SedentaryNCT01983397
Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Elderly Over 80 Years
A study testing Multicomponent training and Resistance training in people with Sedentary, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
Trial summary
The purpose of this study is to compare the effects of different trainings on cognition and physical performances in elderly over 80 years. Read more about this study
- Who is it for?
- Ages 80 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary
- What is being tested?
- Multicomponent training and Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2012to Sep 2013
- 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 80 to 95 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- age between 80 and 95 years old
- live in community
- sedentary lifestyle
- ability to walk without help from another person with/without aid walking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal de São Carlos
São Carlos, São Paulo, 13565-905
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary
- Being tested
- Multicomponent training, Resistance training
- Keywords
- aged, 80 and over, Exercise, Cognition, Balance, Randomized controlled trial
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multicomponent trainingOther
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.
Resistance trainingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Resistance training | Experimental | Resistance training Receives: Other: Resistance training |
| Multicomponent training | Experimental | Multicomponent training Receives: Other: Multicomponent training |
| Control Group | No intervention | The Control Group did not realize any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline in lower limbs strength after 16 weeks of training and 6 weeks of detraining
Lower limbs strength was assessed by 5 times sit-to-stand test.
Measured: 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
Balance was assessed by unipedal test and tandem test.
Measured: 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
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).
Measured: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining
Changes from baseline in cognition after 16 weeks of training and 6 weeks of detraining
Cognition was evaluated by Montreal Cognitive Assessment.
Measured: Assessed at baseline, after 16 weeks of training and 6 weeks of detraining.
Secondary outcomes (2)
Changes from baseline in number of falls after 16 weeks of training and 6 weeks of detraining
Presence of falls was assessed by falls calendar and phone calls.
Measured: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
Changes from baseline in depression after 16 weeks of training and 6 weeks of detraining
Depression was assessed by abbreviated Geriatric Depression Scale.
Measured: Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2013 (estimated)
- Study startAug 2012
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SedentaryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Sao Carlos
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juliana Hotta Ansai, Universidade Federal de Sao Carlos
- Investigators
- Juliana H Ansai, specialist, Principal investigator, Universidade Federal de Sao Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01983397
- Sponsor's protocol ID
- Ansai-01
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 14 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Oldest Old: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01983397
- Acronym / sponsor ID
- Ansai-01
- Conditions
- Sedentary
- Keywords
- aged, 80 and over, Exercise, Cognition, Balance, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Universidade Federal de Sao CarlosUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 14 Nov 2013 (estimated)
- 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.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Resistance training | Experimental | Other: Resistance trainingResistance training |
| Multicomponent training | Experimental | Other: Multicomponent trainingMulticomponent training |
| Control Group | No intervention | –The Control Group did not realize any intervention. |
Who may qualify
- Ages
- 80 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- age between 80 and 95 years old
- live in community
- sedentary lifestyle
- ability to walk without help from another person with/without aid walking
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Multicomponent trainingThe 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. | Other | Multicomponent training |
| Resistance trainingThe 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. | Other | Resistance training |
Primary outcome
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.
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.
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).
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.
2 secondary outcomes
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2013.
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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.
Juliana H Ansai, specialist principal investigator
Universidade Federal de Sao Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multicomponent training and Resistance training in people with Sedentary, run by Universidade Federal de Sao Carlos at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 14 Nov 2013. 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 Brazil. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2013.