Clinical trial NCT06401135: Effects of Different Inspiratory Muscle Training Protocols in Patients With Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Diseases
Inspiratory Muscle Training
Exercise Capacity
Keywords: Chronic kidney disease
Inspiratory muscle training
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized to the following groups: Group 1 (10% MIP), Group 2 (30% MIP), or Group 3 (60% MIP).
Primary purpose: TREATMENT

Brief 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 on dialysis.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inspiratory muscle strength
timeFrame: First day
Secondary outcomes:
measure: Functional exercise capacity
timeFrame: First day
measure: Peripheral muscle strength
timeFrame: First day
measure: Expiratory muscle strength
timeFrame: First day
measure: Pulmonary functions FEV1
timeFrame: First day
measure: Pulmonary functions FVC
timeFrame: First day
measure: Pulmonary functions FEV1/FVC
timeFrame: First day
measure: Pulmonary functions PEF
timeFrame: First day
measure: Pulmonary functions FEF25-75%
timeFrame: First day
measure: Dyspnoea
timeFrame: First day
measure: Fatigue
timeFrame: First day
measure: Quality of life assessment
timeFrame: First day
measure: Physical activity
timeFrame: First day
measure: Balance
timeFrame: First day
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University
Study officials:
affiliation: Mustafa Kemal University
name: Nihan Katayıfçı
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.