Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Not Applicable

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Arm Endurance Exercise Training; Other: Control

• Registration Number: NCT03863717
• Lead Sponsor: European University Cyprus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-14
• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-24
• Last Update Posted: 2020-01-28
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm Endurance Exercise Training Group	Arm Endurance Exercise Training	Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
Control Group	Control	Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training

Primary Outcome Measures

Name	Time	Method
Upper Limb Muscle Strength, hand-grip	Change from Baseline Handgrip Muscle Strength at 3 months	Assess via jamar hand dynamometer
Upper Limb Muscle Strength, triceps	Change from Baseline Triceps Muscle Strength at 3 months	Assess triceps via hand-held dynamometer Micro FET2
Health-related Quality of Life, SGRQ	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
Upper Limb Muscle Strength, biceps brachii	Change from Baseline Biceps Brachii Muscle Strength at 3 months	Assess biceps brachii via hand-held dynamometer Micro FET2
Health-related Quality of Life, CAT	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.
Dyspnea, modified Borg Scale	Change from Baseline Dyspnea at 3 months	Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, mMRC Scale	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	Change from Baseline Fatigue at 3 months	Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Activities of Daily Living with Upper Limbs	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

Trial Locations

Locations (1)

Respiratory Clinic, Nicosia General Hospital; 🇨🇾 Nicosia, Cyprus