Physiotherapy in Hypoxic AECOPD Patients
2 maart 2020 bijgewerkt door: Marie Carmen Valenza, Universidad de Granada
Feasibility and Efficacy of Physiotherapy in Hypoxic AECOPD Patients
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.
Studie Overzicht
Toestand
Onbekend
Conditie
Interventie / Behandeling
Studietype
Ingrijpend
Inschrijving (Verwacht)
36
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Granada
-
Granada., Granada, Spanje, 18071
- Werving
- Faculty of Health Sciences. University of Granada.
-
Contact:
- Marie Carmen Valenza, PT
- Telefoonnummer: 958 248035
- E-mail: cvalenza@ugr.es
-
Hoofdonderzoeker:
- Marie Carmen Valenza, PT, PhD
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
40 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Global Exercise Group
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.
|
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
|
|
Experimenteel: Functional Electrostimulation Group
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. |
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. |
|
Actieve vergelijker: Standard 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.
|
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
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Lower limb strength
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Lower limb strength
Tijdsspanne: 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.
|
Up to 9 days
|
|
Balance
Tijdsspanne: Baseline
|
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.
|
Baseline
|
|
Balance
Tijdsspanne: 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.
|
Up to 9 days
|
|
Dyspnea
Tijdsspanne: Baseline
|
Dyspnea was assessed at rest using the modified Borg scale.
Patients classified their breathlessness from 0 (no dyspnea) to10 (maximal dyspnea)
|
Baseline
|
|
Dyspnea
Tijdsspanne: 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)
|
Up to 9 days
|
|
Fatigue
Tijdsspanne: Baseline
|
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
|
Baseline
|
|
Fatigue
Tijdsspanne: 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
|
Up to 9 days
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 december 2019
Primaire voltooiing (Werkelijk)
1 januari 2020
Studie voltooiing (Verwacht)
1 april 2020
Studieregistratiedata
Eerst ingediend
17 februari 2020
Eerst ingediend dat voldeed aan de QC-criteria
2 maart 2020
Eerst geplaatst (Werkelijk)
4 maart 2020
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 maart 2020
Laatste update ingediend die voldeed aan QC-criteria
2 maart 2020
Laatst geverifieerd
1 maart 2020
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- DF0089UG
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .