Pleural EffusionNCT04294485
Physical Therapy Intervention in Pleural Effusion
A study testing Physical therapy in people with Pleural Effusion, run by Universidad de Granada at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Pleural Effusion
- What is being tested?
- Physical therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- 28 Feb 2020to 30 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria were pleural effusion patients hospitalized.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Physical Therapy
Granada, 18071
Marie Carmen Valenza, PhD, 958242360, cvalenza@ugr.es
Marie Carmen Valenza, PhD
About this study
Official title: 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.
- Conditions
- Pleural Effusion
- Being tested
- Physical therapy
- Keywords
- Physical therapy, Pleural effusion
- Medical subject headings
- Pleural Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical therapyBehavioural
Electrostimulation combined with exercise
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Physical therapy intervention Efficacy of electrostimulation intervention combined with lower limbs exercise. Receives: Behavioral: Physical therapy |
| Control group | No intervention | Participants will no receive physical therapy intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Up to 3 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2020
- Study start28 Feb 2020 (estimated)
- Primary completion12 Jun 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pleural EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marie Carmen Valenza, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04294485
- Sponsor's protocol ID
- DF0085UG
- Status last verified
- Mar 2020
- First submitted
- 12 Nov 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Therapy Intervention in Hospitalized Pleural Effusion Patients
- ClinicalTrials.gov ID
- NCT04294485
- Acronym / sponsor ID
- DF0085UG
- Conditions
- Pleural Effusion
- Keywords
- Physical therapy, Pleural effusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 28 Feb 2020 (estimated)
- Primary completion
- 12 Jun 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 4 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Physical therapyPhysical therapy intervention Efficacy of electrostimulation intervention combined with lower limbs exercise. |
| Control group | No intervention | –Participants will no receive physical therapy intervention |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria were pleural effusion patients hospitalized.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical therapyElectrostimulation combined with exercise | Behavioural | Experimental group |
Primary outcome
EuroQol-5 Dimensions visual analogue scale score
Time frame: Baseline
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
Time frame: Up to 7 days
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
Time frame: Up to 3 months
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
Time frame: Baseline
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
Time frame: Up to 7 days
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
Time frame: Up to 3 months
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).
3 secondary outcomes
Functional capacity
Time frame: Baseline
Functional capacity
Time frame: Up to 7 days
Functional capacity
Time frame: Up to 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical therapy in people with Pleural Effusion, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EuroQol-5 Dimensions visual analogue scale score (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2020.