NCT01510275

Brief Summary

In a rehabilitation setting, respiratory muscle training with re-expansion techniques in patients following cardio-thoracic surgery represents a consolidated intervention. New devices called RESPILIFT® and RESPIVOl® improve deep inspiration and pulmonary volume with an effect on respiratory muscle performance and perceived dispnoea. The aim of the investigators study is to test the clinical efficacy of RESPILIFT® and RESPIVOl® in patients with a recent history of cardio-thoracic surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

2 active sites

Status
completed

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

Study Start

First participant enrolled

October 1, 2010

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

January 10, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 16, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

October 26, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

January 10, 2012

Last Update Submit

October 25, 2012

Conditions

DyspneaWell Being

Keywords

cardio-thoracic surgerypatientspulmonary volumerespiratory muscle performance

Outcome Measures

Primary Outcomes (1)

  • Respiratory muscle performance

    Change of MEP (Maximum Expiratory Pressure)measure

    Change from Baseline in MEP at 6 months

Secondary Outcomes (5)

  • Respiratory muscle performance

    Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)

  • Pulmonary volumes

    Enrollment (T0), Day 8 (T8), at the end (T14) and after 6 months (T6m)

  • Pulmonary gas exchange

    Enrollment (T0), at the end (T14) and after 6 months (T6m)

  • Perceived dispnoea, well being and thoracic pain

    At enrollment (T0), every day during the treatment (T2,T4, T6, T8, T10, T12), at the end (T14) and after 6 months (T6m)

  • Perceived quality of life

    Enrollment (T0), at the end (T14) and after 6 months (T6m)

Study Arms (2)

Intervention

EXPERIMENTAL

Combined use of RESPIVOL® and RESPILIFT® (with resistive load)

Device: Combined use of RESPIVOL® and RESPILIFT®

Control

SHAM COMPARATOR

Combined use of RESPIVOL® and RESPILIFT® (without resistive load)

Device: Combined use of RESPIVOL® and RESPILIFT®

Interventions

Combined use of RESPIVOL® and RESPILIFT®DEVICE

Active devices (combined) for 14 consecutive session, bid, for 15 minutes.

Intervention

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \> 18 years old
  • recent cardio-thoracic surgery (\< 30 days of admission)
  • compliance to pulmonary rehabilitation program

You may not qualify if:

  • clinical instability
  • concomitant severe co-morbidities
  • inability to use respiratory devices

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Villa Pineta Hospital

Modena, Modena, 41026, Italy

Location

Villa Pineta Hospital

Modena, Modena, Italy

Location

Related Publications (1)

  • Crisafulli E, Venturelli E, Siscaro G, Florini F, Papetti A, Lugli D, Cerulli M, Clini E. Respiratory muscle training in patients recovering recent open cardiothoracic surgery: a randomized-controlled trial. Biomed Res Int. 2013;2013:354276. doi: 10.1155/2013/354276. Epub 2013 Jul 30.

    PMID: 23984352DERIVED

MeSH Terms

Conditions

Dyspnea

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Enrico E Clini, MD

    University of Modena - Ospedale Villa Pineta

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 10, 2012

First Posted

January 16, 2012

Study Start

October 1, 2010

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

October 26, 2012

Record last verified: 2012-10

Locations

IT(2)