Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

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 Overview

• Status: Unknown
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: Arm Endurance Exercise Training; Other: Control

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christos Karagiannis; Phone Number: 0035799912547; Email: c.karayiannis@euc.ac.cy

Study Locations

• Cyprus
  • Nicosia, Cyprus
    • Recruiting
    • Respiratory Clinic, Nicosia General Hospital
    • Contact: Andreas Georgiou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm Endurance Exercise Training Group; Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer	Other: Arm Endurance Exercise Training; Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer; Other Names: Pulmonary Rehabilitation
Active Comparator: Control Group; Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training	Other: Control; Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training; 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

Collaborators and Investigators

• Sponsor: European University Cyprus
• Collaborators: Nicosia General Hospital

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2017
• Primary Completion (Anticipated): May 31, 2020
• Study Completion (Anticipated): May 31, 2020

Study Registration Dates

• First Submitted: February 14, 2019
• First Submitted That Met QC Criteria: March 2, 2019
• First Posted (Actual): March 5, 2019

Study Record Updates

• Last Update Posted (Actual): January 28, 2020
• Last Update Submitted That Met QC Criteria: January 24, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: ΕΕΒΚ/ΕΠ/2017/18

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No