Physiotherapy in Hypoxic AECOPD Patients

University of Granada (UGR)

Status: Unknown

Conditions: COPD Exacerbation

Treatments: Other: Functional Electrostimulation Group; Other: Standard treatment; Other: Global Exercise intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04295655

DF0089UG

Details and patient eligibility

About

Hypoxia is considered a key player in many of the comorbidities that characterize COPD, such as pulmonary hypertension, skeletal muscle dysfunction, and systemic inflammation. These comorbidities are worsened during an exacerbation due to prolonged bed rest and treatment with steroids, showing a reduction in the quality of life, exercise tolerance, and a greater risk of death in these patients. Therefore, a better understanding of the safety and effectiveness of exercise training for AECOPD patients with resting hypoxemia is needed.

Enrollment: 36 estimated patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of both sexes
• A diagnosis of COPD made according to the criteria of the American Thoracic Society (ATS)
• With hypoxemia at rest defined as mean arterial oxygen saturation below 90%
• Agreed to participate

Exclusion criteria

• Unstable cardiovascular disease
• Orthopedic diseases in the upper and lower limbs
• Being in ICU or use of mechanical ventilation
• Motor sequelae from a neurological or cognitive impairment that interfere with the evaluation and the treatment
• Contraindications of electrotherapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 3 patient groups

Global Exercise Group

Experimental group

Description:

all patients received the Control Group treatment added to global exercise treatment. The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises. The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises. The number of repetitions was adapted to the subject's response taken into account the perceived dyspnea and fatigue during the exercise performance.

Treatment:

Other: Global Exercise intervention

Functional Electrostimulation Group

Experimental group

Description:

all patients received the Control Group treatment plus neuromuscular stimulation therapy (SEFAR Rehab X2, DJO France S.A.S., France) on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017). Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103.

Treatment:

Other: Functional Electrostimulation Group

Standard treatment

Active Comparator group

Description:

Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy.

Treatment:

Other: Standard treatment