COPDNCT03907839
Effects of Combined Cognitive Rehabilitation in COPD Patients
A study testing clinical trials in people with COPD, run by Faculty of Medicine, Sousse.
Trial summary
This study was to examine the effect of endurance training combined with cognitive training in patients with COPD. The intervention group underwent Cognitive Training added to Endurance Training and the control group underwent only Endurance Training. Read more about this study
- Who is it for?
- Ages 60 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COPD
- What is being tested?
- clinical trials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2016to 15 Mar 2019
- 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 60 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- clinically stable COPD diagnosed by pulmonary function testing (2) absence of heart diseases, severe psychiatric, neurologic or musculoskeletal conditions and /or instable cardiovascular diseases. (3) Absence of medication influencing cognition (4) without history of brain injury, history of stroke or history of alcoholism.
Who cannot join
- smoking COPD
- heart diseases
- instable cardiovascular diseases
About this study
Official title: Effects of Cognitive Training Combined With Pulmonary Rehabilitation on Exercise Tolerance and Cognitive Functions in COPD Patients: a Randomized Controlled Trial
This study was to examine the effect of endurance training combined with cognitive training in patients with COPD. The intervention group underwent Cognitive Training added to Endurance Training and the control group underwent only Endurance Training.
Read the detailed description
Pulmonary rehabilitation is an essential part of the management of COPD. Although various methods and therapies of PR have been used in COPD patients. Furthermore, the Cognitive Training has been performed people with mild cognitive impairments.
Therefore, the combination of endurance training and cognitive tarining could be another alternative to improve the exercise tolerance and cognitive function in patients with COPD. It may also be useful for clinicians interested in designing new rehabilitation therapies. The aim of the study was to analyze the effect of CT combined with ET on exercise tolerance and cognitive functions in COPD patient.
- Conditions
- COPD
- Being tested
- clinical trials
- Keywords
- COPD, cognitive training, cognitive impairment, P300 test, MOCA
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clinical trialsOther
examined two type of training on cognitive parameters for COPD patients
| Study group | Role | What they receive |
|---|---|---|
| Endurance Training (ET) | Active comparator | endurance training for control group Receives: Other: clinical trials |
| ET+cognitive training(CT) | Experimental | endurance training added to cognitive training for exprimental COPD group Receives: Other: clinical trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
6 minute walk test
The patients are instructed to cover the maximal distance in 6 min.Dyspnea was measured using Borg scale before the start of 6MWT and at the end of the test. Portable Spiropalm COSMED recorded heart rate (HR) and oxygen saturation (SpO2) continuously throughout the 6MWT. At the end of the 6MWT, the total covered distance was recorded.
Measured: 1 day
Montreal cognitive assessment test
The test, scored on a scale of 0-30 points, is designed to identify cognitive impairment by assessing multiple cognitive domains.
MOCA scores between 26 and 30 are consid¬ered normal, while scores < 26 indicate cognitive impairment
Measured: 1 day
P300 test
The electroencephalogram signals were recorded with Fz, Cz, and Pz, electrodes. The P3b and P3a components were identified as the largest positive deflections between 250 ms and 500 ms, respectively, in the target and novel responses. Scalp electrode activity was measured at all electrode sites of which Fz, Cz, and Pz were analyzed. Fz, Cz, and Pz were chosen for analyses because ERPs responses are largest on the midline locations.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Dec 2016
- Primary completion15 Dec 2018
- Study completion15 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Medicine, Sousse
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Imen Sanaa, Faculty of Medicine, Sousse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907839
- Sponsor's protocol ID
- pulmonary rehabilitation
- Status last verified
- Apr 2019
- First submitted
- 3 Apr 2019
- Last updated
- 2 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cleutjens FA, Janssen DJ, Ponds RW, Dijkstra JB, Wouters EF. COgnitive-pulmonary disease. Biomed Res Int. 2014;2014:697825. doi: 10.1155/2014/697825. Epub 2014 Mar 16.
PubMed 24738069Dodd JW, Charlton RA, van den Broek MD, Jones PW. Cognitive dysfunction in patients hospitalized with acute exacerbation of COPD. Chest. 2013 Jul;144(1):119-127. doi: 10.1378/chest.12-2099.
PubMed 23349026Bersani FS, Minichino A, Fattapposta F, Bernabei L, Spagnoli F, Mannarelli D, Francesconi M, Pauletti C, Corrado A, Vergnani L, Taddei I, Biondi M, Delle Chiaie R. Prefrontocerebellar transcranial direct current stimulation increases amplitude and decreases latency of P3b component in patients with euthymic bipolar disorder. Neuropsychiatr Dis Treat. 2015 Nov 19;11:2913-7. doi: 10.2147/NDT.S91625. eCollection 2015.
PubMed 26640377Kirkil G, Tug T, Ozel E, Bulut S, Tekatas A, Muz MH. The evaluation of cognitive functions with P300 test for chronic obstructive pulmonary disease patients in attack and stable period. Clin Neurol Neurosurg. 2007 Sep;109(7):553-60. doi: 10.1016/j.clineuro.2007.03.013. Epub 2007 May 29.
PubMed 17532116
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cognitive Training Combined With Pulmonary Rehabilitation on Exercise Tolerance and Cognitive Functions in COPD Patients: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03907839
- Acronym / sponsor ID
- pulmonary rehabilitation
- Conditions
- COPD
- Keywords
- COPD, cognitive training, cognitive impairment, P300 test, MOCA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Faculty of Medicine, SousseUniversity, hospital or other
- Study start
- 15 Dec 2016 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 9 Apr 2019 (actual)
- 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.
This study was to examine the effect of endurance training combined with cognitive training in patients with COPD. The intervention group underwent Cognitive Training added to Endurance Training and the control group underwent only Endurance Training.
Detailed description
Pulmonary rehabilitation is an essential part of the management of COPD. Although various methods and therapies of PR have been used in COPD patients. Furthermore, the Cognitive Training has been performed people with mild cognitive impairments.
Therefore, the combination of endurance training and cognitive tarining could be another alternative to improve the exercise tolerance and cognitive function in patients with COPD. It may also be useful for clinicians interested in designing new rehabilitation therapies. The aim of the study was to analyze the effect of CT combined with ET on exercise tolerance and cognitive functions in COPD patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endurance Training (ET) | Active comparator | Other: clinical trialsendurance training for control group |
| ET+cognitive training(CT) | Experimental | Other: clinical trialsendurance training added to cognitive training for exprimental COPD group |
Who may qualify
- Ages
- 60 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- clinically stable COPD diagnosed by pulmonary function testing (2) absence of heart diseases, severe psychiatric, neurologic or musculoskeletal conditions and /or instable cardiovascular diseases. (3) Absence of medication influencing cognition (4) without history of brain injury, history of stroke or history of alcoholism.
Key exclusion criteria (3 listed)
- smoking COPD
- heart diseases
- instable cardiovascular diseases
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 |
|---|---|---|
| clinical trialsexamined two type of training on cognitive parameters for COPD patients | Other | ET+cognitive training(CT), Endurance Training (ET) |
Primary outcome
6 minute walk test
Time frame: 1 day
The patients are instructed to cover the maximal distance in 6 min.Dyspnea was measured using Borg scale before the start of 6MWT and at the end of the test. Portable Spiropalm COSMED recorded heart rate (HR) and oxygen saturation (SpO2) continuously throughout the 6MWT. At the end of the 6MWT, the total covered distance was recorded.
Montreal cognitive assessment test
Time frame: 1 day
The test, scored on a scale of 0-30 points, is designed to identify cognitive impairment by assessing multiple cognitive domains. MOCA scores between 26 and 30 are consid¬ered normal, while scores < 26 indicate cognitive impairment
P300 test
Time frame: 2 days
The electroencephalogram signals were recorded with Fz, Cz, and Pz, electrodes. The P3b and P3a components were identified as the largest positive deflections between 250 ms and 500 ms, respectively, in the target and novel responses. Scalp electrode activity was measured at all electrode sites of which Fz, Cz, and Pz were analyzed. Fz, Cz, and Pz were chosen for analyses because ERPs responses are largest on the midline locations.
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 2 Aug 2019.
- Background: PubMed 24738069Cleutjens FA, Janssen DJ, Ponds RW, Dijkstra JB, Wouters EF. COgnitive-pulmonary disease. Biomed Res Int. 2014;2014:697825. doi: 10.1155/2014/697825. Epub 2014 Mar 16.
- Background: PubMed 23349026Dodd JW, Charlton RA, van den Broek MD, Jones PW. Cognitive dysfunction in patients hospitalized with acute exacerbation of COPD. Chest. 2013 Jul;144(1):119-127. doi: 10.1378/chest.12-2099.
- Background: PubMed 26640377Bersani FS, Minichino A, Fattapposta F, Bernabei L, Spagnoli F, Mannarelli D, Francesconi M, Pauletti C, Corrado A, Vergnani L, Taddei I, Biondi M, Delle Chiaie R. Prefrontocerebellar transcranial direct current stimulation increases amplitude and decreases latency of P3b component in patients with euthymic bipolar disorder. Neuropsychiatr Dis Treat. 2015 Nov 19;11:2913-7. doi: 10.2147/NDT.S91625. eCollection 2015.
- Background: PubMed 17532116Kirkil G, Tug T, Ozel E, Bulut S, Tekatas A, Muz MH. The evaluation of cognitive functions with P300 test for chronic obstructive pulmonary disease patients in attack and stable period. Clin Neurol Neurosurg. 2007 Sep;109(7):553-60. doi: 10.1016/j.clineuro.2007.03.013. Epub 2007 May 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing clinical trials in people with COPD, run by Faculty of Medicine, Sousse.
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 1 inclusion and 3 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 2 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
6 minute walk test (time frame: 1 day). The study lists 3 primary outcomes in all. 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 NCT03907839, which also lists 4 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 2 Aug 2019.