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

Sedentary Clinical Trial

Official title:

Effects of Two Physical Exercise Protocols on Cognition and Physical Performances in Oldest Old: a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01983397
• Other study ID #: Ansai-01
• Status: Completed
• Phase: N/A
• First received: October 31, 2013
• Last updated: November 6, 2013
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: November 2013
• Source: Universidade Federal de Sao Carlos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Reserach Ethics Committee of Universidade Federal de São Carlos
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 69
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 80 Years to 95 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Sedentary

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal de São Carlos	São Carlos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Sao Carlos

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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.	Yes
Secondary	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.	Assessed at baseline, during 16 weeks of training and 6 weeks of detraining.	Yes
Secondary	Changes from baseline in depression after 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.	Yes