- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02116114
Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD
April 14, 2014 updated by: Marlene Aparecida Moreno, Universidade Metodista de Piracicaba
We have as hypothesis that the aquatic aerobic physical training program can help promote beneficial adaptations on the cardiovascular, respiratory and systemic inflammation variables, functional capacity and quality of life in patients with chronic obstructive pulmonary disease (pulmonary emphysema).
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
First paragraph
- aquatic aerobic physical training program
- beneficial adaptations
Next paragraph
- cardiovascular
- respiratory
- systemic inflammation
- functional capacity
- quality of life
Study Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Marlene A Moreno, PHD
- Phone Number: 1503 +55 (19) 31241515
- Email: ma.moreno@terra.com.br
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
50 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Diagnosis of COPD ( GOLD I / II / III / IV rating )
- Clinically stable
- Low level of physical activity , according to the IPAQ ( International Physical Activity Questionnaire )
- Absence of exacerbation in the last three months
- Do not participate in a regular exercise program in the past six months
Exclusion Criteria:
- Diabetes Mellitus
- Endocrine Disorders
- Chronic renal failure
- Liver Diseases
- Other lung diseases or inflammatory diseases associated
- Cardiac
- Use of drugs that prevented physical performance
- Musculoskeletal and neuromuscular changes that make it impossible to run experimental protocols
- Dermatological disorders ( cutaneous fistulas , infected wounds , ringworm skin , varicose ulcers )
- Hypersensitivity to the product used for the treatment of pool water
- Rabies
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: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Aquatic exercises
|
The program of aquatic exercise training was developed involving the following steps : heating : dynamic stretching exercises aerobic exercises , lasting 10 minutes was performed, aquatic fitness : aerobic training and slowdown.
The intensity was prescribed based on the Borg scale score 4-6.
Aerobic training was performed at intervals.
The duration of aerobic fitness was started with eight 20-minute sessions , progressing to eight sessions of 30 minutes and finished with eight 40-minute sessions.
Downturn : global stretching exercises , lasting 10 minutes were performed.
During all sessions , the patients were instructed to breath with pursed - lip .
|
NO_INTERVENTION: control group
The control group participated in the study only to usual care , conventional medical treatment orientation about the disease , methods of energy conservation and evaluation.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in cardiac autonomic modulation by heart rate variability at week 8
Time Frame: Baseline, Week 8
|
Baseline, Week 8
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8
Time Frame: Baseline, Week 8
|
Baseline, Week 8
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in systemic inflammation by C-reactive protein at week 8
Time Frame: Baseline, Week 8
|
Baseline, Week 8
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bruna G Silva, Master, Universidade Metodista de Piracicaba
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
May 1, 2014
Primary Completion (ANTICIPATED)
December 1, 2014
Study Completion (ANTICIPATED)
December 1, 2014
Study Registration Dates
First Submitted
April 14, 2014
First Submitted That Met QC Criteria
April 14, 2014
First Posted (ESTIMATE)
April 16, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
April 16, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
April 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- 13/11
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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