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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02116114
Other study ID # 13/11
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 14, 2014
Last updated April 14, 2014
Start date May 2014
Est. completion date December 2014

Study information

Verified date April 2011
Source Universidade Metodista de Piracicaba
Contact Marlene A Moreno, PHD
Phone +55 (19) 31241515
Email ma.moreno@terra.com.br
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Interventional

Clinical 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).


Description:

First paragraph

- aquatic aerobic physical training program

- beneficial adaptations

Next paragraph

- cardiovascular

- respiratory

- systemic inflammation

- functional capacity

- quality of life


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 24
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Male
Age group 50 Years to 70 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms

  • Adverse Effects in the Aquatic Exercises

Intervention

Other:
Aerobic training
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 .

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidade Metodista de Piracicaba

Outcome

Type Measure Description Time frame Safety issue
Other Change from baseline in systemic inflammation by C-reactive protein at week 8 Baseline, Week 8 No
Primary Change from baseline in cardiac autonomic modulation by heart rate variability at week 8 Baseline, Week 8 No
Secondary Change from baseline in quality of life by the Saint George Respiratory Questionnaire at week 8 Baseline, Week 8 No