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Clinical Trials/NCT03863717
NCT03863717
Unknown
N/A

Investigation of the Effectiveness of Upper Limb Exercise in COPD Patients

European University Cyprus1 site in 1 country44 target enrollmentDecember 14, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Chronic Obstructive Pulmonary Disease
Sponsor
European University Cyprus
Enrollment
44
Locations
1
Primary Endpoint
Upper Limb Muscle Strength, triceps
Last Updated
6 years ago

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.

Registry
clinicaltrials.gov
Start Date
December 14, 2017
End Date
May 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Christos Karagiannis

PhD candidate in Physiotherapy

European University Cyprus

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

Outcomes

Primary Outcomes

Upper Limb Muscle Strength, triceps

Time Frame: Change from Baseline Triceps Muscle Strength at 3 months

Assess triceps via hand-held dynamometer Micro FET2

Upper Limb Muscle Strength, hand-grip

Time Frame: Change from Baseline Handgrip Muscle Strength at 3 months

Assess via jamar hand dynamometer

Health-related Quality of Life, SGRQ

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Change from Baseline Dyspnea at 3 months

Assess via modified Borg Scale 0 - 10, 0 = no dyspnea, 10 = maximal dyspnea

Dyspnea, mMRC Scale

Time Frame: 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

Time Frame: 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

Time Frame: 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

Study Sites (1)

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