Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

NCT03863717 | Unknown

• 1 other identifier: ΕΕΒΚ/ΕΠ/2017/18
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (27)

• 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

Study Arms (2)

Arm Endurance Exercise Training Group

EXPERIMENTAL

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

Other: Arm Endurance Exercise Training

Control Group

ACTIVE COMPARATOR

Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training

Other: Control

Interventions

Arm Endurance Exercise Training OTHER

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

Also known as: Pulmonary Rehabilitation

Arm Endurance Exercise Training Group

Control OTHER

Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training

Also known as: Pulmonary Rehabilitation

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European University Cyprus: lead
• Nicosia General Hospital: collaborator

Study Sites (1)

Respiratory Clinic, Nicosia General Hospital

Nicosia, Cyprus

RECRUITING

Related Publications (1)

• 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.

  PMID: 34117184 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Christos Karagiannis

CONTACT

0035799912547; c.karayiannis@euc.ac.cy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD candidate in Physiotherapy

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 5, 2019
• Study Start: December 14, 2017
• Primary Completion: May 31, 2020
• Study Completion: May 31, 2020
• Last Updated: January 28, 2020

Record last verified: 2020-01

Locations

CY (1)