Evidence map›Paper›PMID 21615936›Full record

Trial reportBMC geriatrics2011

Designing clinical trials for assessing the effects of cognitive training and physical activity interventions on cognitive outcomes: the Seniors Health and Activity Research Program Pilot (SHARP-P) study, a randomized controlled trial.

Claudine Legault, Janine M Jennings, Jeffrey A Katula, Dale Dagenbach, Sarah A Gaussoin, Kaycee M Sink, Stephen R Rapp, W Jack Rejeski, Sally A Shumaker, Mark A Espeland and 1 more

Registry-linked trialOpen access · goldAbstract readComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC geriatrics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00688155 (Seniors Health and Activity Research Program-Pilot), which is not on this map. Cited by 68 papers, 23 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
68citing papers in PubMed, 23 pooled it
2.5field-weighted citation impact, top 10% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00688155 nacompletednot on this map

Seniors Health and Activity Research Program-Pilot

TypeinterventionalSponsorWake Forest University Health SciencesRan2008 to 2010Enrolled73ConditionsCognitive FunctionArmsPhysical Activity Training, Cognitive Training, Healthy Aging Education
3 · Its place in the literature

Who cites it

68 citing papers in PubMed, 23 syntheses or guidelines pooled it, 121 citations in OpenAlex.

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8 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 2 institutions in 1 country.

Claudine LegaultDivision of Public Health Sciences, Department of Biostatistical Sciences - Wachovia 21st floor, Medical Center Boulevard, Winston-Salem, North Carolina 27157, USA. clegault@wfubmc.edu
Janine M Jennings
Jeffrey A Katula
Dale Dagenbach
Sarah A Gaussoin
Kaycee M Sink
Stephen R Rapp
W Jack Rejeski
Sally A Shumaker
Mark A Espeland
SHARP-P Study Group
Wake Forest University · USBiostatistical Consulting (United States) · US

Funding

WORKER PROTECTION AGAINST AIRBORNE INFLUENZA - A PILOT STUDYM01RR007122 · NCRR · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI HOLMES, ROSS P · 1992 to 2010
$35.2M
Seniors Health and Activity Research Program Pilot (SHARP-P)R01AG029285 · NIA · WAKE FOREST UNIVERSITY HEALTH SCIENCES · PI ESPELAND, MARK ANDREW · 2007 to 2008
$938k
NCRR NIH HHS M01-RR07122NIA NIH HHS 1R01AG029285 - 01A1
6 · The paper itself

Abstract

backgroundThe efficacy of non-pharmacological intervention approaches such as physical activity, strength, and cognitive training for improving brain health has not been established. Before definitive trials are mounted, important design questions on participation/adherence, training and interventions effects must be answered to more fully inform a full-scale trial.

methodsSHARP-P was a single-blinded randomized controlled pilot trial of a 4-month physical activity training intervention (PA) and/or cognitive training intervention (CT) in a 2 × 2 factorial design with a health education control condition in 73 community-dwelling persons, aged 70-85 years, who were at risk for cognitive decline but did not have mild cognitive impairment.

resultsIntervention attendance rates were higher in the CT and PACT groups: CT: 96%, PA: 76%, PACT: 90% (p=0.004), the interventions produced marked changes in cognitive and physical performance measures (p≤0.05), and retention rates exceeded 90%. There were no statistically significant differences in 4-month changes in composite scores of cognitive, executive, and episodic memory function among arms. Four-month improvements in the composite measure increased with age among participants assigned to physical activity training but decreased with age for other participants (intervention*age interaction p=0.01). Depending on the choice of outcome, two-armed full-scale trials may require fewer than 1,000 participants (continuous outcome) or 2,000 participants (categorical outcome).

conclusionsGood levels of participation, adherence, and retention appear to be achievable for participants through age 85 years. Care should be taken to ensure that an attention control condition does not attenuate intervention effects. Depending on the choice of outcome measures, the necessary sample sizes to conduct four-year trials appear to be feasible.

trial registrationClinicaltrials.gov Identifier: NCT00688155.

Indexed as

LearningMotor ActivityAgedAged, 80 and overCognition DisordersCognitive Behavioral TherapyCohort StudiesHumansPilot ProjectsSingle-Blind MethodTreatment Outcome

Identifiers

PMID21615936
PMCPMC3126708
OpenAlexW1979325947

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.