Renal FailurePhase 4NCT01347775
Inspiratory Muscle Training in Patients With End Stage Renal Failure
A Phase 4 study testing Inspiratory muscle training (URES HS730) in people with Renal Failure and Chronic Renal Insufficiency, run by The University of Queensland at 1 site in Australia.
Trial summary
This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Failure, Chronic Renal Insufficiency
- What is being tested?
- Inspiratory muscle training (URES HS730)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteAustralia
- Study dates
- Dec 2007to Feb 2012
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- documented chronic renal failure
- attending either haemodialysis or pre-dialysis clinic
- age 18
- English speaking
- no prior experience with inspiratory training devices.
Who cannot join
- lung collagen disorders
- renal diseases associated with autoimmune pulmonary diseases
- current pleural effusion
- pulmonary oedema
- decreased conscious level
- behavioural disturbances
- unable or refused to give consent
- taking medications that influence respiratory muscle function (e.g. steroids or cyclophosphamide)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.
Read the detailed description
Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.
This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.
Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.
- Conditions
- Renal Failure, Chronic Renal Insufficiency
- Being tested
- Inspiratory muscle training (URES HS730), Sham inspiratory muscle training (URES HS730)
- Keywords
- Renal failure, Respiratory muscles, Resistance training
- Medical subject headings
- Renal Insufficiency, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle training (URES HS730)Device
Also called Threshold at IMT device URES HS730, Respironics
It will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks
Sham inspiratory muscle training (URES HS730)Device
Also called Threshold at IMT device URES HS730, Respironics
Subjects in the control group underwent sham training, using the same device with the diaphragm removed, thus providing no resistance. They were not given frequency or duration but told to use the device when desired.
| Study group | Role | What they receive |
|---|---|---|
| Sham inspiratory muscle training | Sham comparator | Patients in the sham group used the threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), with the diaphragm removed. Receives: Device: Sham inspiratory muscle training (URES HS730) |
| Inspiratory muscle training | Experimental | Inspiratory muscle training will be by a threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), a commercially available spring-loaded inspiratory muscle training device. It will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks Receives: Device: Inspiratory muscle training (URES HS730) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal inspiratory pressure (MIP)
American Thoracic Society standards
Measured: Change between baseline (enrolment) and 6 weeks
Secondary outcomes (1)
Frenchay activities index
The Frenchay activities index is a measure of instrumental activities of everyday living.The FAI assesses a broad range of activities associated with everyday life including social and family participation
Measured: Change between baseline (enrolment) and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2011 (estimated)
- Study startDec 2007
- Primary completionDec 2011 (estimated)
- Study completionFeb 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal FailureStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Investigators
- Jennifer D Paratz, PhD, Principal investigator, The University of Queensland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01347775
- Sponsor's protocol ID
- IMTRF-06001
- Status last verified
- May 2011
- First submitted
- 29 Apr 2011
- Last updated
- 4 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01347775
- Acronym / sponsor ID
- IMTRF-06001
- Conditions
- Renal Failure, Chronic Renal Insufficiency
- Keywords
- Renal failure, Respiratory muscles, Resistance training
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Feb 2012 (estimated)
- First posted
- 4 May 2011 (estimated)
- 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.
This study will investigate whether inspiratory muscle training in patients with end stage renal failure can improve strength and function.
Detailed description
Patients with chronic renal failure commonly have weak respiratory muscles leading to problems in everyday activities and respiratory infections.
This project aims to investigate if threshold inspiratory muscle training improves the strength, everyday function and participation of patients on haemodialysis. Forty eight patients will be recruited in a randomized controlled trial of inspiratory muscle training vs sham training.
Outcome measures include the maximal inspiratory pressure and the Frenchay activities index. Initial data will be collected by a blinded assessor; the patients will train at 40 % of initial maximal inspiratory pressure for six weeks and be reassessed. If the inspiratory muscle training is effective, it will improve both the physical and functional components of the patient's lives and be recommended for all renal patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham inspiratory muscle training | Sham comparator | Device: Sham inspiratory muscle training (URES HS730)Patients in the sham group used the threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), with the diaphragm removed. |
| Inspiratory muscle training | Experimental | Device: Inspiratory muscle training (URES HS730)Inspiratory muscle training will be by a threshold trainer (Threshold at IMT device URES HS730, Respironics, New Jersey, Inc, Cedar Grove, NJ, USA), a commercially available spring-loaded inspiratory muscle training device. It will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- documented chronic renal failure
- attending either haemodialysis or pre-dialysis clinic
- age 18
- English speaking
- no prior experience with inspiratory training devices.
Key exclusion criteria (8 listed)
- lung collagen disorders
- renal diseases associated with autoimmune pulmonary diseases
- current pleural effusion
- pulmonary oedema
- decreased conscious level
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 |
|---|---|---|
| Inspiratory muscle training (URES HS730)Also: Threshold at IMT device URES HS730, RespironicsIt will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks | Device | Inspiratory muscle training |
| Sham inspiratory muscle training (URES HS730)Also: Threshold at IMT device URES HS730, RespironicsSubjects in the control group underwent sham training, using the same device with the diaphragm removed, thus providing no resistance. They were not given frequency or duration but told to use the device when desired. | Device | Sham inspiratory muscle training |
Primary outcome
Maximal inspiratory pressure (MIP)
Time frame: Change between baseline (enrolment) and 6 weeks
American Thoracic Society standards
1 secondary outcome
Frenchay activities index
Time frame: Change between baseline (enrolment) and 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2011.
Related trials for Renal Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Jennifer D Paratz, PhD principal investigator
The University of Queensland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inspiratory muscle training (URES HS730) in people with Renal Failure and Chronic Renal Insufficiency, run by The University of Queensland at 1 site in Australia.
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 5 inclusion and 8 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 May 2011. 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 Australia. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal inspiratory pressure (MIP) (time frame: Change between baseline (enrolment) and 6 weeks). 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 May 2011.