Effects of a Multicomponent Exercise Intervention on Physical and Cognitive Function of Older Adults With Dementia

NCT04095962 | Unknown

• 1 other identifier: BB01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer Disease; Vascular Dementia; Neurocognitive Disorders

Keywords

Functionality; Multimodal; Cognition

Outcome Measures

Primary Outcomes (2)

• 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).

  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.

  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

  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

  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

  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

  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

  Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups

Other Outcomes (1)

• Change from Baseline on Daily Physical Activity levels

  Assessment at baseline, immediately after 6 months of intervention, and at 3 months follow-up for experimental and control groups

Study Arms (2)

Experimental Group

EXPERIMENTAL

Training protocol will be held for 6 months, twice per week/ 60 min per sessions.

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.

Interventions

Exercise OTHER

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 \[19\].

Also known as: Multicomponent training

Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade do Porto: lead
• Fundação para a Ciência e a Tecnologia: collaborator

Study Sites (1)

Faculty of Sports of University of Porto

Porto, 4200, Portugal

RECRUITING

Related Publications (6)

• 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.

  PMID: 37904566 DERIVED

• Borges-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.

  PMID: 36574616 DERIVED

• 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.

  PMID: 34732148 DERIVED

• 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.

  PMID: 33778911 DERIVED

• 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.

  PMID: 33663414 DERIVED

• 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.

  PMID: 33407194 DERIVED

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Neurocognitive Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Joana Carvalho, PhD

  Universidade do Porto

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joana Carvalho, PhD

CONTACT

+351 220425316; Jcarvalho@fade.up.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2019
• First Posted: September 19, 2019
• Study Start: September 1, 2018
• Primary Completion: August 1, 2021
• Study Completion: March 1, 2022
• Last Updated: February 17, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)