NCT01983397

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2013

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 14, 2013

Completed
Last Updated

November 14, 2013

Status Verified

November 1, 2013

Enrollment Period

1.1 years

First QC Date

October 31, 2013

Last Update Submit

November 6, 2013

Conditions

Keywords

aged, 80 and overExerciseCognitionBalanceRandomized controlled trial

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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).

    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.

    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

    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

    Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.

Study Arms (3)

Resistance training

EXPERIMENTAL

Resistance training

Other: Resistance training

Multicomponent training

EXPERIMENTAL

Multicomponent training

Other: Multicomponent training

Control Group

NO INTERVENTION

The Control Group did not realize any intervention.

Interventions

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.

Multicomponent 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.

Resistance training

Eligibility Criteria

Age80 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de São Carlos

São Carlos, São Paulo, 13565-905, Brazil

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Juliana H Ansai, specialist

    Universidade Federal de Sao Carlos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

October 31, 2013

First Posted

November 14, 2013

Study Start

August 1, 2012

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

November 14, 2013

Record last verified: 2013-11

Locations