Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Study Overview
=================
Brief 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.

Official Title
-----------------
Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Other: Arm Endurance Exercise Training
* Other: Control


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm Endurance Exercise Training Group<br>Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer | Other: Arm Endurance Exercise Training<br>* Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer<br>* Other names: Pulmonary Rehabilitation;|
| Active Comparator: Control Group<br>Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training | Other: Control<br>* Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training<br>* Other names: Pulmonary Rehabilitation;|

What is the study measuring?
-----------------
Primary Outcome Measures

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