ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01691131
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : April 6, 2018
Sponsor:
Information provided by (Responsible Party):
Universidade Norte do Paraná

Brief Summary:

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 36 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 or disease Intervention/treatment Phase
COPD Other: Exercise training Not Applicable

Detailed Description:

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.

Therefore, we aim to 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.

The sample will consist of 36 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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2011
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Physical activity in daily life (measuremet unit: number of steps per day) [ Time Frame: four years ]
    The objectively assessed level of physical activity in daily life will be monitored using the activity monitor Power Walker PW 610 (Yamax, Japan). This device is validated in patients with COPD and the main variables are the number of steps per day and estimation of daily energy expenditure. The monitor will be individually set taking into consideration body weight and step length (measured in a 10-meter walking at usual speed). Patients will wear the device 12 hours per day during 6 days, and the average of these six days will be used for analysis.


Secondary Outcome Measures :
  1. Static Balance (Center of Pressure Area in cm2) [ Time Frame: four years ]
    Static balance will be evaluated using a force platform (BIOMEC400, EMG System of Brazil, Brazil), which is a reliable instrument for stabilographic measures in both, older and young adults.

  2. Dynamic Balance (Timed up and go test in seconds) [ Time Frame: four years ]
    Dynamic balance will be assessed by Timed up and go test (TUG).

  3. Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters) [ Time Frame: four years ]
    The 6-minute walking test (6MWT) will be performed to verify functional exercise capacity and the Incremental shuttle walk test (ISWT) to assess maximal exercise capacity.

  4. Quality of life (CRDQ: score in points) [ Time Frame: four years ]
    The Chronic Respiratory Disease Questionnaire (CRDQ) will be applied to assess quality of life.

  5. Functional status (LCADL: score in points) [ Time Frame: four years ]
    Functional status will be assessed by using the questionnaire "London Chest Activity of Daily Living scale" (LCADL). A total score is calculated according to the patient report for each domain.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691131


Locations
Brazil
Universidade Norte do Paraná
Londrina, Paraná, Brazil, 86041-120
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

Responsible Party: Universidade Norte do Paraná
ClinicalTrials.gov Identifier: NCT01691131     History of Changes
Other Study ID Numbers: Unopar
First Posted: September 24, 2012    Key Record Dates
Last Update Posted: April 6, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

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