DementiaBody&BrainNCT04095962
Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
A study testing Exercise in people with Dementia and Alzheimer Disease, run by Universidade do Porto at 1 site in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Vascular Dementia
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePortugal
- Study dates
- 1 Sep 2018to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Portugal1 site, 1 recruiting
- Recruiting
Faculty of Sports of University of Porto
Porto, 4200
Joana Carvalho, PhD, +351220425316
Joana Carvalho, PhD
About this study
Official title: Body and Brain: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
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.
Read the 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.
- Being tested
- Exercise
- Keywords
- Functionality, Multimodal, Cognition
- Medical subject headings
- Dementia, Alzheimer Disease, Dementia, Vascular, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Multicomponent training
The MT program will be conducted for 6 months, twice a week in 60 minutes sessions. Sessions will be divided in warm-up (10 minutes, including slow walk, postural and mobility exercises for general activation, and stretching exercises), specific training (35-45 minutes, including balance/coordination training, strength and aerobic exercises) and cool down (5 minutes with breathing and stretching exercises for the main worked joints and muscles) following the main guidelines recommended by the American College of Sports Medicine [18] and the WHO [19].
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Training protocol will be held for 6 months, twice per week/ 60 min per sessions. Receives: Other: Exercise |
| Control Group | No intervention | Participants in the control group will receive monthly sessions regarding physical activity and health related topics as a complement to standard care. No specific exercise intervention will be conducted for this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline on Short Physical Performance Battery (SPBB)
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
To evaluate cognitive function with a total scoring ranging between 0 - 68. A score of 68 represents the most severe impairment and 0 represents the least impairment.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Secondary outcomes (27)
Change from Baseline on 30-second Chair-stand Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
Lower body strength was measured using the 30 s chair stand test. Participants were asked to sit in a 43-cm armless chair with their arms crossed at the wrists and held against the chest. The score was the total number of stands executed correctly within 30 s.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 30-second Arm Curl Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
Upper body strength was assessed using the arm curl test. Participants performed as many biceps curls as possible in 30 s, using a dumbbell (3.63 kg and 2.27 kg for men and women, respectively). The score was the total number of hand-weight curls performed through the full range of motion within 30 s.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 2-minute Step Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
Cardiorespiratory fitness was measured using 2-min step test. Participants were asked to raise each knee to a point midway between the patella (kneecap) and iliac crest (top hip bone). The score was the number of times the right knee reaches the required height.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 8-Foot Up and Go Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
Participants were asked to as quickly as possible, in a sitting position, stand up, walk 8-foot distance (2,44 meters), turn the cone marker around and return to the seated position. The time, in seconds, necessary to complete this test was registered.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Back Scratch Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
Upper-body flexibility was measured through the back-scratch test. The participants were asked to, in standing position, place the preferred hand over the same shoulder, reaching down the middle of the back as far as possible - elbow pointed up. Then, the participants were asked to place the other arm around the back of the waist with the palm up and in attempt to touch (or overlap) the extended middle fingers of both hands. The nearest distance (in centimeters) was measured between the tips of the middle fingers (minus or plus, depending if overlapping or not)
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Sit and reach Test
Physical fitness is going to be measured via the Senior Fitness Test (SFT).This physical battery includes lower and upper-body strength (30-second chair stand and 30-second arm curl tests, respectively), lower and upper-body flexibility (chair sit-and-reach and back scratch tests, respectively), aerobic endurance (2-minute step test), and agility/dynamic balance (8-foot up-and-go test).
The chair sit-and-reach test was used to assess lower-body flexibility. Participants were asked to sit at the front edge of a chair and with one leg extended (dominant) reach the toward toes as far as possible, bending the upper body forward at the hip joint. The other leg must be bent and slightly off to one side with the foot flat on the floor. The number of centimeters (plus or minus) were registered between the extended fingers (hands overlapping) and the tip of the toe - maintaining the position for at least 2 seconds.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Modified Bruce Treadmill Test
This sub-maximal test with incremental protocol including seven stages and performed on a treadmill. To assess Peak oxygen uptake (VO2 peak), standard an open-circuit spirometer technique (Cosmed K4b2, Cosmed, Rome, Italy) will be used.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on One Leg Balance Test
The static balance will be measured with the One Leg Balance Test. Participants will be asked to choose a leg to stand on, flex the opposite knee and balance on one leg as long as possible. The time (in seconds) standing unsupported will be recorded.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Handgrip test
Handgrip strength will be obtained with a Jamar Plus + Digital hand dynamometer (Sammons Preston Inc., Bolingbrook, Illinois, USA).Measurements will be carried out following the American Society of Hand Therapists recommendations, and each participant will perform three attempts with a pause of 1 min between them. The maximum value, in kilograms of force (kgf), of the three measurements with the dominant hand will be registered.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Appendicular Skeletal Muscle Mass Index (ASMI)
Appendicular Skeletal Muscle Mass Index (ASMI), which is the sum of muscle masses of the four limbs described as appendicular skeletal muscle mass adjusted for height (kg/m2), will be analyzed with Dual Energy X-ray Absorptiometry (DXA) (Hologic QDR 4500, Explorer model, version 12.4).
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Body mass, fat-free mass, fat mass
Body mass (kg), fat-free mass (kg) and fact mass (kg) will be analyzed with Dual Energy X-ray Absorptiometry (DXA) (Hologic QDR 4500, Explorer model, version 12.4)
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Barthel Index (BI)
To evaluate independence on performing basic activities of daily living, ranging from 0-100 and with higher scores representing increased functionality.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Lawton & Brody (IADL)
Assessment of instrumental activities of daily life. It evaluates the following categories and subcategories: A. Ability to Use Telephone; B. Shopping; C.Food Preparation; D.Housekeeping; E. Laundry; F. Mode of Transportation; G. Responsibility for Own Medications; H. Ability to Handle Finances. Range 0-8. Lower scores are indicative of increased difficulties to independently perform instrumental activities.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Mini-Mental State Examination (MMSE)
The Mini Mental State Examination (MMSE) a widely used test of cognitive function among older adults will be used and consists of a 30-item instrument (with higher scores indicating better cognitive performance) that is organized in six cognitive domains - orientation, retention, attention and calculation, delayed recall, language, and visuo-constructive ability.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Trail-making test (TMT)
The executive functions will be assessed with the Trail Making Test part A - attention, visual scanning, speed of eye-hand coordination, and information processing; and part B - working memory and the ability to switch between different stimuli. Time and number of errors will be registered.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Neuropsychiatric inventory (NPI)
NPI is used to determine the frequency and severity of behavioral and psychological symptoms of dementia (BPSD) with a total score ranging from zero to 144 points with high scores corresponding to worsening of BPSD.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Quality of Life in Alzheimer's Disease scale (QoL-AD)
The QoL-AD will be used to measure the dementia participants' quality of life. The questionnaire includes 13 items such as physical health, energy, mood, memory, family, marriage, friends, and ability to do things for fun. The QoL-AD provides the participant and the caregiver reports of the participant's QoL and is scored on a 4-point Likert-type scale ranging from 1 to 4 (excellent), with total scores ranging between 13 and 52 point, and higher scores indicating better quality of life.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Caregiver subjective burden (CarerQol-7D)
The Care-related Quality of Life instrument (CarerQol) will be used to address subjective burden (CarerQol-7D). The subjective burden is measured in seven dimensions: fulfillment, relational problems, mental health, daily activities problems, physical health and support. Total CarerQol-7D score ranges from 0 to 14 points with higher scores indicating better caregiving situation.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Caregiver subjective well-being (CarerQol-VAS)
The Care-related Quality of Life instrument (CarerQol) will be used to address caregivers' well-being (CarerQol-VAS), using a visual analogue scale to ask about happiness between 0 (completely unhappy) and 10 (completely happy).
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Blood triglycerides (TG), total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)
Determination of TG (mg/dL), TC (mg/dL),LDL-C (mg/dL), HDL-C (mg/dL) concentrations in plasma.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Glycated Hemoglobin (HbA1c)
Determination of HbA1c(μg/mL) concentrations in blood.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Interleukin-6 (IL-6),Interleukin-8 (IL-8), Interleukin-10 (IL-10)
Plasma IL-6 (pg/ml), IL-8 (pg/ml), IL-10 (pg/ml) concentrations will be measured using V-PLEX Human Biomarker 40-Plex Kit pro-inflammatory.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of C-Reactive Protein (CRP) and Tumor Necrosis Factor (TNF-alfa)
Plasma CRP (μg/mL) and TNF-alfa (μg/mL) concentrations will be measured using V-PLEX Human Biomarker 40-Plex Kit pro-inflammatory.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
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)
BDNF (pg/ml), VEGF (pg/ml), sICAM-1 (pg/ml), sVCAM-1 (pg/ml), MMP-9 (pg/ml) concentrations will be analysed using the ELISA method (enzyme-linked immunosorbent assay).
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Insulin-like growth factor-1 (IGF-1)
Plasma IGF-1 (ng/ml) concentrations will be measured by the DiaSorin using a LIAISON ® kit and analysed by CLIA method.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Systolic and Diastolic Blood Pressure
Systolic and Diastolic Blood Pressure (mmHg) will be measured using a digital sphygmomanometer.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Arterial stiffness
Arterial stiffness is going to be measured as carotid-femoral pulse wave velocity (cfPWV) using applanation tonometry (SphygmoCor, AtCor Medical, Australia). Procedures will follow international guidelines. In brief, sequential and consecutive carotid and femoral pressure waves are going to be registered together with the electrocardiogram, which will serve as a reference to calculate the transit time between the recording's sites. The distance traveled by the pressure wave will be the direct distance between the recording points at the femoral and carotid arteries, corrected by the factor 0.8. The value of cfPWV is going to be calculated as the direct distance (in meters) divided by the transit time (in seconds). All measurements will be performed in duplicate by the same trained researcher.
Measured: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2019
- Study start1 Sep 2018
- Primary completionAug 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Sponsor
- Investigators
- Joana Carvalho, PhD, Principal investigator, Universidade do Porto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04095962
- Sponsor's protocol ID
- BB01
- Acronym
- Body&Brain
- Status last verified
- Sep 2020
- First submitted
- 20 Aug 2019
- Last updated
- 17 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Marques-Aleixo I, Sampaio A, Bohn L, Machado F, Barros D, Ribeiro O, Carvalho J, Magalhaes J. Neuropsychiatric Symptoms are Related to Blood-biomarkers in Major Neurocognitive Disorders. Curr Aging Sci. 2024;17(1):74-84. doi: 10.2174/1874609816666230816090934.
PubMed 37904566Borges-Machado F, Teixeira L, Carvalho J, Ribeiro O. Does Multicomponent Physical Exercise Training Work for Dementia? Exploring the Effects on Cognition, Neuropsychiatric Symptoms, and Quality of Life. J Geriatr Psychiatry Neurol. 2023 Sep;36(5):376-385. doi: 10.1177/08919887221149152. Epub 2022 Dec 27.
PubMed 36574616Borges-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.
PubMed 34732148Borges-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.
PubMed 33778911Carvalho 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.
PubMed 33663414Sampaio 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.
PubMed 33407194
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body and Brain: Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia
- ClinicalTrials.gov ID
- NCT04095962
- Acronym / sponsor ID
- Body&Brain / BB01
- Keywords
- Functionality, Multimodal, Cognition
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 19 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: ExerciseTraining protocol will be held for 6 months, twice per week/ 60 min per sessions. |
| Control Group | No intervention | –Participants in the control group will receive monthly sessions regarding physical activity and health related topics as a complement to standard care. No specific exercise intervention will be conducted for this group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Multicomponent trainingThe MT program will be conducted for 6 months, twice a week in 60 minutes sessions. Sessions will be divided in warm-up (10 minutes, including slow walk, postural and mobility exercises for general activation, and stretching exercises), specific training (35-45 minutes, including balance/coordination training, strength and aerobic exercises) and cool down (5 minutes with breathing and stretching exercises for the main worked joints and muscles) following the main guidelines recommended by the American College of Sports Medicine [18] and the WHO [19]. | Other | Experimental Group |
Primary outcome
Change from Baseline on Short Physical Performance Battery (SPBB)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
The Short Physical Performance Battery (SPPB) is a standardised assessment tool of lower limb function, testing 3 dimensions: standing balance, walking speed, and chair stands. Each component is scored between 0-4, total score from 0 (poor performance) to 12 (best performance).
Change from Baseline on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
To evaluate cognitive function with a total scoring ranging between 0 - 68. A score of 68 represents the most severe impairment and 0 represents the least impairment.
27 secondary outcomes
Change from Baseline on 30-second Chair-stand Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 30-second Arm Curl Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 2-minute Step Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on 8-Foot Up and Go Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Back Scratch Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Sit and reach Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Modified Bruce Treadmill Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on One Leg Balance Test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Handgrip test
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Appendicular Skeletal Muscle Mass Index (ASMI)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Body mass, fat-free mass, fat mass
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Barthel Index (BI)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Lawton & Brody (IADL)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Mini-Mental State Examination (MMSE)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Trail-making test (TMT)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Neuropsychiatric inventory (NPI)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Quality of Life in Alzheimer's Disease scale (QoL-AD)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Caregiver subjective burden (CarerQol-7D)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Caregiver subjective well-being (CarerQol-VAS)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Blood triglycerides (TG), total cholesterol (TC), Low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Glycated Hemoglobin (HbA1c)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Interleukin-6 (IL-6),Interleukin-8 (IL-8), Interleukin-10 (IL-10)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of C-Reactive Protein (CRP) and Tumor Necrosis Factor (TNF-alfa)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
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)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Circulating levels of Insulin-like growth factor-1 (IGF-1)
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Systolic and Diastolic Blood Pressure
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Change from Baseline on Arterial stiffness
Time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2021.
- Derived from this study: PubMed 37904566Marques-Aleixo I, Sampaio A, Bohn L, Machado F, Barros D, Ribeiro O, Carvalho J, Magalhaes J. Neuropsychiatric Symptoms are Related to Blood-biomarkers in Major Neurocognitive Disorders. Curr Aging Sci. 2024;17(1):74-84. doi: 10.2174/1874609816666230816090934.
- Derived from this study: PubMed 36574616Borges-Machado F, Teixeira L, Carvalho J, Ribeiro O. Does Multicomponent Physical Exercise Training Work for Dementia? Exploring the Effects on Cognition, Neuropsychiatric Symptoms, and Quality of Life. J Geriatr Psychiatry Neurol. 2023 Sep;36(5):376-385. doi: 10.1177/08919887221149152. Epub 2022 Dec 27.
- Derived from this study: PubMed 34732148Borges-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.
- Derived from this study: PubMed 33778911Borges-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.
- Derived from this study: PubMed 33663414Carvalho 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.
- Derived from this study: PubMed 33407194Sampaio 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joana Carvalho, PhD principal investigator
Universidade do Porto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Dementia and Alzheimer Disease, run by Universidade do Porto at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joana Carvalho, PhD (+351 220425316, Jcarvalho@fade.up.pt), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline on Short Physical Performance Battery (SPBB) (time frame: Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04095962, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2021.