MedDataX Logo

Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years

NCT ID: NCT01983397

Last Updated: 2013-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

69 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2013-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to compare the effects of different trainings on cognition and physical performances in elderly over 80 years.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Purpose: To compare the effects of 16-week multicomponent and resistance trainings on cognition and physical performances related to falls in oldest old people living in community; to analyze the same variables after 6-week detraining. Method: We conducted a randomized controlled trial with 69 community elderly over 80 years, sedentary and without cognitive disorder. Participants were allocated to control, multicomponent training or resistance training group. The multicomponent group performed a protocol involving warm-up, aerobic, strength, balance and cool-down exercises. The resistance group underwent to strength exercises using six machines: leg press, chest press, calf, back extension, abdominal and rowing. The control group did not perform any intervention. The trainings had progressive intensity, lasted 16 weeks and included three 1-hour sessions per week. The participants were evaluated at baseline, at the end of 16-week training and at 6-week detraining. The assessment consisted of anamnesis, depression (Geriatric Depression Scale), cognition (Montreal cognitive assessment), dual task walking (associated to cognitive and motor tasks), balance (unipedal and tandem tests), strength of lower limbs (sit-to-stand test) and history of falls. For statistical analysis by intention to treat, we adopted a significance level of α=0.05.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sedentary

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

aged, 80 and over Exercise Cognition Balance Randomized controlled trial

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Resistance training

Resistance training

Group Type EXPERIMENTAL

Resistance training

Intervention Type OTHER

The resistance training was subjected to a strength training using weight machines adapted for elderly. The protocol followed three sets of 10 to 12 maximal repetitions, moderate speed (two seconds for the shortening phase and three seconds for the elongation phase) and one minute for rest interval between sets.

Multicomponent training

Multicomponent training

Group Type EXPERIMENTAL

Multicomponent training

Intervention Type OTHER

The multicomponent training consisted of individuals subjected to a multicomponent exercise program: 5 minute warm up, 20 minutes of aerobic exercise, 15-20 minutes of strength exercises, 10 minutes of coordination, agility and balance exercises and 5 minute of cool-down.

Control Group

The Control Group did not realize any intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multicomponent training

The multicomponent training consisted of individuals subjected to a multicomponent exercise program: 5 minute warm up, 20 minutes of aerobic exercise, 15-20 minutes of strength exercises, 10 minutes of coordination, agility and balance exercises and 5 minute of cool-down.

Intervention Type OTHER

Resistance training

The resistance training was subjected to a strength training using weight machines adapted for elderly. The protocol followed three sets of 10 to 12 maximal repetitions, moderate speed (two seconds for the shortening phase and three seconds for the elongation phase) and one minute for rest interval between sets.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* age between 80 and 95 years old
* live in community
* sedentary lifestyle
* ability to walk without help from another person with/without aid walking

Exclusion Criteria

* any cardiovascular or infectious comorbidity described in the absolute contraindications of the Physical Activity Readiness Medical Examination
* Relative contraindications of cognitive, neurological and/or musculoskeletal comorbidities which make participation in protocols impossible
* Score in mini-state examination mental below the cutoff score designated by education level.
Minimum Eligible Age

80 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidade Federal de Sao Carlos

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Juliana Hotta Ansai

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Juliana H Ansai, specialist

Role: PRINCIPAL_INVESTIGATOR

Universidade Federal de Sao Carlos

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universidade Federal de São Carlos

São Carlos, São Paulo, Brazil

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Brazil

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Ansai-01

Identifier Type: -

Identifier Source: org_study_id