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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443375
Other study ID # 835.733
Secondary ID
Status Completed
Phase N/A
First received February 8, 2018
Last updated February 16, 2018
Start date January 2015
Est. completion date December 2015

Study information

Verified date February 2018
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The present study aimed at investigating the effects of two different resistance training protocols — nonperiodized (NP) and daily undulating periodization (DUP) — on hemodynamic, morphofunctional and cognitive parameters of robust older women. Methods: Forty-two older women were randomized allocated into one of the three experimental groups: NP, DUP, and control group (CG). Evaluations of the hemodynamic, morphofunctional and cognitive parameters occurred before, during and after six months. The exercise groups performed the program of exercise twice a week over 22 weeks. In NP, the two weekly sessions were based on 3 sets of 8-10 repetitions at a difficult intensity. However, in DUP, a power exercise session based on 3 sets of 8-10 repetitions at a moderate intensity was added in the first session of the week.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date December 2015
Est. primary completion date December 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Aged =60 years;

- Female;

- Not having been part of a systematic program of physical exercises in the last 6 months;

- MEEM score >19 points;

- Kihon checklist score >10 points;

- Capacity to perform the basic and instrumental activities of daily living according to Katz and Pfeffer indexes;

- Self-reported good memory;

- Complete all measurements.

Exclusion Criteria:

- Changes on antihypertensive medication in the past 6 months prior to inclusion in the study;

- Cardiovascular disease (i.e., acute myocardial infarction, stroke, peripheral arterial disease, and transient ischemic disease)

- Metabolic disease (i.e., diabetes mellitus type I or II), pulmonary disease (i.e., emphysema)

- Neurological and/or psychiatric disease (i.e., Parkinson's or Alzheimer's disease)

- Skeletal muscle disorders

- Comorbidities associated with greater risk of falls

- Recent history of smoking or alcohol abuse

- Hormone replacement therapy and/or psychotropic drugs.

Study Design


Intervention

Other:
Physical exercise
The interventions proposed in the present trial were based on a safe and well-established exercise training program

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of Campinas, Brazil

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in transfer capacity in seconds TUG performance 6 months
Secondary Changes in fat-free mass in kg Fat-free mass 6 months
Secondary Changes in overall cognitive capacity in points MEEM 6 months
Secondary Changes in blood pressure in mmHg Blood Pressure 6 months
Secondary Changes in shor-term memory in points Memory 6 months
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