Pulmonary Disease, Chronic ObstructiveUEET-COPDNCT00825032
Efficacy of Arm Training in COPD Patients
A study testing comprehensive PR and UEET in people with Pulmonary Disease, Chronic Obstructive, run by Villa Pineta Hospital at 1 site in Italy.
Trial summary
Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD). The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- comprehensive PR and UEET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- Mar 2007to Apr 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- diagnosis of COPD
- a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
- clinical stability for a minimum of 4 weeks
- degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale
Who cannot join
- muscular-skeletal abnormalities limiting the shoulder girdle functionality
- cognitive impairment limiting participation
- previous inclusion in UEET programmes within the last 3 years
- malignancies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).
The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.
Therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.
Read the detailed description
We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.
Patients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.
Patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.
Measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months).
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- comprehensive PR, UEET
- Keywords
- Pulmonary disease, chronic obstructive, Upper extremity, Exercise therapy
- 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.
comprehensive PRProcedure or surgery
Also called Pulmonary Rehabilitation
Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS.
UEETProcedure or surgery
Also called Upper extremity exercise training
Experimental program consisting of 15 additional daily sessions of unsupported UEET.
| Study group | Role | What they receive |
|---|---|---|
| 1: comprehensive PR | Active comparator | Inpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS. Receives: Procedure: comprehensive PR |
| 2: UEET + PR | Experimental | Experimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients. Receives: Procedure: UEET |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-min. ring test (6MRT)
Measured: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
Secondary outcomes (4)
ADL field test
Measured: T0=baseline, Tend (week three)
LCADL
Measured: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
MRC
Measured: T0=baseline, Tend (week three)
6MWT
Measured: T0=baseline, Tend (week three)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startMar 2007
- Primary completionOct 2007
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Villa Pineta Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Investigators
- Stefania Costi, Dr, Principal investigator, University of Modena and Reggio EmiliaEnrico M Clini, Professor, Study chair, Villa Pineta Hospital and University of Modena and Reggio Emilia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825032
- Sponsor's protocol ID
- UEET0307
- Acronym
- UEET-COPD
- Status last verified
- May 2009
- First submitted
- 15 Jan 2009
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Costi S, Di Bari M, Pillastrini P, D'Amico R, Crisafulli E, Arletti C, Fabbri LM, Clini EM. Short-term efficacy of upper-extremity exercise training in patients with chronic airway obstruction: a systematic review. Phys Ther. 2009 May;89(5):443-55. doi: 10.2522/ptj.20070368. Epub 2009 Mar 12.
PubMed 19282362Ries AL, Bauldoff GS, Carlin BW, Casaburi R, Emery CF, Mahler DA, Make B, Rochester CL, Zuwallack R, Herrerias C. Pulmonary Rehabilitation: Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. Chest. 2007 May;131(5 Suppl):4S-42S. doi: 10.1378/chest.06-2418.
PubMed 17494825Costi S, Crisafulli E, Degli Antoni F, Beneventi C, Fabbri LM, Clini EM. Effects of unsupported upper extremity exercise training in patients with COPD: a randomized clinical trial. Chest. 2009 Aug;136(2):387-395. doi: 10.1378/chest.09-0165. Epub 2009 Jun 30.
PubMed 19567487
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Unsupported Upper Extremity Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00825032
- Acronym / sponsor ID
- UEET-COPD / UEET0307
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- Pulmonary disease, chronic obstructive, Upper extremity, Exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Villa Pineta HospitalUniversity, hospital or other
- Collaborators
- University of Modena and Reggio Emilia
- Study start
- Mar 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 19 Jan 2009 (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.
Recent guidelines on pulmonary rehabilitation (PR) recommend upper extremity exercise training (UEET) in patients with chronic obstructive pulmonary disease (COPD).
The theory supporting the inclusion of upper extremity exercise training in the pulmonary rehabilitation for these patients, is based on the profound understanding of the activity of the accessory respiratory muscles, which are competitively involved in both the support of the upper extremities during activities and the ventilation. However, a systematic review of the literature carried out by our staff reveals that the clinical trials carried out up to now to verify the effectiveness of UEET are of poor methodological quality and the investigators cannot corroborate the recommendation recently made on the basis of the results of the investigators' review.
Therefore the investigators began this randomized, parallel groups, controlled clinical trial with the purpose of determining the short-term effect of unsupported UEET on the performance of the upper extremities and on symptoms perceived during activities by patients with COPD.
Detailed description
We recruited inpatients with stable, moderate or severe COPD referred to the PR program at the regional centre of Villa Pineta Hospital.
Patients were randomized into two groups: control and intervention. Patients randomized to the control group undertook an inpatient comprehensive PR that complied with the recommendations made by the ATS/ERS and included a minimum of 15 daily sessions of specific training for lower extremities.
Patients randomized to the intervention group undertook an experimental program consisting of 15 additional daily sessions of unsupported UEET over and above the same PR program used for control patients.
Measurements of upper extremity performance and symptoms perceived were taken in both groups at baseline (T0) and at the completion of the interventions (Tend) by one physiotherapist unaware to the patient's group allocation. To verify if the experimental training leads to long-term results on the functional arm exercise capacity, some measurements were repeated at 6-months as the latest follow-up (T6months).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1: comprehensive PR | Active comparator | Procedure: comprehensive PRInpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS. |
| 2: UEET + PR | Experimental | Procedure: UEETExperimental program consisting in additional 15 daily sessions of unsupported UEET over and above the same PR program used for control patients. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of COPD
- a degree of COPD severity equal or above grade 2 (moderate) on the basis of the GOLD classification
- clinical stability for a minimum of 4 weeks
- degree of chronic dyspnea ≥ grade 2 on the Medical Research Council Dyspnea Scale
Key exclusion criteria (4 listed)
- muscular-skeletal abnormalities limiting the shoulder girdle functionality
- cognitive impairment limiting participation
- previous inclusion in UEET programmes within the last 3 years
- malignancies
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 |
|---|---|---|
| comprehensive PRAlso: Pulmonary RehabilitationInpatient comprehensive PR program that lasted lasted 3 weeks and included a minimum of 15 daily sessions of specific training for lower extremities, education, nutritional intervention, psychosocial intervention. It complied with the recommendation of the ATS/ERS. | Procedure or surgery | 1: comprehensive PR |
| UEETAlso: Upper extremity exercise trainingExperimental program consisting of 15 additional daily sessions of unsupported UEET. | Procedure or surgery | 2: UEET + PR |
Primary outcome
6-min. ring test (6MRT)
Time frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
4 secondary outcomes
ADL field test
Time frame: T0=baseline, Tend (week three)
LCADL
Time frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)
MRC
Time frame: T0=baseline, Tend (week three)
6MWT
Time frame: T0=baseline, Tend (week three)
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 4 Aug 2011.
- Background: PubMed 19282362Costi S, Di Bari M, Pillastrini P, D'Amico R, Crisafulli E, Arletti C, Fabbri LM, Clini EM. Short-term efficacy of upper-extremity exercise training in patients with chronic airway obstruction: a systematic review. Phys Ther. 2009 May;89(5):443-55. doi: 10.2522/ptj.20070368. Epub 2009 Mar 12.
- Background: PubMed 17494825Ries AL, Bauldoff GS, Carlin BW, Casaburi R, Emery CF, Mahler DA, Make B, Rochester CL, Zuwallack R, Herrerias C. Pulmonary Rehabilitation: Joint ACCP/AACVPR Evidence-Based Clinical Practice Guidelines. Chest. 2007 May;131(5 Suppl):4S-42S. doi: 10.1378/chest.06-2418.
- Derived from this study: PubMed 19567487Costi S, Crisafulli E, Degli Antoni F, Beneventi C, Fabbri LM, Clini EM. Effects of unsupported upper extremity exercise training in patients with COPD: a randomized clinical trial. Chest. 2009 Aug;136(2):387-395. doi: 10.1378/chest.09-0165. Epub 2009 Jun 30.
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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.
Stefania Costi, Dr principal investigator
University of Modena and Reggio Emilia
Enrico M Clini, Professor study chair
Villa Pineta Hospital and University of Modena and Reggio Emilia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing comprehensive PR and UEET in people with Pulmonary Disease, Chronic Obstructive, run by Villa Pineta Hospital at 1 site in Italy.
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 4 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 4 Aug 2011. 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 Italy. 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?
6-min. ring test (6MRT) (time frame: T0=baseline, Tend (week three) , T6months (six months after the completion of the training)). 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 NCT00825032, which also lists 3 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 4 Aug 2011.