Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2012 by Universidade Norte do Paraná
Sponsor:
Information provided by (Responsible Party):
Universidade Norte do Paraná
ClinicalTrials.gov Identifier:
NCT01691131
First received: April 12, 2012
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

Introduction: There is evidence that demonstrate the beneficial effects of pulmonary rehabilitation programs (PR) on symptoms, exercise capacity, muscle strength and quality of life in patients with Chronic obstructive pulmonary disease (COPD). The majority of the studies used high intensity endurance and strength exercise training on land. Exercise on water is an effective form of training that has been used for decades for rehabilitation in different chronic conditions. In addition, there are promising preliminary results on the literature regarding aquatic training in patients with COPD. However, several gaps remain.

Aim: Compare the effects of two rehabilitation programs with 6 months of duration in patients with COPD on physical activity in daily life and balance: land versus water.

Methods: The sample will consist of 60 patients with COPD diagnosed according to the GOLD criteria, 50 years old or more and clinically stable.

Patients will be evaluated in 3 different moments: before the PR, after the PR and 6 months after the end of the PR (follow up). In addition to the assessment of physical activity in daily life and balance, the investigators will also evaluate pulmonary function, peripheral and respiratory muscle strength, body composition, maximal and submaximal exercise capacity, functional status and quality of life.

Both groups (land or water) will be submitted for 3 sessions of exercise training per week, with 45 minutes of duration, during 6 months. The sessions of both groups include the same exercises sequence. Endurance exercise training will be performed on a bicycle and walking on land and strength training using free weights. Workload will be established according to the tests performance on assessment and progression will follow a predetermined schedule and adjusted according symptoms. On water the same approach will be followed.

Expected results: the investigators expect improvement in terms of symptoms, exercise capacity, muscle strength, quality of life, functional status and physical activity in daily life at the end of the two training protocols. However, it is unclear whether one training protocol will be superior than the other. Due to the characteristics involved in the aquatic training, the investigators hypothesized that this type of training can result in better results on balance.


Condition Intervention
COPD
Other: Exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water

Resource links provided by NLM:


Further study details as provided by Universidade Norte do Paraná:

Primary Outcome Measures:
  • Physical activity in daily life [ Time Frame: four years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Balance [ Time Frame: four years ] [ Designated as safety issue: Yes ]
  • Exercise capacity [ Time Frame: four years ] [ Designated as safety issue: Yes ]
  • Quality of life [ Time Frame: four years ] [ Designated as safety issue: Yes ]
  • functional status [ Time Frame: four years ] [ Designated as safety issue: Yes ]
    Functional status will be assessed by using the questionnaire "London Chest Activity of Daily Living scale". A total score is calculated according to the patient report for each domain.


Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Exercise training on land
High intensity exercise training on land.
Other: Exercise training
Comparison of high intensity exercise training on land versus water.
Other Names:
  • Exercise training on land;
  • Exercise training on water.
Exercise training on water
High intensity exercise training on water.
Other: Exercise training
Comparison of high intensity exercise training on land versus water.
Other Names:
  • Exercise training on land;
  • Exercise training on water.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD diagnosis (according to the GOLD criteria);
  • Stable condition, no exacerbations or infections in the last 3 months;
  • No severe or unstable heart disease;
  • No other pathological conditions that could influence the training performance;
  • Not have participated in other rehabilitation programs in the last six months.

Exclusion Criteria:

  • Occurrence of acute exacerbation during the evaluation period;
  • Not understanding or non-cooperation regarding the procedures and research methods;
  • Option of the participant to leave the study for any reason;
  • Presence of vestibular disorders (BPPV, labyrinthitis, among others).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691131

Locations
Brazil
Universidade Norte do Paraná Recruiting
Londrina, Paraná, Brazil, 86041-120
Contact: Vanessa S Probst, PhD    +55 (43) 33719848    vanessaprobst@uol.com.br   
Sponsors and Collaborators
Universidade Norte do Paraná
Investigators
Study Director: Fabio Pitta, PhD Universidade Estadual de Londrina
Principal Investigator: Vanessa S. Probst, PhD Universidade Norte do Paraná
  More Information

No publications provided

Responsible Party: Universidade Norte do Paraná
ClinicalTrials.gov Identifier: NCT01691131     History of Changes
Other Study ID Numbers: Unopar
Study First Received: April 12, 2012
Last Updated: September 21, 2012
Health Authority: Brazil: Ethics Committee

Keywords provided by Universidade Norte do Paraná:
Physical activity in daily life
Balance
COPD
Exercise training

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014