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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
Interventions
Other: Inspiratory muscle training
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.

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
Arm && Interventions
GroupInterventionDescription
High intensity inspiratory muscle training groupInspiratory muscle trainingGroup 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.
Control groupInspiratory muscle trainingGroup 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.
Low intensity inspiratory muscle training groupInspiratory muscle trainingGroup 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.
Primary Outcome Measures
NameTimeMethod
Inspiratory muscle strengthFirst day

A mouth pressure device will be used to evaluate IMS.

Secondary Outcome Measures
NameTimeMethod
FatigueFirst day

Fatigue will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 0 to 7.

Pulmonary functions FVCFirst day

Spirometry will be used to assess pulmonary function.

Expiratory muscle strengthFirst day

A mouth pressure device will be used to evaluate EMS.

DyspnoeaFirst day

Dyspnoea will be measured using the Modified Medical Research Council (MMRC) dyspnoea scale. Levels of dyspnea are graded 0-4.

Peripheral muscle strengthFirst 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 FEV1First day

Spirometry will be used to assess pulmonary function.

Pulmonary functions FEV1/FVCFirst day

Spirometry will be used to assess pulmonary function.

Functional exercise capacityFirst 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 PEFFirst day

Spirometry will be used to assess pulmonary function.

Quality of life assessmentFirst 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 activityFirst 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.

BalanceFirst 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

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