Methodological and clinical implications of a three-in-one Russian doll design for tracking health trajectories and improving health and function through innovative exercise treatments in adults with disability

James H Rimmer, Cassandra Herman, Brooks Wingo, Kevin Fontaine, Tapan Mehta, James H Rimmer, Cassandra Herman, Brooks Wingo, Kevin Fontaine, Tapan Mehta

Abstract

Background: Hybrid research designs targeting adults with neurologic disability are critical for improving the efficiency of models that can identify, track and intervene on identified health issues.

Methods: Our Russian doll framework encompasses three study phases. Phase 1 involves prospectively following a cohort of participants with disability to examine the relationships between rates of health and functional deficits (e.g., pain, fatigue, deconditioning), functional measures (e.g., cardiorespiratory endurance, strength, balance), and environmental and sociocultural factors. In Phase 2, eligible participants with neurologic disability from Phase 1 (in our example, individuals with multiple sclerosis) are screened and randomized to a clinical exercise efficacy trial. In Phase 3, study participants are enrolled in a home-based teleexercise trial to test the feasibility and replicability of delivering the clinical exercise study in the home.

Discussion: This unique three-in-one Russian doll framework serves as a foundation for informing and guiding researchers and clinicians in treating certain health and functional deficits in people with neurologic disability using exercise as a primary treatment modality in both the clinical and home settings. It offers a unique perspective for understanding the critical issues of functioning, health maintenance and quality of life for people with neurologic disability across a longitudinal framework.

Trial registration: Study 2 ClinicalTrials.gov identifier NCT02533882 (retroactively registered 03/06/2015). Study 3 ClinicalTrials.gov identifier NCT03108950 (retroactively registered 04/05/2017).

Keywords: Exercise; Exercise rehabilitation; Health; Longitudinal; Neurologic disability.

Conflict of interest statement

Ethics approval and consent to participate

This project was approved by the Institutional Review Board of the University of Alabama at Birmingham (protocol numbers F140401002, F140821001, F160404004).

Written informed consent is obtained from every participant prior to enrollment in each phase of the protocol.

Ongoing interventions are currently registered at Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Three-In-One ‘Russian doll’ Study Design. BLADE2S (S1) – Birmingham-Lakeshore Aging with Disability Exercise and Environment Study. LEADERS (S2) – Lakeshore Examination of Activity, Disability and Exercise Response Study. TExT-ME (S3) – Telehealth Exercise Training for Monitoring and Evaluation
Fig. 2
Fig. 2
Example of Participant Flow in Russian doll Study Design. # - All participants in the project will continue to receive two assessments annually. ^ - M2M = Movement to Music. * - WC = Waitlist Control. + − The most effective intervention between M2M and Yoga in S2 will be assigned as the intervention in S3 by disability

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