Physical Therapy Intervention in Pleural Effusion

Physical Therapy Intervention in Hospitalized Pleural Effusion Patients

To know the effects of a physical therapy intervention in patients hospitalized with pleural effusion. The investigators will study the effects of the intervention in hospital stay, health status, psychologica distress and quality of life.

Study Overview

• Status: Unknown
• Conditions: Pleural Effusion
• Intervention / Treatment: Behavioral: Physical therapy

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Department of Physical Therapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Inclusion criteria were pleural effusion patients hospitalized.

Exclusion Criteria:

• Inability to provide informed consent.
• Presence of psychiatric or cognitive disorders.
• Progressive neurological disorders, organ failure, or inability to cooperate.
• Patients who had experienced another pleural effusion in the previous month.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental group; Physical therapy intervention Efficacy of electrostimulation intervention combined with lower limbs exercise.	Behavioral: Physical therapy; Electrostimulation combined with exercise
NO_INTERVENTION: Control group; Participants will no receive physical therapy intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol-5 Dimensions visual analogue scale score	European Quality of Life questionnaire consists of the EQ-5D visual analog scale. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health).	Baseline
EuroQol-5 Dimensions visual analogue scale score	European Quality of Life questionnaire consists of the EQ-5D visual analog scale. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health).	Up to 7 days
EuroQol-5 Dimensions visual analogue scale score	European Quality of Life questionnaire consists of the EQ-5D visual analog scale. The visual analog scale has a rating scale of 0-100 (0 worst possible health, and 100 best possible health).	Up to 3 months
EuroQol-5 Dimensions index score	European Quality of Life questionnaire consists of the EQ-5D index. The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).	Baseline
EuroQol-5 Dimensions index score	European Quality of Life questionnaire consists of the EQ-5D index. The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).	Up to 7 days
EuroQol-5 Dimensions index score	European Quality of Life questionnaire consists of the EQ-5D index. The questionnaire has 5 domains: mobility, self-care, usual activity, pain, and anxiety-depression. For each item, the subject selects one of 3 descriptive health states (from good to poor).	Up to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional capacity	The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.	Baseline
Functional capacity	The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.	Up to 7 days
Functional capacity	The International Physical Activity Questionnaire (IPAQ) short form measures walking, moderate- and vigorous intensity, and total PA and daily time spent sitting on weekdays. PA was reported in MET·minutes/week and days per week and was scored using standardized IPAQ scoring protocols to yield total metabolic equivalent minutes (MET·minutes/week) of PA per week. Sitting time was reported as the amount of time in hours and/or minutes participants spent sitting on a weekday during the past seven days.	Up to 3 months

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): February 28, 2020
• Primary Completion (ANTICIPATED): June 12, 2020
• Study Completion (ANTICIPATED): December 30, 2020

Study Registration Dates

• First Submitted: November 12, 2019
• First Submitted That Met QC Criteria: March 3, 2020
• First Posted (ACTUAL): March 4, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 4, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Physical therapy; Pleural effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Pleural Diseases; Pleural Effusion
• Other Study ID Numbers: DF0085UG

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No