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

NCT06401135 | Completed

• 1 other identifier: Hatay Mustafa Kemal U 2
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Inspiratory Muscle Training; Exercise Capacity

Keywords

Chronic kidney disease; Inspiratory muscle training

Outcome Measures

Primary Outcomes (1)

• Inspiratory muscle strength

  A mouth pressure device will be used to evaluate IMS.

  First day

Secondary Outcomes (13)

• Functional exercise capacity

  First day

• Peripheral muscle strength

  First day

• Expiratory muscle strength

  First day

• Pulmonary functions FEV1

  First day

• Pulmonary functions FVC

  First day

Study Arms (3)

Control group

EXPERIMENTAL

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.

Other: Inspiratory muscle training

Low intensity inspiratory muscle training group

EXPERIMENTAL

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.

Other: Inspiratory muscle training

High intensity inspiratory muscle training group

EXPERIMENTAL

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.

Other: Inspiratory muscle training

Interventions

Inspiratory muscle training 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

Control group; High intensity inspiratory muscle training group; Low intensity inspiratory muscle training group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University

Hatay, 31001, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 27383068 BACKGROUND

• 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.

  PMID: 23560491 BACKGROUND

• 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.

  PMID: 28433237 BACKGROUND

• 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.

  PMID: 36325749 BACKGROUND

• 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.

  PMID: 38811888 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Nihan Katayıfçı

  Mustafa Kemal University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will be not informed about their groups and they will be evaluated and trained at different places and times
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

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

Study Record Dates

• First Submitted: April 30, 2024
• First Posted: May 6, 2024
• Study Start: July 28, 2021
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: May 6, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)