Evidence map›Paper›PMID 30606137›Full record

Trial reportBMC cancer2019

A phase II randomized controlled trial of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.

Shabbir M H Alibhai, Daniel Santa Mina, Paul Ritvo, George Tomlinson, Catherine Sabiston, Murray Krahn, Sara Durbano, Andrew Matthew, Padraig Warde, Meagan O'Neill and 3 more

Registry-linked trialAbstract readClinical Trial, Phase IIRandomized Controlled TrialEquivalence Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in BMC cancer, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02046837 (A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT), which is not on this map. Cited by 27 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 9 pooled it
–field-weighted citation impact
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.

NCT02046837 phase2completednot on this map

A Pilot RCT and Economic Analysis of Three Exercise Delivery Methods in Men With Prostate Cancer on ADT

TypeinterventionalSponsorUniversity Health Network, TorontoRan2013 to 2018Enrolled59ConditionsProstate CancerArmsSupervised 1:1 exercise, Supervised group exercise, Home-based exercise
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 9 syntheses or guidelines pooled it.

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  3. Inclusivity in prostate cancer and exercise research: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2024
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  7. Physical exercise for bone health in men with prostate cancer receiving androgen deprivation therapy: a systematic review.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2021
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  10. Factors predicting gains in moderate-to-vigorous physical activity in prostate cancer survivors on androgen deprivation therapy.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2022
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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

13 authors.

Shabbir M H AlibhaiUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada. shabbir.alibhai@uhn.ca.ORCID http://orcid.org/0000-0001-7815-6046
Daniel Santa MinaUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Paul RitvoCancer Care Ontario, York University, Toronto, ON, M3J 1P3, Canada.
George TomlinsonUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Catherine SabistonUniversity of Toronto, Toronto, ON, M5S 2J7, Canada.
Murray KrahnUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Sara DurbanoUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Andrew MatthewUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Padraig WardeUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Meagan O'NeillUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Narhari TimilshinaUniversity Health Network, University of Toronto, Toronto, ON, M5G 2C4, Canada.
Roanne SegalThe Ottawa Hospital Cancer Centre, University of Ottawa, Ottawa, ON, K1N 6N5, Canada.
Nicole Culos-ReedUniversity of Calgary, Calgary, AB, T2N 1N4, Canada.

Funding

Prostate Cancer Canada D2013-1
6 · The paper itself

Abstract

backgroundExisting evidence demonstrates that 1:1 personal training (PT) improves many adverse effects of androgen deprivation therapy (ADT). Whether less resource-intensive exercise delivery models are as effective remains to be established. We determined the feasibility of conducting a multi-center non-inferiority randomized controlled trial comparing PT with supervised group (GROUP) and home-based (HOME) exercise programs, and obtained preliminary efficacy estimates for GROUP and HOME compared to PT on quality of life (QOL) and physical fitness.

methodsMen with prostate cancer on ADT were recruited from one of two experienced Canadian centres and randomized 1:1:1 to PT, GROUP, or HOME. Randomization was stratified by length of ADT use and site. Participants completed moderate intensity aerobic and resistance exercises 4-5 days per week for 6 months with a target 150 min per week of exercise. Exercise prescriptions were individualized and progressed throughout the trial. Feasibility endpoints included recruitment, retention, adherence, and participant satisfaction. The efficacy endpoints QOL, fatigue, and fitness (VO2 peak, grip strength, and timed chair stands) in GROUP and HOME were compared for non-inferiority to PT. Descriptive analyses were used for feasibility endpoints. Between-group differences for efficacy endpoints were examined using Bayesian linear mixed effects models.

resultsFifty-nine participants (mean age 69.9 years) were enrolled. The recruitment rate was 25.4% and recruitment was slower than projected. Retention was 71.2%. Exercise adherence as measured through attendance was high for supervised sessions but under 50% by self-report and accelerometry. Satisfaction was high and there was no difference in this measure between all three groups. Between-group differences (comparing both GROUP and HOME to PT) were smaller than the minimum clinically important difference on most measures of QOL, fatigue, and fitness. However, two of six outcomes for GROUP and four of six outcomes for HOME had a > 20% probability of being inferior for GROUP.

conclusionsFeasibility endpoints were generally met. Both GROUP and HOME interventions in men with PC on ADT appeared to be similar to PT for multiple efficacy outcomes, although conclusions are limited by a small sample size and cost considerations have not been incorporated. Efforts need to be targeted to improving recruitment and adherence. A larger trial is warranted.

trial registrationClinicalTrials.gov: NCT02046837 . Date of registration: January 20, 2014.

Indexed as

Exercise TherapyPhysical FitnessAgedAndrogen AntagonistsAntineoplastic Agents, HormonalCanadaExerciseHumansMaleMiddle AgedMuscle StrengthProstatic NeoplasmsQuality of LifeSelf ReportAndrogen AntagonistsAntineoplastic Agents, HormonalAndrogen deprivation therapyCost-effectivenessExerciseFatiguePatient adherencePhysical fitnessProstate cancerQuality of lifeRandomized controlled trial

Identifiers

PMID30606137
PMCPMC6318980

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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.