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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01347775




Registration number
NCT01347775
Ethics application status
Date submitted
29/04/2011
Date registered
4/05/2011
Date last updated
4/05/2011

Titles & IDs
Public title
Inspiratory Muscle Training in Patients With End Stage Renal Failure
Scientific title
Inspiratory Muscle Training in Patients With End Stage Renal Failure: a Randomized Controlled Trial
Secondary ID [1] 0 0
IMTRF-06001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Renal Failure 0 0
Chronic Renal Insufficiency 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Inspiratory muscle training (URES HS730)
Treatment: Devices - Sham inspiratory muscle training (URES HS730)

Sham Comparator: Sham inspiratory muscle training - 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.

Experimental: Inspiratory muscle training - 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


Treatment: Devices: Inspiratory muscle training (URES HS730)
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

Treatment: Devices: Sham inspiratory muscle training (URES HS730)
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Maximal inspiratory pressure (MIP)
Timepoint [1] 0 0
Change between baseline (enrolment) and 6 weeks
Secondary outcome [1] 0 0
Frenchay activities index
Timepoint [1] 0 0
Change between baseline (enrolment) and 6 weeks

Eligibility
Key inclusion criteria
- documented chronic renal failure

- attending either haemodialysis or pre-dialysis clinic

- age 18

- English speaking

- no prior experience with inspiratory training devices.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- 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)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Unknown status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2012
Actual
Sample size
Target
48
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane & Womens Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4069 - Brisbane

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will investigate whether inspiratory muscle training in patients with end stage
renal failure can improve strength and function.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01347775
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jennifer D Paratz, PhD
Address 0 0
The University of Queensland
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01347775