COPDproTENSNCT03548870
Transcutaneous Electrical Nerve Stimulation During Exercise in Patients With COPD
A study testing CWRT with low frequency transcutaneous electrical nerve stimulation in people with COPD and Physical Activity, run by Groupe Hospitalier du Havre at 1 site in France.
Trial summary
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Read more about this study
- Who is it for?
- Ages 35 to 80 years
- Conditions the study is for
- COPD, Physical Activity, Rehabilitation
- What is being tested?
- CWRT with low frequency transcutaneous electrical nerve stimulation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 23 Oct 2021to 8 Oct 2024
- 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 35 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a diagnosis of COPD
Who cannot join
- exercise contraindication Any musculoskeletal problems, cardiovascular or
- neurological comorbidities that limits exercise.
- pH < 7,35
- Body temperature > 38°C
- cardiac frequency > 100 bpm at rest
- systolic blood pressure < 100 mmHg
Show all 9Show fewer
- exacerbation during the study
- heart pace-maker or defibrillator
- Opiate treatment during the last 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients
- Conditions
- COPD, Physical Activity, Rehabilitation, TEN
- Being tested
- CWRT with low frequency transcutaneous electrical nerve stimulation, CWRT with sham-low frequency transcutaneous electrical nerve stimulation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CWRT with low frequency transcutaneous electrical nerve stimulationOther
4 self adhesive surface electrodes will be positioned by pair on quadriceps. Patients will have a low frequency TENS for 20 min at rest. During this period, intensity will be increased every 5 minutes to the maximum tolerated by the patient (below pain threshold, sensation strong but comfortable). Thereafter, intensity is not increased anymore during the test.
Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional
CWRT with sham-low frequency transcutaneous electrical nerve stimulationOther
4 self adhesive surface electrodes are positioned by pair on quadriceps. Patients will have a sham-low frequency TENS for 20 min at rest. During this period, intensity will be increased for 1 minute to the maximum tolerated by the patient. After this procedure, intensity will be progressively setted back to 1mA. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional
| Study group | Role | What they receive |
|---|---|---|
| Test with TENS | Experimental | Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS Receives: Other: CWRT with low frequency transcutaneous electrical nerve stimulation |
| Test with sham-TENS | Sham comparator | Patients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS Receives: Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison of exercise tolerance
Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions
Measured: two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum
Secondary outcomes (12)
Difference in peripheral muscle oxygenation
Muscle oxygenation (arbitrary unit) will be evaluated using Near-infrared spectroscopy technology.
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Dyspnea
Difference in dyspnea using Modified Borg Scale (0 - 10 points) 0=no dyspnea ; 10 = maximal effort
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Oxygen Saturation
Difference in Oxygen Saturation (%) using a pulse oximetry (SpO2)
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Cardiac Frequency
Difference in Cardiac Frequence (bpm) using a pulse oximetry
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in muscular fatigue
Difference in muscular fatigue using Modified Borg Scale (0 - 10 points) 0=no muscular fatigue ; 10 = maximal effort
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in oxygen consumption
Difference in oxygen consumption (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in carbon dioxide production
Difference in carbon dioxide production (milliliters per minute) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in minute ventilation
Difference in minute ventilation (liters per minute) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in tidal volume
Difference in tidal volume (Liters) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in respiratory rate
Difference in respiratory rate (cycles per minute) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in inspiratory capacity
Difference in inspiratory capacity (Liters) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in respiratory quotient
Difference in respiratory quotient (ratio) will be measured breath-by-breath using a computer-based exercise system
Measured: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2018
- Study start23 Oct 2021
- Primary completion8 Oct 2023
- Study completion8 Oct 2024
Why it stopped: not enough recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier du Havre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03548870
- Sponsor's protocol ID
- 2017-A02290-53
- Acronym
- proTENS
- Status last verified
- Jan 2026
- First submitted
- 17 May 2018
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transcutaneous Electrical Nerve Stimulation During Acute Aerobic Exercise in Patients With Chronic Obstructive Pulmonary Disease After Exacerbation
- ClinicalTrials.gov ID
- NCT03548870
- Acronym / sponsor ID
- proTENS / 2017-A02290-53
- Conditions
- COPD, Physical Activity, Rehabilitation, TEN
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough recruitment
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Groupe Hospitalier du HavreUniversity, hospital or other
- Study start
- 23 Oct 2021 (actual)
- Primary completion
- 8 Oct 2023 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 7 Jun 2018 (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.
Early pulmonary rehabilitation is recommended after an episode of severe exacerbation of chronic obstructive pulmonary disease (COPD). However, its implementation is challenging particularly as regard exercise training. Several studies showed that transcutaneous electrical nerve stimulation (TENS) could improve dyspnea and pulmonary function. The aim of this study is to assess the acute effect of TENS on exercise tolerance in post-exacerbation COPD patients
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test with TENS | Experimental | Other: CWRT with low frequency transcutaneous electrical nerve stimulationPatients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency TENS |
| Test with sham-TENS | Sham comparator | Other: CWRT with sham-low frequency transcutaneous electrical nerve stimulationPatients will perform one Constant Work-Rate Exercise Test at 80% of maximum workload with low frequency sham-TENS |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- a diagnosis of COPD
Key exclusion criteria (9 listed)
- exercise contraindication Any musculoskeletal problems, cardiovascular or
- neurological comorbidities that limits exercise.
- pH < 7,35
- Body temperature > 38°C
- cardiac frequency > 100 bpm at rest
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 |
|---|---|---|
| CWRT with low frequency transcutaneous electrical nerve stimulation4 self adhesive surface electrodes will be positioned by pair on quadriceps. Patients will have a low frequency TENS for 20 min at rest. During this period, intensity will be increased every 5 minutes to the maximum tolerated by the patient (below pain threshold, sensation strong but comfortable). Thereafter, intensity is not increased anymore during the test. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional | Other | Test with TENS |
| CWRT with sham-low frequency transcutaneous electrical nerve stimulation4 self adhesive surface electrodes are positioned by pair on quadriceps. Patients will have a sham-low frequency TENS for 20 min at rest. During this period, intensity will be increased for 1 minute to the maximum tolerated by the patient. After this procedure, intensity will be progressively setted back to 1mA. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional | Other | Test with sham-TENS |
Primary outcome
comparison of exercise tolerance
Time frame: two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum
Comparison of endurance time (Tlim, in second) during constant workload testing (CWRET) under 2 conditions
12 secondary outcomes
Difference in peripheral muscle oxygenation
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Dyspnea
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Oxygen Saturation
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in Cardiac Frequency
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in muscular fatigue
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in oxygen consumption
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in carbon dioxide production
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in minute ventilation
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in tidal volume
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in respiratory rate
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in inspiratory capacity
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Difference in respiratory quotient
Time frame: The outcome will be measure during every CWRET. The two CWRET will be carried out in different days, separate from 24H minimum for a total time frame of 5 days maximum. Data will be continuously collected during exercise
Results and safety
The study was stopped early (reason given: not enough recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CWRT with low frequency transcutaneous electrical nerve stimulation in people with COPD and Physical Activity, run by Groupe Hospitalier du Havre at 1 site in France.
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 9 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: stopped early, as of the sponsor's last update on 21 Jan 2026. 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 France. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: not enough recruitment). Results are not available in the source record.
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?
comparison of exercise tolerance (time frame: two CWRET will be carried out in different days, separate from 24 hours minimum for a total time frame of 5 days maximum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Jan 2026.