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

NCT ID: NCT06401135

Last Updated: 2024-05-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-28

Study Completion Date

2022-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Diseases Inspiratory Muscle Training Exercise Capacity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Patients will be randomized to the following groups: Group 1 (10% MIP), Group 2 (30% MIP), or Group 3 (60% MIP).
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The patients will be not informed about their groups and they will be evaluated and trained at different places and times

Study Groups

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Control group

Group 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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

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

Low intensity inspiratory muscle training group

Group 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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

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

High intensity inspiratory muscle training group

Group 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.

Group Type EXPERIMENTAL

Inspiratory muscle training

Intervention Type OTHER

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

Interventions

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Inspiratory muscle training

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Uncontrolled hypertension
* Non-stable cardiac disease
* Recent viral infections
* Respiratory, neurological, and orthopedic diseases
* Pregnant and lactating patients
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mustafa Kemal University

OTHER

Sponsor Role lead

Responsible Party

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Nihan Katayıfçı

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nihan Katayıfçı

Role: STUDY_CHAIR

Mustafa Kemal University

Locations

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Hatay Mustafa Kemal University

Hatay, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 27383068 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23560491 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28433237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36325749 (View on PubMed)

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.

Reference Type DERIVED
PMID: 38811888 (View on PubMed)

Other Identifiers

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Hatay Mustafa Kemal U 2

Identifier Type: -

Identifier Source: org_study_id

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