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Physiotherapy in Hypoxic AECOPD Patients

Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04295655
Enrollment
36
Registered
2020-03-04
Start date
2019-12-01
Completion date
2020-04-01
Last updated
2020-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD Exacerbation

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.

Interventions

OTHERGlobal Exercise intervention

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

OTHERFunctional Electrostimulation Group

The program included a neuromuscular stimulation therapy 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.

OTHERStandard treatment

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

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Lower limb strengthBaselineQuadriceps 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.
BalanceBaselineBalance 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.
DyspneaBaselineDyspnea was assessed at rest using the modified Borg scale. Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
FatigueBaselineFatigue 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

Countries

Spain

Contacts

Primary ContactMarie Carmen valenza, PhD
cvalenza@ugr.es958 248035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026