Physical Therapy Intervention in Pleural Effusion

Pleural Effusion Clinical Trial

Official title:

Physical Therapy Intervention in Hospitalized Pleural Effusion Patients

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04294485
• Other study ID #: DF0085UG
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 28, 2020
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2020
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 30, 2020
• Est. primary completion date: June 12, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pleural Effusion

Intervention

Behavioral:
• Physical therapy
Electrostimulation combined with exercise

Locations

Country	Name	City	State
Spain	Department of Physical Therapy	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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