- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01983397
Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years
November 6, 2013 updated by: Juliana Hotta Ansai, Universidade Federal de Sao Carlos
Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Oldest Old: a Randomized Controlled Trial
The purpose of this study is to compare the effects of different trainings on cognition and physical performances in elderly over 80 years.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo
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São Carlos, São Paulo, Brazil, 13565-905
- Universidade Federal de Sao Carlos
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
80 years to 95 years (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Experimental: Multicomponent training
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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.
|
No Intervention: Control Group
The Control Group did not realize any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in lower limbs strength after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
|
Lower limbs strength was assessed by 5 times sit-to-stand test.
|
Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
|
Changes from baseline in balance after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
|
Balance was assessed by unipedal test and tandem test.
|
Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
|
Changes from baseline in dual task walking after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
|
Dual task was assessed by Timed Up and Go test with a cognitive task (speak day of week in reverse order) and motor task (carry a cup of water).
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Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
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Changes from baseline in cognition after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining.
|
Cognition was evaluated by Montreal Cognitive Assessment.
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Assessed at baseline, after 16 weeks of training and 6 weeks of detraining.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes from baseline in number of falls after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
|
Presence of falls was assessed by falls calendar and phone calls.
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Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
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Changes from baseline in depression after 16 weeks of training and 6 weeks of detraining
Time Frame: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
|
Depression was assessed by abbreviated Geriatric Depression Scale.
|
Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Juliana H Ansai, specialist, Universidade Federal de Sao Carlos
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
September 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
October 31, 2013
First Submitted That Met QC Criteria
November 6, 2013
First Posted (Estimate)
November 14, 2013
Study Record Updates
Last Update Posted (Estimate)
November 14, 2013
Last Update Submitted That Met QC Criteria
November 6, 2013
Last Verified
November 1, 2013
More Information
Terms related to this study
Other Study ID Numbers
- Ansai-01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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