Chronic Obstructive Pulmonary DiseaseNCT03863717
Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients
A study testing Arm Endurance Exercise Training in people with Chronic Obstructive Pulmonary Disease, run by European University Cyprus at 1 site in Cyprus.
Trial summary
The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Arm Endurance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCyprus
- Study dates
- 14 Dec 2017to 31 May 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of COPD confirmed by clinical examination and a pulmonary function test
- Stable clinical condition (without recent respiratory system infections or any exacerbation of the disease)
- Patients must be willing to re evaluate at the end of the study
- Patients must be willing to give written consent for their participation in the study
Who cannot join
- Age < 18 years old
- Unstable cardiac disease
- Musculoskeletal and neurological diseases that could affect exercise performance or preclude exercise
- Patients of COPD final stage or other serious disease final stage
- Significant cognitive or psychiatric impairment that would lead to an inability to follow simple commands in a group setting
Trial locations and contacts
1 site in 1 country.
Cyprus1 site, 1 recruiting
- Recruiting
Respiratory Clinic, Nicosia General Hospital
Nicosia
Andreas Georgiou
About this study
The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. The intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. The second group (control group) will participate in the same program but without arm ergometer training.
The study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Arm Endurance Exercise Training, Control
- 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.
Arm Endurance Exercise TrainingOther
Also called Pulmonary Rehabilitation
Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
ControlOther
Also called Pulmonary Rehabilitation
Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training
| Study group | Role | What they receive |
|---|---|---|
| Arm Endurance Exercise Training Group | Experimental | Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer Receives: Other: Arm Endurance Exercise Training |
| Control Group | Active comparator | Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Measured: Before Intervention
Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Measured: At 3 months (at the end of intervention)
Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Measured: Change from Baseline Biceps Brachii Muscle Strength at 3 months
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Measured: Before Intervention
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Measured: At 3 months (at the end of intervention)
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Measured: Change from Baseline Triceps Muscle Strength at 3 months
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Measured: Before Intervention
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Measured: At 3 months (at the end of intervention)
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Measured: Change from Baseline Handgrip Muscle Strength at 3 months
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Measured: Before Intervention
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Measured: At 3 months (at the end of intervention)
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Measured: Change from Baseline Dyspnea at 3 months
Dyspnea, mMRC Scale
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Measured: Before Intervention
Dyspnea, mMRC Scale
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Measured: At 3 months (at the end of intervention)
Dyspnea, mMRC Scale
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Measured: Change from Baseline Dyspnea at 3 months
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Measured: Before Intervention
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Measured: At 3 months (at the end of intervention)
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Measured: Change from Baseline Fatigue at 3 months
Health-related Quality of Life, SGRQ
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Measured: Before Intervention
Health-related Quality of Life, SGRQ
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Measured: At 3 months (at the end of intervention)
Health-related Quality of Life, SGRQ
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Measured: Change from Baseline at 3 months
Health-related Quality of Life, CAT
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Before Intervention
Health-related Quality of Life, CAT
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: At 3 months (at the end of intervention)
Health-related Quality of Life, CAT
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Measured: Change from Baseline at 3 months
Activities of Daily Living with Upper Limbs
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Measured: Before Intervention
Activities of Daily Living with Upper Limbs
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Measured: At 3 months (at the end of intervention)
Activities of Daily Living with Upper Limbs
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Measured: Change from Baseline time at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2019
- Study start14 Dec 2017
- Primary completion31 May 2020 (estimated)
- Study completion31 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European University Cyprus
- Sponsor type
- University, hospital or other
- Collaborators
- Nicosia General Hospital
- Responsible party
- Principal investigator, Christos Karagiannis, European University Cyprus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03863717
- Sponsor's protocol ID
- ΕΕΒΚ/ΕΠ/2017/18
- Status last verified
- Jan 2020
- First submitted
- 14 Feb 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Karagiannis C, Savva C, Korakakis V, Adamide T, Georgiou A, Matheou I, Prodromou A, Xanthos T. Effect of Strength Versus Strength and Endurance Upper Limb Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):426-431. doi: 10.1097/HCR.0000000000000620.
PubMed 34117184
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients
- ClinicalTrials.gov ID
- NCT03863717
- Acronym / sponsor ID
- ΕΕΒΚ/ΕΠ/2017/18
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- European University CyprusUniversity, hospital or other
- Collaborators
- Nicosia General Hospital
- Study start
- 14 Dec 2017 (actual)
- Primary completion
- 31 May 2020 (estimated)
- Study completion
- 31 May 2020 (estimated)
- First posted
- 5 Mar 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.
The aim of the study is to investigate the efficacy of upper limb exercise training in Chronic Obstructive Pulmonary Disease (COPD) patients. For the purpose of the study, a controlled trial will be conducted within Respiratory Clinic of Nicosia General Hospital. The sample will be divided in two groups. The intervention group will participate in a pulmonary rehabilitation program which includes upper and lower extremities exercises, with addition of arm ergometer. The second group (control group) will participate in the same program but without arm ergometer training.
The study's hypothesis is that the intervention group will improve the outcome measures significantly better than the control group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm Endurance Exercise Training Group | Experimental | Other: Arm Endurance Exercise TrainingPulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer |
| Control Group | Active comparator | Other: ControlPulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COPD confirmed by clinical examination and a pulmonary function test
- Stable clinical condition (without recent respiratory system infections or any exacerbation of the disease)
- Patients must be willing to re evaluate at the end of the study
- Patients must be willing to give written consent for their participation in the study
Key exclusion criteria (5 listed)
- Age < 18 years old
- Unstable cardiac disease
- Musculoskeletal and neurological diseases that could affect exercise performance or preclude exercise
- Patients of COPD final stage or other serious disease final stage
- Significant cognitive or psychiatric impairment that would lead to an inability to follow simple commands in a group setting
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 |
|---|---|---|
| Arm Endurance Exercise TrainingAlso: Pulmonary RehabilitationPulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer | Other | Arm Endurance Exercise Training Group |
| ControlAlso: Pulmonary RehabilitationPulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training | Other | Control Group |
Primary outcome
Upper Limb Muscle Strength, biceps brachii
Time frame: Before Intervention
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, biceps brachii
Time frame: At 3 months (at the end of intervention)
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, biceps brachii
Time frame: Change from Baseline Biceps Brachii Muscle Strength at 3 months
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Time frame: Before Intervention
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Time frame: At 3 months (at the end of intervention)
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Time frame: Change from Baseline Triceps Muscle Strength at 3 months
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, hand-grip
Time frame: Before Intervention
Assess via jamar hand dynamometer
Upper Limb Muscle Strength, hand-grip
Time frame: At 3 months (at the end of intervention)
Assess via jamar hand dynamometer
Upper Limb Muscle Strength, hand-grip
Time frame: Change from Baseline Handgrip Muscle Strength at 3 months
Assess via jamar hand dynamometer
Dyspnea, modified Borg Scale
Time frame: Before Intervention
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, modified Borg Scale
Time frame: At 3 months (at the end of intervention)
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, modified Borg Scale
Time frame: Change from Baseline Dyspnea at 3 months
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, mMRC Scale
Time frame: Before Intervention
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Dyspnea, mMRC Scale
Time frame: At 3 months (at the end of intervention)
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Dyspnea, mMRC Scale
Time frame: Change from Baseline Dyspnea at 3 months
Assess via modified Medical Research Council Dyspnea Scale 0 - 4, 0 = breathless only with strenuous exercise, 4 = too breathless to leave the house or breathless when dressing
Fatigue
Time frame: Before Intervention
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Fatigue
Time frame: At 3 months (at the end of intervention)
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Fatigue
Time frame: Change from Baseline Fatigue at 3 months
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Health-related Quality of Life, SGRQ
Time frame: Before Intervention
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Health-related Quality of Life, SGRQ
Time frame: At 3 months (at the end of intervention)
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Health-related Quality of Life, SGRQ
Time frame: Change from Baseline at 3 months
Assess via Saint George Respiratory Questionnaire, A total score incorporates scores from each component of the SGRQ which ranges from 1 to 100, where 0 indicates best health and 100 indicates worst health
Health-related Quality of Life, CAT
Time frame: Before Intervention
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Health-related Quality of Life, CAT
Time frame: At 3 months (at the end of intervention)
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Health-related Quality of Life, CAT
Time frame: Change from Baseline at 3 months
Assess via COPD Assessment Test (CAT), Range of CAT scores from 0-40. Higher scores denote a more severe impact of COPD on a patient's life.
Activities of Daily Living with Upper Limbs
Time frame: Before Intervention
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Activities of Daily Living with Upper Limbs
Time frame: At 3 months (at the end of intervention)
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Activities of Daily Living with Upper Limbs
Time frame: Change from Baseline time at 3 months
Assess via total time need to perform 3 daily activities: (i) simulating of window cleaning, (ii) dry 10 dishes and putting them on a shelf above shoulder level and (iii) putting three packages, each weighing 1000 g, on a shelf above shoulder level
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Derived from this study: PubMed 34117184Karagiannis C, Savva C, Korakakis V, Adamide T, Georgiou A, Matheou I, Prodromou A, Xanthos T. Effect of Strength Versus Strength and Endurance Upper Limb Exercise Training in Patients With Chronic Obstructive Pulmonary Disease: A RANDOMIZED CLINICAL TRIAL. J Cardiopulm Rehabil Prev. 2021 Nov 1;41(6):426-431. doi: 10.1097/HCR.0000000000000620.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arm Endurance Exercise Training in people with Chronic Obstructive Pulmonary Disease, run by European University Cyprus at 1 site in Cyprus.
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 5 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: status not confirmed, as of the sponsor's last update on 28 Jan 2020. 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 Cyprus. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Christos Karagiannis (0035799912547, c.karayiannis@euc.ac.cy), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Upper Limb Muscle Strength, biceps brachii (time frame: Before Intervention). The study lists 27 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 NCT03863717, which also lists 1 linked publication.
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 28 Jan 2020.