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

April 4, 2018 updated by: Universidade Norte do Paraná

Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

36

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 Locations

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

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
four years
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).
four years
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.
four years
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.
four years
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.
four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Norte do Paraná

Investigators

  • Study Director: Fabio Pitta, PhD, Universidade Estadual de Londrina
  • Principal Investigator: Vanessa S. Probst, PhD, Universidade Norte do Paraná

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2011

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

April 12, 2012

First Submitted That Met QC Criteria

September 21, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Actual)

April 6, 2018

Last Update Submitted That Met QC Criteria

April 4, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Unopar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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