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Randomized Controlled Trial
. 2016 Oct 10;11(10):e0164246.
doi: 10.1371/journal.pone.0164246. eCollection 2016.

Contamination by an Active Control Condition in a Randomized Exercise Trial

Diane K Ehlers  1 , Jason Fanning  1 , Elizabeth A Awick  1 , Arthur F Kramer  2 , Edward McAuley  1
Affiliations
Randomized Controlled Trial

Contamination by an Active Control Condition in a Randomized Exercise Trial

Diane K Ehlers et al. PLoS One. .

Abstract

Contamination is commonly overlooked in randomized trials. The present study examined contamination (minutes of aerobic activity outside of exercise sessions) within an active control condition in a 6-month randomized exercise trial for older adults. We hypothesized that outside aerobic activity would be greater in the control condition compared to the intervention conditions. Participants (mean age = 65.06 years, 66.2% female) were randomly assigned to: Dance (n = 50), Walking, (n = 108), or Strength/Stretching/Stability (SSS; n = 48). Dance and Walking represented the experimental conditions and SSS the control condition. Participants attended exercise sessions three times weekly for 24 weeks. Participants recorded their physical activity outside of class on a weekly home log. Group assignment and covariates (age, gender, body mass index, exercise session intensity and enjoyment, and program adherence) were examined as predictors of weekly aerobic activity outside of exercise sessions. Participants who returned zero home logs were removed from the dataset (final N = 195). Out-of-class aerobic activity was lowest in the Walking group. Significant effects of gender, group, enjoyment, and intensity on out-of-class weekly aerobic activity were observed, all p<0.003. Higher perceived enjoyment of exercise sessions was associated with more out-of-class aerobic activity, while higher perceived intensity was associated with less out-of-class aerobic activity. A group x intensity interaction, p = 0.002, indicated that group differences in out-of-class aerobic activity were evident only among those with lower intensity perceptions. Walkers may have perceived exercise sessions as sufficient weekly exercise, while the Dance and SSS groups may have perceived the sessions as necessary, but insufficient. The lower aerobic intensity Dancers attributed to exercise sessions and non-aerobic nature of SSS may partially explain contamination observed in this study. Further examination of contamination in randomized controlled exercise trials is critically needed.

Trial registration: ClinicalTrials.gov NCT01472744.

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Conflict of interest statement

The authors have declared that no competing interests exist.

Figures

Fig 1
Fig 1. CONSORT Diagram.
Fig 2
Fig 2. Weekly Aerobic Activity Outside of Program Sessions.
Fig 3
Fig 3. Group differences in out-of-class aerobic activity overall and by perceived intensity of exercise sessions.
*Mean unstandardized predicted values (adjusted for gender).
See this image and copyright information in PMC

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