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Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Cyprus
Study Type
Interventional
Intervention
Arm Endurance Exercise Training
Control
Sponsored by
European University Cyprus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Respiratory Clinic, Nicosia General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Endurance Exercise Training Group

Control Group

Arm Description

Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer

Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training

Outcomes

Primary Outcome Measures

Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, biceps brachii
Assess biceps brachii via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, triceps
Assess triceps via hand-held dynamometer Micro FET2
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Upper Limb Muscle Strength, hand-grip
Assess via jamar hand dynamometer
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Dyspnea, modified Borg Scale
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
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
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
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
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Fatigue
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
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
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
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
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.
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.
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.
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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2019
Last Updated
January 24, 2020
Sponsor
European University Cyprus
Collaborators
Nicosia General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03863717
Brief Title
Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients
Official Title
Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
December 14, 2017 (Actual)
Primary Completion Date
May 31, 2020 (Anticipated)
Study Completion Date
May 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
European University Cyprus
Collaborators
Nicosia General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm Endurance Exercise Training Group
Arm Type
Experimental
Arm Description
Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training
Intervention Type
Other
Intervention Name(s)
Arm Endurance Exercise Training
Other Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
Intervention Type
Other
Intervention Name(s)
Control
Other Intervention Name(s)
Pulmonary Rehabilitation
Intervention Description
Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training
Primary Outcome Measure Information:
Title
Upper Limb Muscle Strength, biceps brachii
Description
Assess biceps brachii via hand-held dynamometer Micro FET2
Time Frame
Before Intervention
Title
Upper Limb Muscle Strength, biceps brachii
Description
Assess biceps brachii via hand-held dynamometer Micro FET2
Time Frame
At 3 months (at the end of intervention)
Title
Upper Limb Muscle Strength, biceps brachii
Description
Assess biceps brachii via hand-held dynamometer Micro FET2
Time Frame
Change from Baseline Biceps Brachii Muscle Strength at 3 months
Title
Upper Limb Muscle Strength, triceps
Description
Assess triceps via hand-held dynamometer Micro FET2
Time Frame
Before Intervention
Title
Upper Limb Muscle Strength, triceps
Description
Assess triceps via hand-held dynamometer Micro FET2
Time Frame
At 3 months (at the end of intervention)
Title
Upper Limb Muscle Strength, triceps
Description
Assess triceps via hand-held dynamometer Micro FET2
Time Frame
Change from Baseline Triceps Muscle Strength at 3 months
Title
Upper Limb Muscle Strength, hand-grip
Description
Assess via jamar hand dynamometer
Time Frame
Before Intervention
Title
Upper Limb Muscle Strength, hand-grip
Description
Assess via jamar hand dynamometer
Time Frame
At 3 months (at the end of intervention)
Title
Upper Limb Muscle Strength, hand-grip
Description
Assess via jamar hand dynamometer
Time Frame
Change from Baseline Handgrip Muscle Strength at 3 months
Title
Dyspnea, modified Borg Scale
Description
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Time Frame
Before Intervention
Title
Dyspnea, modified Borg Scale
Description
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Time Frame
At 3 months (at the end of intervention)
Title
Dyspnea, modified Borg Scale
Description
Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea
Time Frame
Change from Baseline Dyspnea at 3 months
Title
Dyspnea, mMRC Scale
Description
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
Time Frame
Before Intervention
Title
Dyspnea, mMRC Scale
Description
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
Time Frame
At 3 months (at the end of intervention)
Title
Dyspnea, mMRC Scale
Description
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
Time Frame
Change from Baseline Dyspnea at 3 months
Title
Fatigue
Description
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Time Frame
Before Intervention
Title
Fatigue
Description
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Time Frame
At 3 months (at the end of intervention)
Title
Fatigue
Description
Assess via modified Borg Scale (0 - 10), 0 = no fatigue, 10 = maximal fatigue
Time Frame
Change from Baseline Fatigue at 3 months
Title
Health-related Quality of Life, SGRQ
Description
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
Time Frame
Before Intervention
Title
Health-related Quality of Life, SGRQ
Description
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
Time Frame
At 3 months (at the end of intervention)
Title
Health-related Quality of Life, SGRQ
Description
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
Time Frame
Change from Baseline at 3 months
Title
Health-related Quality of Life, CAT
Description
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.
Time Frame
Before Intervention
Title
Health-related Quality of Life, CAT
Description
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.
Time Frame
At 3 months (at the end of intervention)
Title
Health-related Quality of Life, CAT
Description
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.
Time Frame
Change from Baseline at 3 months
Title
Activities of Daily Living with Upper Limbs
Description
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
Time Frame
Before Intervention
Title
Activities of Daily Living with Upper Limbs
Description
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
Time Frame
At 3 months (at the end of intervention)
Title
Activities of Daily Living with Upper Limbs
Description
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
Time Frame
Change from Baseline time at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christos Karagiannis
Phone
0035799912547
Email
c.karayiannis@euc.ac.cy
Facility Information:
Facility Name
Respiratory Clinic, Nicosia General Hospital
City
Nicosia
Country
Cyprus
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andreas Georgiou

12. IPD Sharing Statement

Citations:
PubMed Identifier
34117184
Citation
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.
Results Reference
derived

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Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

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