6 months to assess inflammation and immune functioning. Data were analyzed with linear mixed modeling.No serious adverse events were noted in this study. According to time on the Trail Making Test-B, the Ginkgo Synergy(®) plus Choline arm showed improvement from baseline to 3 months follow-up (mean difference = 24.2; SE = 6.4; 95% CI: 8.6, 39.7; p = 0.01). On the Controlled Oral Word Association Trial-S, the scores significantly increased for the Ginkgo Synergy(®) plus Choline arm from baseline to 6 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 3.9; p < 0.05) and for the OPC Synergy(®) plus Catalyn(®) arm from baseline to 3 months follow-up (mean difference = 2.1; SE = 0.8; 95% CI: 0.2, 4.0; p < 0.05). Epidermal growth factor significantly decreased from baseline to 6 months follow-up for the Ginkgo Synergy(®) plus Choline arm (mean difference = 120.7; SE = 28.4; 95% CI: 62.6, 178.8; p < 0.001).Our study showed isolated and modest effects of a Ginkgo biloba plus choline-based formula on cognitive and immune functioning among healthy older adults with no history of significant cognitive deficits. Our trial was registered with clinicaltrials.gov (ID: NCT01672359). This study was supported by a grant from Standard Process, Inc.

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Project description:As aging is associated with cognitive decline, particularly in the executive functions, it is essential to effectively improve cognition in older adults. Online cognitive training is currently a popular, though controversial method. Although some changes seem possible in older adults through training, far transfer, and longitudinal maintenance are rarely seen. Based on previous literature we created a unique, state-of-the-art intervention study by incorporating frequent sessions and flexible, novel, adaptive training tasks, along with an active control group. We created a program called TAPASS (Training Project Amsterdam Seniors and Stroke), a randomized controlled trial. Healthy older adults (60-80 y.o.) were assigned to a frequent- (FS) or infrequent switching (IS) experimental condition or to the active control group and performed 58 half-hour sessions over the course of 12 weeks. Effects on executive functioning, processing- and psychomotor speed, planning, verbal long term memory, verbal fluency, and reasoning were measured on four time points before, during and after the training. Additionally, we examined the explorative question which individual aspects added to training benefit. Besides improvements on the training, we found significant time effects on multiple transfer tasks in all three groups that likely reflected retest effects. No training-specific improvements were detected, and we did not find evidence of additional benefits of individual characteristics. Judging from these results, the therapeutic value of using commercially available training games to train the aging brain is modest, though any apparent effects should be ascribed more to expectancy and motivation than to the elements in our training protocol. Our results emphasize the importance of using parallel tests as outcome measures for transfer and including both active and passive control conditions. Further investigation into different training methods is advised, including stimulating social interaction and the use of more variable, novel, group-based yet individual-adjusted exercises.

Project description:BackgroundSleep disturbance in older people is an important health issue that is associated with many other health problems. Effective interventions are required to address sleep problems in this group. Acupressure has been suggested as a potential therapeutic technique to improve sleep. The aim of this study is to evaluate the effects of an acupressure intervention on sleep quality, anxiety, depression, and quality of life among older persons in residential aged care facilities within an Australian context.Methods/designThis is a randomised controlled trial with two parallel groups in a pre- and post-test study. Study participants will be older people living in residential aged care facilities. They will be assigned to intervention and control groups using computer-generated random numbers. The intervention group will receive 12-min acupressure three times per week for four consecutive weeks, applied on three acupoints: HT7, PC6, and SP6. The control group will receive only routine care. The primary outcome measure is sleep quality, and secondary outcomes include anxiety, depression, and quality of life. Data will be collected before the intervention, immediately after the end of the intervention, and 2 weeks after the intervention.DiscussionThis study targets a poorly met healthcare need of older people who are experiencing sleep disturbance and its negative consequences. To the researchers' knowledge, this is the first study evaluating acupressure in an Australian aged care context, using specific acupoints and a standardised acupressure protocol. If the results show positive outcomes, acupressure could be used to manage sleep disturbances for older people in the Australian context as well as in the global ageing population. This will contribute to reducing negative consequences of sleep disturbance and use of sleep medications.Trial registrationAustralian New Zealand Clinical Trials Registry: ACTRN12619000262101. Registered on 20 February 2019.

Dataset Information

Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study.

Objectives

Methods and analysis

Ethics and dissemination

Publications

Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study.

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