Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03863717
• Other study ID #: ????/??/2017/18
• Status: Recruiting
• Phase: N/A
• Start date: December 14, 2017
• Est. completion date: May 31, 2020

Study information

• Verified date: January 2020
• Source: European University Cyprus
• Contact: Christos Karagiannis
• Phone: 0035799912547
• Email: c.karayiannis[@]euc.ac.cy
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• Arm Endurance Exercise Training
Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
• Control
Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training

Locations

Country	Name	City	State
Cyprus	Respiratory Clinic, Nicosia General Hospital	Nicosia

Sponsors (2)

Lead Sponsor	Collaborator
European University Cyprus	Nicosia General Hospital

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Upper Limb Muscle Strength, biceps brachii	Assess biceps brachii via hand-held dynamometer Micro FET2	Before Intervention
Primary	Upper Limb Muscle Strength, biceps brachii	Assess biceps brachii via hand-held dynamometer Micro FET2	At 3 months (at the end of intervention)
Primary	Upper Limb Muscle Strength, biceps brachii	Assess biceps brachii via hand-held dynamometer Micro FET2	Change from Baseline Biceps Brachii Muscle Strength at 3 months
Primary	Upper Limb Muscle Strength, triceps	Assess triceps via hand-held dynamometer Micro FET2	Before Intervention
Primary	Upper Limb Muscle Strength, triceps	Assess triceps via hand-held dynamometer Micro FET2	At 3 months (at the end of intervention)
Primary	Upper Limb Muscle Strength, triceps	Assess triceps via hand-held dynamometer Micro FET2	Change from Baseline Triceps Muscle Strength at 3 months
Primary	Upper Limb Muscle Strength, hand-grip	Assess via jamar hand dynamometer	Before Intervention
Primary	Upper Limb Muscle Strength, hand-grip	Assess via jamar hand dynamometer	At 3 months (at the end of intervention)
Primary	Upper Limb Muscle Strength, hand-grip	Assess via jamar hand dynamometer	Change from Baseline Handgrip Muscle Strength at 3 months
Primary	Dyspnea, modified Borg Scale	Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea	Before Intervention
Primary	Dyspnea, modified Borg Scale	Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea	At 3 months (at the end of intervention)
Primary	Dyspnea, modified Borg Scale	Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea	Change from Baseline Dyspnea at 3 months
Primary	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	Before Intervention
Primary	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	At 3 months (at the end of intervention)
Primary	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	Change from Baseline Dyspnea at 3 months
Primary	Fatigue	Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue	Before Intervention
Primary	Fatigue	Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue	At 3 months (at the end of intervention)
Primary	Fatigue	Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue	Change from Baseline Fatigue at 3 months
Primary	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	Before Intervention
Primary	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	At 3 months (at the end of intervention)
Primary	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	Change from Baseline at 3 months
Primary	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.	Before Intervention
Primary	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.	At 3 months (at the end of intervention)
Primary	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.	Change from Baseline at 3 months
Primary	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	Before Intervention
Primary	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	At 3 months (at the end of intervention)
Primary	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	Change from Baseline time at 3 months