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Chronic Kidney DiseasesNCT06401135

Effects of Different Inspiratory Muscle Training Protocols in Patients With Chronic Kidney Disease

A study testing Inspiratory muscle training in people with Chronic Kidney Diseases and Inspiratory Muscle Training, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study is to investigate the effects of different IMT protocols on respiratory muscle strength, functional exercise capacity, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), QoL, respiratory function, dyspnoea, fatigue, balance, and PA levels in patients with CKD that were not… Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Inspiratory muscle training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
47 participants
Where
1 siteTurkey (Türkiye)
Study dates
28 Jul 2021to 30 Oct 2022
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with CKD stages 1-5 based on the CKD staging proposed by the Kidney Disease Outcomes Quality Initiative who are not on dialysis
  • Aged>18 years
  • No change in medications over one month

Who cannot join

  • Uncontrolled hypertension
  • Non-stable cardiac disease
  • Recent viral infections
  • Respiratory, neurological, and orthopedic diseases
  • Pregnant and lactating patients

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

  • Hatay Mustafa Kemal University

    Hatay, 31001

Other trials in Turkey (Türkiye)

About this study

Official title: Effects of Different Inspiratory Muscle Training Protocols on Functional Exercise Capacity and Respiratory and Peripheral Muscle Strength in Patients With Chronic Kidney Disease: A Randomized Study

The goal of this study is to investigate the effects of different IMT protocols on respiratory muscle strength, functional exercise capacity, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), QoL, respiratory function, dyspnoea, fatigue, balance, and PA levels in patients with CKD that were not on dialysis.

Read the detailed description

Peripheral and respiratory muscle weakness has been reported in patients with chronic kidney disease (CKD). Management of respiratory muscle weakness is crucial, as reduced functional performance is related to respiratory muscle weakness.

Different IMT function protocols with 30-70% of the maximal inspiratory pressure (MIP) have been found to improve these in patients with CKD. The most efficient IMT intensity for patients with CKD is unknown. Therefore, this study aims to investigate the effects of different IMT protocols on respiratory muscle strength, functional exercise capacity, quadriceps femoris muscle strength (QMS), handgrip muscle strength (HGS), QoL, respiratory function, dyspnoea, fatigue, balance, and PA levels in patients with CKD that were not on dialysis.

Being tested
Inspiratory muscle training
Keywords
Chronic kidney disease, Inspiratory muscle training
Medical subject headings
Renal Insufficiency, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Inspiratory muscle trainingOther

    IMT will be conducted using a pressure threshold-loading device (POWERbreathe® Classic Low Resistance). The groups will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department. physiotherapist

Study groups in NCT06401135
Study groupRoleWhat they receive
Control groupExperimentalGroup 1 will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 10% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 10% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
Receives: Other: Inspiratory muscle training
Low intensity inspiratory muscle training groupExperimentalGroup 2 will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
Receives: Other: Inspiratory muscle training
High intensity inspiratory muscle training groupExperimentalGroup 3 will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 60% of maximal inspiratory pressure (MIP). The MIP will be measured at supervised session each week, and 60% of measured MIP value will be the new training workload. The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department.
Receives: Other: Inspiratory muscle training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Inspiratory muscle strength

    A mouth pressure device will be used to evaluate IMS.

    Measured: First day

Secondary outcomes (13)

  1. Functional exercise capacity

    Functional exercise capacity will be evaluated with 6 minutes working test. Test will be performed in an enclosed 30-m corridor. The patients walk as fast as they could within 6 min.

    Measured: First day

  2. Peripheral muscle strength

    A hand-held dynamometer will be used to measure peripheral muscle strength. The measurements will be repeated three times, and the highest value will be used for comparison.

    Measured: First day

  3. Expiratory muscle strength

    A mouth pressure device will be used to evaluate EMS.

    Measured: First day

  4. Pulmonary functions FEV1

    Spirometry will be used to assess pulmonary function.

    Measured: First day

  5. Pulmonary functions FVC

    Spirometry will be used to assess pulmonary function.

    Measured: First day

  6. Pulmonary functions FEV1/FVC

    Spirometry will be used to assess pulmonary function.

    Measured: First day

  7. Pulmonary functions PEF

    Spirometry will be used to assess pulmonary function.

    Measured: First day

  8. Pulmonary functions FEF25-75%

    Spirometry will be used to assess pulmonary function.

    Measured: First day

  9. Dyspnoea

    Dyspnoea will be measured using the Modified Medical Research Council (MMRC) dyspnoea scale. Levels of dyspnea are graded 0-4.

    Measured: First day

  10. Fatigue

    Fatigue will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 0 to 7.

    Measured: First day

  11. Quality of life assessment

    The Short Form 36 (SF-36) questionnaire will be used to assess QoL and includes both physical and mental components. The scores range from 0 to 100.

    Measured: First day

  12. Physical activity

    Physical activity will be assesed using the International Physical Activity Questionnaire (IPAQ) short form, which includes questions on sitting duration, walking activity, and moderate and vigorous activities.The IPAQ is categorized as inactive (<600 MET-min/week), minimally active (600-3000 MET-min/week), and sufficiently active (>3000 MET-min/week) based on total scores.

    Measured: First day

  13. Balance

    Balance will be evaluated using the Berg Balance Scale (BBS). The scale includes 14 items scoring 0 to 4. Higher scores indicate better balance.

    Measured: First day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 May 2024
  2. Study start28 Jul 2021
  3. Primary completion30 Oct 2022
  4. Study completion30 Oct 2022

Resources

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
Model description
Patients will be randomized to the following groups: Group 1 (10% MIP), Group 2 (30% MIP), or Group 3 (60% MIP).
Masking
Single blind
Who is masked
Participant
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06401135
Sponsor's protocol ID
Hatay Mustafa Kemal U 2
Status last verified
May 2024
First submitted
30 Apr 2024
Last updated
6 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hill NR, Fatoba ST, Oke JL, Hirst JA, O'Callaghan CA, Lasserson DS, Hobbs FD. Global Prevalence of Chronic Kidney Disease - A Systematic Review and Meta-Analysis. PLoS One. 2016 Jul 6;11(7):e0158765. doi: 10.1371/journal.pone.0158765. eCollection 2016.

    PubMed 27383068

  • de Lima MC, Cicotoste Cde L, Cardoso Kda S, Forgiarini LA Jr, Monteiro MB, Dias AS. Effect of exercise performed during hemodialysis: strength versus aerobic. Ren Fail. 2013;35(5):697-704. doi: 10.3109/0886022X.2013.780977. Epub 2013 Apr 8.

    PubMed 23560491

  • de Medeiros AIC, Fuzari HKB, Rattesa C, Brandao DC, de Melo Marinho PE. Inspiratory muscle training improves respiratory muscle strength, functional capacity and quality of life in patients with chronic kidney disease: a systematic review. J Physiother. 2017 Apr;63(2):76-83. doi: 10.1016/j.jphys.2017.02.016. Epub 2017 Mar 14.

    PubMed 28433237

  • Zhang F, Wang H, Bai Y, Huang L, Zhang H. Effect of respiratory muscle training in patients with chronic kidney disease: A systematic review and meta-analysis of randomized controlled trials. Clin Rehabil. 2023 Mar;37(3):348-361. doi: 10.1177/02692155221135729. Epub 2022 Nov 3.

    PubMed 36325749

  • Katayifci N, Huzmeli I, Iri S D, Turgut FH. Effects of different inspiratory muscle training protocols on functional exercise capacity and respiratory and peripheral muscle strength in patients with chronic kidney disease: a randomized study. BMC Nephrol. 2024 May 29;25(1):184. doi: 10.1186/s12882-024-03610-1.

    PubMed 38811888

Questions about this trial

What is this clinical trial studying?

A study testing Inspiratory muscle training in people with Chronic Kidney Diseases and Inspiratory Muscle Training, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 6 May 2024. 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 Turkey (Türkiye). 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Inspiratory muscle strength (time frame: First day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06401135, which also lists 5 linked publications.

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 6 May 2024.

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