Clinical trial NCT06722976: Digital Health and Exercise for Autonomous Longevity Program
Official title: Digital HEAL (Health and Exercise for Autonomous Longevity)
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Mild Cognitive Impairment (MCI)
Older People
Lead sponsor: University of Beira Interior
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.

The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.

1. Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
2. Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
3. Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).

Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\&#39; maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.

Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.

Detailed description: Digital HEAL (Health and Exercise for Autonomous Longevity) is a multicomponent training program (combining concurrent training with cognitive stimulation) designed to promote physical fitness and cognitive function in older adults. This program merges a community-based approach with a scientific research project aimed at comparing the effects of in-person and online concurrent training on cognitive function and functional capacity in this population.

The program is developed and implemented by the Department of Sports Sciences, the Faculty of Health Sciences, and the Department of Psychology and Education of the University of Beira Interior (UBI), in collaboration with the University of Turin. The principal investigator is Ricardo André Alves Bispo Madeira.

The program is structured into three phases: (1) Initial Assessment; (2) Multicomponent Training Sessions; (3) Final Assessment.

1. Initial Assessment The initial assessment will consist of physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).
2. Multicomponent Training Sessions The multicomponent training sessions will last for 3 months, with a frequency of two sessions per week, each lasting 50 minutes, conducted in person at the institution.
3. Final Assessment The final assessment will be identical to the initial assessment, comprising physical fitness tests (approximately 1 hour) and Neuropsychological Evaluation tests (approximately 1.5 hours).

Expected Benefits The anticipated benefits for participants include significant improvements in physical fitness, with a particular emphasis on strength, balance, and motor autonomy, which play an essential role in fall prevention. Additionally, cognitive abilities such as orientation, memory, and brain plasticity are expected to improve. The program also aims to promote social interaction, reducing social isolation among older adults. Furthermore, the program will support participants\&#39; maintenance within the institution, which helps preserve their routine and address mobility and accessibility limitations. This intervention will also help reduce costs and time for the institution.

Potential Risks The risks associated with participation in the program are similar to those inherent in any physical activity. However, the equipment and environment (floor type, lighting, temperature) are evaluated to ensure suitability for safe exercise at any age. The exercises are supervised by a qualified professional who takes special care to minimize exercise-related risks.

Voluntary Participation and Confidentiality Participation in the program is entirely voluntary, and participants can withdraw at any time without any consequences. Confidentiality is guaranteed, with only the principal investigator, Ricardo André Alves Bispo Madeira, having access to personal data, which will always be coded and not disclosed. The collected data will be used strictly for academic purposes, with no commercial interests. Upon request, individual data can be provided to each participant, improving the assessment of their current condition.

Research Team

The team of researchers involved includes:

Dr. Maria da Assunção Vaz Patto (Associate Professor at the Faculty of Health Sciences, UBI, and researcher at the Health Sciences Research Center - CICS-UBI) Dr. Maria Dulce Leal Esteves (Lecturer in the Department of Sports Sciences and researcher at the Research Center for Sport, Health, and Human Development - CIDESD) Dr. Nuno Filipe Cardoso Pinto (Adjunct Assistant Professor at the Faculty of Health Sciences, UBI, and researcher at CICS-UBI) Ricardo André Alves Bispo Madeira (Ph.D. student in Sports Sciences)

Principal Investigator Signature

By signing this document, I confirm, on behalf of the research team, that I have conveyed all the information contained herein, explained it, and answered all questions and concerns raised by the participant and their family members.

Eligibility criteria: Inclusion Criteria:

* Male and female participants aged ≥ 65 years.
* A score of ≥ 3 on the Short Physical Performance Battery (SPPB).
* Willingness to participate in the training programs and collaborate with the research team.

Ability to provide informed consent, either oral or written.

Exclusion Criteria:

* A score of ≤ 3 on the Short Physical Performance Battery (SPPB).
* Presence of severe comorbidities that would negatively impact participation in the training program.
* Presence of color blindness.
* Diagnosis of severe dementia or severe impairment across multiple dimensions of cognition, which would prevent participation in the training program.
* History of surgeries or fractures within the last 6 months.

These criteria ensure that participants are suitable for the program and capable of engaging in the training sessions effectively.

Primary outcomes:
measure: Speed, agility and dynamic balance
timeFrame: 3 months
measure: Speed, agility and dynamic balance
timeFrame: 3 months
measure: Strength assessment
timeFrame: 3 months
measure: Strength assessment
timeFrame: 3 months
measure: Strength assessment
timeFrame: 3 months
measure: Strength assessment
timeFrame: 3 months
measure: Flexibility assessment
timeFrame: 3 months
measure: Flexibility assessment
timeFrame: 3 months
measure: Cognitive assessment
timeFrame: 3 months
measure: Salivary assessment
timeFrame: 3 months
measure: Salivary assessment
timeFrame: 3 months
measure: Body Composition Assessment
timeFrame: 3 months
measure: Body Composition Assessment
timeFrame: 3 months
measure: Assessment of memory, concentration, attention and executive cognitive functions
timeFrame: 3 months
measure: Assessment of memory, concentration, attention and executive cognitive functions
timeFrame: 3 months
measure: Quality of Life
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Covilhã
country: Portugal
facility: Departement of Sports Science
Study officials:
affiliation: University of Beira Interior
name: Dulce Esteves, PhD
role: STUDY_DIRECTOR
References:
citation: Hu JP, Guo YH, Wang F, Zhao XP, Zhang QH, Song QH. Exercise improves cognitive function in aging patients. Int J Clin Exp Med. 2014 Oct 15;7(10):3144-9. eCollection 2014.
citation: Janson P, Willeke K, Zaibert L, Budnick A, Berghofer A, Kittel-Schneider S, Heuschmann PU, Zapf A, Wildner M, Stupp C, Keil T. Mortality, Morbidity and Health-Related Outcomes in Informal Caregivers Compared to Non-Caregivers: A Systematic Review. Int J Environ Res Public Health. 2022 May 11;19(10):5864. doi: 10.3390/ijerph19105864.
citation: Tokovska M, Nour MM, Sorensen A, Smaland Goth U. Informal caregivers and psychosocial support: Analysis of European Dementia Policy documents. J Public Health Res. 2021 Sep 27;11(1):2416. doi: 10.4081/jphr.2021.2416.