The REMINDer randomized controlled study: Feasibility and impact of an online multimodal mind-body intervention in older adults

Abstract

Background: The increase in life expectancy and age-related diseases, such as Alzheimer's disease, is a global challenge. Given the drawbacks of pharmacological treatments, it is important to pursue non-pharmacological strategies for dementia risk reduction. To effectively promote health and well-being in later life, multimodal, low-threshold, and cost-effective lifestyle interventions are needed. Methods: REMINDer is a monocentric, outcome assessor-blinded, randomized controlled pilot study to assess the feasibility and impact of a multimodal intervention delivered online (home-based and live-streamed). The 6-week (two one-hour sessions/week) online mind-body group intervention will be compared to a 6-week passive control (waitlist with delayed intervention) using a cross-over (AB-BA) design. The intervention was specifically designed for older adults and includes music, dance-based movement, and mindfulness. A total of N=50 cognitively unimpaired older adults will be enrolled and randomized into the two intervention arms using a block randomization with a 1:1 allocation ratio. Results: Outcomes will be assessed at pre-intervention, post-intervention, and follow-up using digital assessments of online questionnaires. Primary outcomes include feasibility, operationalized by adherence rates, and preliminary effectiveness of the intervention. The latter will be assessed by changes in self-reported mental and physical well-being, operationalized by the Short-Form Health Survey (SF-12). Secondary outcomes will include changes in self-reported health outcomes including cognitive, motor, sensory, emotional/affective, social, and lifestyle behaviors. Discussion: The study will provide evidence of the feasibility and preliminary effectiveness of an online multimodal mind-body intervention. If successful, the study may inform accessible lifestyle strategies to improve mental health and well-being and other risk factors for dementia in older adults. Registration: NCT06530277

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06530277

Funding Statement

This study received funding by the DZNE Stiftung Forschung fuer ein Leben ohne Demenz, Parkinson und ALS (T 0531/36311/2020/kg and T 0531/41814/2002/kg). The funder was not involved in the study design, data acquisition, data analysis, data interpretation or manuscript writing.

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

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

This study was approved by the local Ethics Committee of the Technische Universitaet Dresden, Dresden, Germany.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

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I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

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Data Availability

Anonymized data will be made available to any qualified investigator upon request.

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