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

Not Applicable

Completed

• Conditions: Inspiratory Muscle Training; Chronic Kidney Diseases; Exercise Capacity

• Registration Number: NCT06401135
• Lead Sponsor: Mustafa Kemal University

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.

Study Timeline

• Study Start: 2021-07-28
• Primary Completion: 2022-10-30
• Study Completion: 2022-10-30
• Study First Submitted: 2024-04-30
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-02
• Last Update Submitted: 2024-05-02
• Study First Posted: 2024-05-06
• Last Update Posted: 2024-05-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inspiratory muscle strength	First day	A mouth pressure device will be used to evaluate IMS.

Secondary Outcome Measures

Name	Time	Method
Pulmonary functions FVC	First day	Spirometry will be used to assess pulmonary function.
Expiratory muscle strength	First day	A mouth pressure device will be used to evaluate EMS.
Dyspnoea	First day	Dyspnoea will be measured using the Modified Medical Research Council (MMRC) dyspnoea scale. Levels of dyspnea are graded 0-4.
Fatigue	First day	Fatigue will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 0 to 7.
Peripheral muscle strength	First day	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.
Pulmonary functions FEF25-75%	First day	Spirometry will be used to assess pulmonary function.
Pulmonary functions FEV1	First day	Spirometry will be used to assess pulmonary function.
Pulmonary functions FEV1/FVC	First day	Spirometry will be used to assess pulmonary function.
Functional exercise capacity	First day	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.
Pulmonary functions PEF	First day	Spirometry will be used to assess pulmonary function.
Quality of life assessment	First day	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.
Physical activity	First day	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.
Balance	First day	Balance will be evaluated using the Berg Balance Scale (BBS). The scale includes 14 items scoring 0 to 4. Higher scores indicate better balance.

Trial Locations

Locations (1)

Hatay Mustafa Kemal University; 🇹🇷 Hatay, Turkey