Clinical trial NCT03863717: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: European University Cyprus
Sponsor class: OTHER
Collaborators: name: Nicosia General Hospital
First posted: 2019-03-05
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Upper Limb Muscle Strength, biceps brachii
timeFrame: Before Intervention
measure: Upper Limb Muscle Strength, biceps brachii
timeFrame: At 3 months (at the end of intervention)
measure: Upper Limb Muscle Strength, biceps brachii
timeFrame: Change from Baseline Biceps Brachii Muscle Strength at 3 months
measure: Upper Limb Muscle Strength, triceps
timeFrame: Before Intervention
measure: Upper Limb Muscle Strength, triceps
timeFrame: At 3 months (at the end of intervention)
measure: Upper Limb Muscle Strength, triceps
timeFrame: Change from Baseline Triceps Muscle Strength at 3 months
measure: Upper Limb Muscle Strength, hand-grip
timeFrame: Before Intervention
measure: Upper Limb Muscle Strength, hand-grip
timeFrame: At 3 months (at the end of intervention)
measure: Upper Limb Muscle Strength, hand-grip
timeFrame: Change from Baseline Handgrip Muscle Strength at 3 months
measure: Dyspnea, modified Borg Scale
timeFrame: Before Intervention
measure: Dyspnea, modified Borg Scale
timeFrame: At 3 months (at the end of intervention)
measure: Dyspnea, modified Borg Scale
timeFrame: Change from Baseline Dyspnea at 3 months
measure: Dyspnea, mMRC Scale
timeFrame: Before Intervention
measure: Dyspnea, mMRC Scale
timeFrame: At 3 months (at the end of intervention)
measure: Dyspnea, mMRC Scale
timeFrame: Change from Baseline Dyspnea at 3 months
measure: Fatigue
timeFrame: Before Intervention
measure: Fatigue
timeFrame: At 3 months (at the end of intervention)
measure: Fatigue
timeFrame: Change from Baseline Fatigue at 3 months
measure: Health-related Quality of Life, SGRQ
timeFrame: Before Intervention
measure: Health-related Quality of Life, SGRQ
timeFrame: At 3 months (at the end of intervention)
measure: Health-related Quality of Life, SGRQ
timeFrame: Change from Baseline at 3 months
measure: Health-related Quality of Life, CAT
timeFrame: Before Intervention
measure: Health-related Quality of Life, CAT
timeFrame: At 3 months (at the end of intervention)
measure: Health-related Quality of Life, CAT
timeFrame: Change from Baseline at 3 months
measure: Activities of Daily Living with Upper Limbs
timeFrame: Before Intervention
measure: Activities of Daily Living with Upper Limbs
timeFrame: At 3 months (at the end of intervention)
measure: Activities of Daily Living with Upper Limbs
timeFrame: Change from Baseline time at 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Nicosia
country: Cyprus
facility: Respiratory Clinic, Nicosia General Hospital
Study officials:
References:
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.