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Physical Therapy Intervention in Pleural Effusion

Primary Purpose

Pleural Effusion

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Physical therapy
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pleural Effusion focused on measuring Physical therapy, Pleural effusion

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Department of Physical Therapy

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental group

Control group

Arm Description

Physical therapy intervention Efficacy of electrostimulation intervention combined with lower limbs exercise.

Participants will no receive physical therapy intervention

Outcomes

Primary Outcome Measures

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).
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).
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).
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).
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).
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).

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
November 12, 2019
Last Updated
March 3, 2020
Sponsor
Universidad de Granada
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1. Study Identification

Unique Protocol Identification Number
NCT04294485
Brief Title
Physical Therapy Intervention in Pleural Effusion
Official Title
Physical Therapy Intervention in Hospitalized Pleural Effusion Patients
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 28, 2020 (Anticipated)
Primary Completion Date
June 12, 2020 (Anticipated)
Study Completion Date
December 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pleural Effusion
Keywords
Physical therapy, Pleural effusion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Single (participant)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Physical therapy intervention Efficacy of electrostimulation intervention combined with lower limbs exercise.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will no receive physical therapy intervention
Intervention Type
Behavioral
Intervention Name(s)
Physical therapy
Intervention Description
Electrostimulation combined with exercise
Primary Outcome Measure Information:
Title
EuroQol-5 Dimensions visual analogue scale score
Description
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).
Time Frame
Baseline
Title
EuroQol-5 Dimensions visual analogue scale score
Description
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).
Time Frame
Up to 7 days
Title
EuroQol-5 Dimensions visual analogue scale score
Description
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).
Time Frame
Up to 3 months
Title
EuroQol-5 Dimensions index score
Description
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).
Time Frame
Baseline
Title
EuroQol-5 Dimensions index score
Description
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).
Time Frame
Up to 7 days
Title
EuroQol-5 Dimensions index score
Description
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).
Time Frame
Up to 3 months
Secondary Outcome Measure Information:
Title
Functional capacity
Description
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.
Time Frame
Baseline
Title
Functional capacity
Description
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.
Time Frame
Up to 7 days
Title
Functional capacity
Description
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.
Time Frame
Up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Department of Physical Therapy
City
Granada
ZIP/Postal Code
18071
Country
Spain
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD
Phone
958242360
Email
cvalenza@ugr.es
First Name & Middle Initial & Last Name & Degree
Marie Carmen Valenza, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Physical Therapy Intervention in Pleural Effusion

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