Adverse Effects in the Aquatic ExercisesNCT02116114
Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD
A study testing Aerobic training in people with Adverse Effects in the Aquatic Exercises, run by Universidade Metodista de Piracicaba.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 70 years, men only
- Conditions the study is for
- Adverse Effects in the Aquatic Exercises
- What is being tested?
- Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Diabetes Mellitus
- Endocrine Disorders
- Chronic renal failure
- Liver Diseases
- Other lung diseases or inflammatory diseases associated
- Cardiac
Show all 11Show fewer
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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).
Read the detailed description
First paragraph
- aquatic aerobic physical training program
- beneficial adaptations
Next paragraph
- cardiovascular
- respiratory
- systemic inflammation
- functional capacity
- quality of life
- Conditions
- Adverse Effects in the Aquatic Exercises
- Being tested
- Aerobic training
- Keywords
- Pulmonary Disease, Chronic Obstructive
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
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 .
| Study group | Role | What they receive |
|---|---|---|
| Aquatic exercises | Experimental | * 3 times a week
* heating
* aerobic training
* slowdown Receives: Other: Aerobic training |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cardiac autonomic modulation by heart rate variability at week 8
Measured: Baseline, Week 8
Secondary outcomes (1)
Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startMay 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Effects in the Aquatic ExercisesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Metodista de Piracicaba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marlene Aparecida Moreno, Universidade Metodista de Piracicaba
- Investigators
- Bruna G Silva, Master, Principal investigator, Universidade Metodista de Piracicaba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02116114
- Sponsor's protocol ID
- 13/11
- Status last verified
- Apr 2011
- First submitted
- 14 Apr 2014
- Last updated
- 16 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Aquatic Physical Training Program on Cardiorespiratory Variables in Patients With COPD
- ClinicalTrials.gov ID
- NCT02116114
- Acronym / sponsor ID
- 13/11
- Conditions
- Adverse Effects in the Aquatic Exercises
- Keywords
- Pulmonary Disease, Chronic Obstructive
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Universidade Metodista de PiracicabaUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
First paragraph
- aquatic aerobic physical training program
- beneficial adaptations
Next paragraph
- cardiovascular
- respiratory
- systemic inflammation
- functional capacity
- quality of life
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aquatic exercises | Experimental | Other: Aerobic training* 3 times a week * heating * aerobic training * slowdown |
| control group | No intervention | –The control group participated in the study only to usual care , conventional medical treatment orientation about the disease , methods of energy conservation and evaluation. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (11 listed)
- Diabetes Mellitus
- Endocrine Disorders
- Chronic renal failure
- Liver Diseases
- Other lung diseases or inflammatory diseases associated
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic trainingThe 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 . | Other | Aquatic exercises |
Primary outcome
Change from baseline in cardiac autonomic modulation by heart rate variability at week 8
Time frame: Baseline, Week 8
1 secondary outcome
Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8
Time frame: Baseline, Week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2014.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruna G Silva, Master principal investigator
Universidade Metodista de Piracicaba
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Adverse Effects in the Aquatic Exercises, run by Universidade Metodista de Piracicaba.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlene A Moreno, PHD (+55 (19) 31241515 ext. 1503, ma.moreno@terra.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cardiac autonomic modulation by heart rate variability at week 8 (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2014.