COPDNCT01691131
Effects of Two Training Protocols in Patients With Chronic Obstructive Pulmonary Disease
A study testing Exercise training in people with COPD, run by Universidade Norte do Paraná at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- COPD
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2011to 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- COPD
- Being tested
- Exercise training
- Keywords
- Physical activity in daily life, Balance, COPD, Exercise training
- 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.
Exercise trainingOther
Also called Exercise training on land;, Exercise training on water.
Comparison of high intensity exercise training on land versus water.
| Study group | Role | What they receive |
|---|---|---|
| Exercise training on land | Other | High intensity exercise training on land. Receives: Other: Exercise training |
| Exercise training on water | Other | High intensity exercise training on water. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical activity in daily life (measuremet unit: number of steps per day)
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.
Measured: four years
Secondary outcomes (5)
Static Balance (Center of Pressure Area in cm2)
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.
Measured: four years
Dynamic Balance (Timed up and go test in seconds)
Dynamic balance will be assessed by Timed up and go test (TUG).
Measured: four years
Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)
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.
Measured: four years
Quality of life (CRDQ: score in points)
The Chronic Respiratory Disease Questionnaire (CRDQ) will be applied to assess quality of life.
Measured: four years
Functional status (LCADL: score in points)
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.
Measured: four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2012 (estimated)
- Study startJul 2011
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COPDStudies 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
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Norte do Paraná
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Pitta, PhD, Study director, Universidade Estadual de LondrinaVanessa S. Probst, PhD, Principal investigator, Universidade Norte do Paraná
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691131
- Sponsor's protocol ID
- Unopar
- Status last verified
- Apr 2018
- First submitted
- 12 Apr 2012
- Last updated
- 6 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
de Castro LA, Felcar JM, de Carvalho DR, Vidotto LS, da Silva RA, Pitta F, Probst VS. Effects of land- and water-based exercise programmes on postural balance in individuals with COPD: additional results from a randomised clinical trial. Physiotherapy. 2020 Jun;107:58-65. doi: 10.1016/j.physio.2019.08.001. Epub 2019 Aug 6.
PubMed 32026836Felcar JM, Probst VS, de Carvalho DR, Merli MF, Mesquita R, Vidotto LS, Ribeiro LRG, Pitta F. Effects of exercise training in water and on land in patients with COPD: a randomised clinical trial. Physiotherapy. 2018 Dec;104(4):408-416. doi: 10.1016/j.physio.2017.10.009. Epub 2018 Mar 1.
PubMed 30477678
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Two Training Protocols in Physical Activity in Daily Life and Balance in Patients With COPD: Land Versus Water
- ClinicalTrials.gov ID
- NCT01691131
- Acronym / sponsor ID
- Unopar
- Conditions
- COPD
- Keywords
- Physical activity in daily life, Balance, COPD, Exercise training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Universidade Norte do ParanáUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 24 Sep 2012 (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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise training on land | Other | Other: Exercise trainingHigh intensity exercise training on land. |
| Exercise training on water | Other | Other: Exercise trainingHigh intensity exercise training on water. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
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 |
|---|---|---|
| Exercise trainingAlso: Exercise training on land;, Exercise training on water.Comparison of high intensity exercise training on land versus water. | Other | Exercise training on land, Exercise training on water |
Primary outcome
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.
5 secondary outcomes
Static Balance (Center of Pressure Area in cm2)
Time frame: four years
Dynamic Balance (Timed up and go test in seconds)
Time frame: four years
Exercise capacity (6MWT: distance covered in meters; ISWT: distance covered in meters)
Time frame: four years
Quality of life (CRDQ: score in points)
Time frame: four years
Functional status (LCADL: score in points)
Time frame: four years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2018.
- Derived from this study: PubMed 32026836de Castro LA, Felcar JM, de Carvalho DR, Vidotto LS, da Silva RA, Pitta F, Probst VS. Effects of land- and water-based exercise programmes on postural balance in individuals with COPD: additional results from a randomised clinical trial. Physiotherapy. 2020 Jun;107:58-65. doi: 10.1016/j.physio.2019.08.001. Epub 2019 Aug 6.
- Derived from this study: PubMed 30477678Felcar JM, Probst VS, de Carvalho DR, Merli MF, Mesquita R, Vidotto LS, Ribeiro LRG, Pitta F. Effects of exercise training in water and on land in patients with COPD: a randomised clinical trial. Physiotherapy. 2018 Dec;104(4):408-416. doi: 10.1016/j.physio.2017.10.009. Epub 2018 Mar 1.
- Individual participant dataSharing planned: No
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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.
Fabio Pitta, PhD study director
Universidade Estadual de Londrina
Vanessa S. Probst, PhD principal investigator
Universidade Norte do Paraná
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with COPD, run by Universidade Norte do Paraná at 1 site in Brazil.
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 4 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: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Physical activity in daily life (measuremet unit: number of steps per day) (time frame: four years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01691131, which also lists 2 linked publications.
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 6 Apr 2018.