Background Limited knowledge exists about individuals who decline participation in exercise trials. This study compared characteristics of participants and nonparticipants in a kidney transplant exercise trial using a dual-consent design.

Methods The study was nested within the PHOENIX-Kidney randomized controlled trial, which evaluated a home-based exercise and physical activity intervention in kidney transplant recipients. At three months post-transplant, eligible individuals were invited to participate via two parallel consent pathways: one for trial participation and one for observational data of nonparticipants. Both groups completed self-reported questionnaires on sociodemographics, physical activity levels, and perceived motivators and barriers to physical activity. Reasons for nonparticipation were documented, and clinical data were extracted from medical records. Group comparisons used t-tests, Mann-Whitney U, chi-square, and Fisher’s exact tests.

Results Of 345 screened kidney transplant recipients, 58% were eligible. Ineligibility was primarily due to medical contraindications (26%), language barriers (24%), and multi-organ transplantation (20%). Among eligible individuals, 88 (44%) enrolled in the intervention and 65 (35%) completed the observational follow-up for nonparticipants. Major reasons for nonparticipation included lack of time (23%), and feeling sufficiently active (20%). Nonparticipants reported higher physical activity levels (195 [120–360] vs. 103 [19–180] minutes per week; P = 0.003), while participants had higher motivator scores for physical activity (2.1 [1.6 – 2.4] vs. 1.5 [1.1 – 1.9]; P < 0.01).

Conclusion The dual-consent approach enabled unique insights into differences between participants and nonparticipants, which can inform strategies to reduce participation bias and enhance inclusivity in future trials.

Clinical Trial Registration Clinicaltrials.gov identifier number: NCT06260579.

The authors have declared no competing interest.

Clinicaltrials.gov identifier number: NCT06260579

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Ethical approval for the PHOENIX-Kidney RCT was obtained from the local ethics committees of Leuven and Ghent University Hospitals (B3222022000937).

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