Clinical trial NCT04095962: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
Official title: Body and Brain: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dementia
Alzheimer Disease
Vascular Dementia
Neurocognitive Disorders
Keywords: Functionality
Multimodal
Cognition
Lead sponsor: Universidade do Porto
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
First posted: 2019-09-19
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Dementia is a leading cause of death and disability that was declared as one of the greatest health and social care challenges of the 21st century. Regular physical activity and exercise have been proposed as a non-pharmacological strategy in disease prevention and management. Multicomponent Training (MT) combines aerobic, strength, balance, and postural exercises and might be an effective training to improve both functional capacity and cognitive function in individuals with dementia (IwD). Nevertheless, data on the effects of MT in IwD are still limited and the extent to which IwD can retain improvements after an exercise intervention still needs to be elucidated. The aim of "Body \& Brain" study is to investigate the effects of a 6-month MT intervention and 3-month detraining on the physical and cognitive function of IwD. Additionally, we aim to explore the impact of this intervention on psychosocial factors and physiologic markers related to dementia.

Detailed description: Although exercise interventions for IwD seem to be feasible and well tolerated, resulting in positive effects on ADL functionality for people at mild-to-moderate stages \[1, 2\], the therapeutic role of physical activity, particularly exercise, after dementia diagnosis still needs further evidence \[3-5\], - especially when considering community-based contexts and caregivers as participants on exercise sessions \[6\]. It also matters to highlight that the dose-dependent relationship remains unclear \[1, 7, 8\]. Therefore, research is needed to identify the triad: stage/type of dementia, FITT variables (frequency, intensity, type, and time) of exercise intervention, and target outcome \[7, 9\]. Regarding exercise modality, Multicomponent Training (MT) \[10\] - combining aerobics, strength and balance exercises - seems to be effective at improving functional and cognitive performances in older adults with neurodegenerative disorders, particularly dementia \[11-13\]. Exercise programs previously developed by our group confirmed that a 6-month MT intervention can positively impact the physical and cognitive function of institutionalized older adults with AD \[14, 15\] and can be beneficial in physical fitness and ADL functionality performance among community-dwelling patients \[9, 16\]. However, the extent to which IwD can retain these improvements after the cessation of MT intervention still need to be elucidated \[17\] in order to understand how detraining affects functionality and cognition following the cessation of MT stimulus.

This study is a quasi-experimental controlled trial using a parallel-group design. The study sample consists of community-dwelling individuals aged ≥ 60 years who are clinically diagnosed with dementia or major neurocognitive disorder. Participants will be either allocated into the intervention group or the control group. The intervention group will participate in MT biweekly exercise sessions, whereas the control group will receive monthly sessions regarding physical activity and health-related topics for 6 months. The main outcomes will be physical function as measured by the Short Physical Performance Battery (SPPB) and cognitive function evaluated using the Alzheimer Disease Assessment Scale - Cognitive (ADAS-Cog) at baseline, after 6-months and 3-months after the end of intervention. Secondary outcomes will be body composition, physical fitness, daily functionality, quality of life, neuropsychiatric symptoms and caregiver's burden. Cardiovascular, inflammatory and neurotrophic blood-based biomarkers, and arterial stiffness will also be evaluated in subsamples.

Eligibility criteria: Inclusion Criteria:

* Individuals aged ≥ 60 years capable of walking autonomously without an assistive device or human assistance;
* Individuals diagnosed with dementia or major neurocognitive disorder using accepted diagnostic criteria such as that established by the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR or DSM-5), ICD-10, or the NINCDS-ADRDA; by a physician for at least for 6-months.

Exclusion Criteria:

* Individuals diagnosed with certain disorders or conditions in which exercise is contraindicated such as unstable or ongoing cardiovascular and/or respiratory disorder;
* Hospitalized individuals and/or recovering from surgery or rehabilitation;
* Individuals presenting an advanced stage of dementia (e.g., scored 3-points in CDR or ≤ 10 points on MMSE) that could affect physical performance in the exercise training sessions or testing procedures.

Primary outcomes:
measure: Change from Baseline on Short Physical Performance Battery (SPBB)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Secondary outcomes:
measure: Change from Baseline on 30-second Chair-stand Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on 30-second Arm Curl Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on 2-minute Step Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on 8-Foot Up and Go Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Back Scratch Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Sit and reach Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Modified Bruce Treadmill Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on One Leg Balance Test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Handgrip test
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Appendicular Skeletal Muscle Mass Index (ASMI)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Body mass, fat-free mass, fat mass
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Barthel Index (BI)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Lawton & Brody (IADL)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Mini-Mental State Examination (MMSE)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Trail-making test (TMT)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Neuropsychiatric inventory (NPI)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Quality of Life in Alzheimer's Disease scale (QoL-AD)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Caregiver subjective burden (CarerQol-7D)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Caregiver subjective well-being (CarerQol-VAS)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Blood triglycerides (TG), total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Circulating levels of Glycated Hemoglobin (HbA1c)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Circulating levels of Interleukin-6 (IL-6),Interleukin-8 (IL-8), Interleukin-10 (IL-10)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Circulating levels of C-Reactive Protein (CRP) and Tumor Necrosis Factor (TNF-alfa)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Circulating levels of free brain-derived neurotrophic factor (BDNF),Vascular Endothelial Growth Factor (VEGF), intercellular adhesion molecule 1 (sICAM-1), vascular cell adhesion molecule-1 (sVCAM-1), metalloproteinase-9 (MMP-9)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Circulating levels of Insulin-like growth factor-1 (IGF-1)
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Systolic and Diastolic Blood Pressure
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
measure: Change from Baseline on Arterial stiffness
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Other outcomes:
measure: Change from Baseline on Daily Physical Activity levels
timeFrame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Locations:
city: Porto
country: Portugal
facility: Faculty of Sports of University of Porto
Study officials:
affiliation: Universidade do Porto
name: Joana Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Borges-Machado F, Barros D, Teixeira L, Ribeiro O, Carvalho J. Contribution of a multicomponent intervention on functional capacity and independence on activities of daily living in individuals with neurocognitive disorder. BMC Geriatr. 2021 Nov 3;21(1):625. doi: 10.1186/s12877-021-02591-2.
citation: Borges-Machado F, Barros D, Teixeira L, Ribeiro O, Carvalho J. Health-related physical indicators and self-rated quality of life in older adults with neurocognitive disorder. Qual Life Res. 2021 Aug;30(8):2255-2264. doi: 10.1007/s11136-021-02828-y. Epub 2021 Mar 28.
citation: Carvalho J, Borges-Machado F, Barros D, Sampaio A, Marques-Aleixo I, Bohn L, Pizarro A, Teixeira L, Magalhaes J, Ribeiro O. "Body & Brain": effects of a multicomponent exercise intervention on physical and cognitive function of adults with dementia - study protocol for a quasi-experimental controlled trial. BMC Geriatr. 2021 Mar 4;21(1):156. doi: 10.1186/s12877-021-02104-1.
citation: Sampaio A, Marques-Aleixo I, Seabra A, Mota J, Carvalho J. Physical exercise for individuals with dementia: potential benefits perceived by formal caregivers. BMC Geriatr. 2021 Jan 6;21(1):6. doi: 10.1186/s12877-020-01938-5.