- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03443375
Exercise Periodization and Older Adults
February 16, 2018 updated by: Hélio José Coelho Júnior, University of Campinas, Brazil
Effects of Resistance Training Periodization on Hemodynamic, Morphofunctional and Cognitive Parameters of Robust Older Women.
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
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
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 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: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Nonperiodized resistance training
The Nonperiodized group performed was an intervention based on resistance exercise program with a constant intensity.
|
The interventions proposed in the present trial were based on a safe and well-established exercise training program
|
Experimental: Daily undulating periodized
The Daily undulating periodized program was an intervention based on daily alterations on exercise load. .
|
The interventions proposed in the present trial were based on a safe and well-established exercise training program
|
No Intervention: Control group
The control group remained their regular habits of life during all study period, without engaging in physical exercise programs.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in transfer capacity in seconds
Time Frame: 6 months
|
TUG performance
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in fat-free mass in kg
Time Frame: 6 months
|
Fat-free mass
|
6 months
|
Changes in overall cognitive capacity in points
Time Frame: 6 months
|
MEEM
|
6 months
|
Changes in blood pressure in mmHg
Time Frame: 6 months
|
Blood Pressure
|
6 months
|
Changes in shor-term memory in points
Time Frame: 6 months
|
Memory
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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 (Actual)
January 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
February 8, 2018
First Submitted That Met QC Criteria
February 16, 2018
First Posted (Actual)
February 23, 2018
Study Record Updates
Last Update Posted (Actual)
February 23, 2018
Last Update Submitted That Met QC Criteria
February 16, 2018
Last Verified
February 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 835.733
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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