NCT04294485

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 28, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 4, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2020

Completed
Last Updated

March 4, 2020

Status Verified

March 1, 2020

Enrollment Period

4 months

First QC Date

November 12, 2019

Last Update Submit

March 3, 2020

Conditions

Pleural Effusion

Keywords

Physical therapyPleural effusion

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (3)

  • Functional capacity

    Baseline

  • Functional capacity

    Up to 7 days

  • Functional capacity

    Up to 3 months

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Behavioral: Physical therapy

Control group

NO INTERVENTION

Participants will no receive physical therapy intervention

Interventions

Physical therapyBEHAVIORAL

Electrostimulation combined with exercise

Experimental group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Physical Therapy

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Pleural Effusion

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Pleural DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single (participant)
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 12, 2019

First Posted

March 4, 2020

Study Start

February 28, 2020

Primary Completion

June 12, 2020

Study Completion

December 30, 2020

Last Updated

March 4, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)