Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Universidad de Granada
- Enrollment
- 36
- Locations
- 2
- Primary Endpoint
- Fatigue
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Fatigue
Time Frame: Up to 9 days
Fatigue was evaluated using the Piper Fatigue Scale (PFS) that consists of 22 numerical items which assess multidimensional aspects of fatigue. The scale measures four dimensions of subjective fatigue: "behavioral/severity", relating to the severity, distress, and degree of disruption in activity of daily living; "affective meaning", relating to the emotional meaning attributed to fatigue; "sensory", relating to the physical symptoms of fatigue; and "cognitive/mood", relating to mental and mood states
Lower limb strength
Time Frame: Up to 9 days
Quadriceps strength was assessed with a portable hand-held dynamometer (Lafayette Manual Muscle Testing System, model 01163, Lafayette, IN, USA). The test was performed with the patient seated with his/her knees and hips flexed at 90°. Resistance was applied to the anterior tibia during 5 seconds of maximal muscle contraction. The test was repeated alternatively 3 times on the leg, allowing participants to rest between measurements. The highest value in Newton was selected for the analysis.
Balance
Time Frame: Up to 9 days
Balance was evaluated by the one-leg standing balance test (OLS), that measured the time that the patient balances on one leg as long as possible. The patient choose a leg to stand on (whichever he felt more comfortable with), flex the opposite knee allowing the foot to clear the floor, and balance on one leg. Higher values mean better balance.
Dyspnea
Time Frame: Up to 9 days
Dyspnea was assessed at rest using the modified Borg scale. Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
Secondary Outcomes
No secondary outcomes reported
Investigators
Marie Carmen Valenza
Principal Investigator
Universidad de Granada