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

Chronic Kidney Diseases Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06401135
• Other study ID #: Hatay Mustafa Kemal U 2
• Status: Completed
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: October 30, 2022

Study information

• Verified date: May 2024
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 on dialysis.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: October 30, 2022
• Est. primary completion date: October 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Exercise Capacity
• Inspiratory Muscle Training
• Kidney Diseases
• Renal Insufficiency, Chronic
• Respiratory Aspiration

Intervention

Other:
• 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

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inspiratory muscle strength	A mouth pressure device will be used to evaluate IMS.	First day
Secondary	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.	First day
Secondary	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.	First day
Secondary	Expiratory muscle strength	A mouth pressure device will be used to evaluate EMS.	First day
Secondary	Pulmonary functions FEV1	Spirometry will be used to assess pulmonary function.	First day
Secondary	Pulmonary functions FVC	Spirometry will be used to assess pulmonary function.	First day
Secondary	Pulmonary functions FEV1/FVC	Spirometry will be used to assess pulmonary function.	First day
Secondary	Pulmonary functions PEF	Spirometry will be used to assess pulmonary function.	First day
Secondary	Pulmonary functions FEF25-75%	Spirometry will be used to assess pulmonary function.	First day
Secondary	Dyspnoea	Dyspnoea will be measured using the Modified Medical Research Council (MMRC) dyspnoea scale. Levels of dyspnea are graded 0-4.	First day
Secondary	Fatigue	Fatigue will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 0 to 7.	First day
Secondary	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.	First day
Secondary	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.	First day
Secondary	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.	First day