- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03320005
EFFECTS OF RESISTANCE TRAINING IN ELDERLY
October 19, 2017 updated by: Daysi Tobelem
EFFECTS OF RESISTANCE TRAINING ON THE PHYSICAL AND FUNCTIONAL RESPIRATORY PERFORMANCE OF ELDERLY
This comes from a non-randomized clinical trial, which aims to check on elderly women the effects of a program of resistance training (TR) in physical performance, in respiratory functional capacity, on health and quality of life.
Study Overview
Detailed Description
Will be measured the strength of the respiratory muscles (Mip and Mep), peak expiratory flow (Peak-Flow), thoracic movements and abdominal movements, distance traveled in Incremental Shuttle Walk Test, grip strength manual, pulmonary leukocytes, biochemical parameters and indicators of quality of life and physical activity through the WHOQOL-old and IPAQ-short.
The data will be tested against the distribution of the Gauss curve, by the shapiro-wilk test and, if they have a normal distribution (parametric) are expressed as mean and standard deviation, if not submit normal (non parametric) distribution will be expressed as median or range interquartílico.
The first chance to compare the evolution of the group studied, will be applied to two-way ANOVA.
If the distribution is abnormal, it will apply Mann-Whitney test.
The multiple regression test will be used to compare the Mip and Mep with variables with the Peak-Flow, Thoracoabdominal mobility, distance traveled, immune competence, physical fitness and quality of life in the groups studied.
Study Type
Interventional
Enrollment (Anticipated)
25
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
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 60 year old or more
- Do not have cardiac or respiratory diseases
- neurological, Musculoskeletal and other diseases preventing the practice of exercises
- not being a smoker; agree to participate in the study and signed an informed consent (IC); in the last six months preceding the evaluation did not have participated in physical activity program with the aim of improving physical performance.
Exclusion Criteria:
- Difficult to complete the tasks
- Acute diseases
- Refuse to continue the program
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: ResistanceTraining Group
The RT program has the following features: 05 classes performing two weekly sessions; day shift; sessions with maximum duration of 1 (one) hour; 02 series; 08 to 12 repetitions; interval between sets of 01 to 02 minutes; exercises: bench press, seated leg press 45°, pull forward, Earth, rowing standing calf standing, power lifting, abdominal and development.
|
Resistive exercises for legs and arms
|
|
No Intervention: Non training group
sedentary elderly
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Physical performance
Time Frame: Change from Baseline at 24 weeks
|
distance traveled on ISWT
|
Change from Baseline at 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
quality of life
Time Frame: Change from Baseline at 24 weeks
|
quality of life (WHOQOL-old)
|
Change from Baseline at 24 weeks
|
|
respiratory muscle strength
Time Frame: Change from Baseline at 24 weeks
|
respiratory pressures
|
Change from Baseline at 24 weeks
|
|
Hand grip
Time Frame: Change from Baseline at 24 weeks
|
Hand grip test
|
Change from Baseline at 24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Dirceu Costa, PhD, Nove de Julho University
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, 2017
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
August 7, 2017
First Submitted That Met QC Criteria
October 19, 2017
First Posted (Actual)
October 24, 2017
Study Record Updates
Last Update Posted (Actual)
October 24, 2017
Last Update Submitted That Met QC Criteria
October 19, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- Resist protocol
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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