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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06401135
Enrollment
47
Registered
2024-05-06
Start date
2021-07-28
Completion date
2022-10-30
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Diseases, Exercise Capacity, Inspiratory Muscle Training

Keywords

Chronic kidney disease, Inspiratory muscle training

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.

Interventions

OTHERInspiratory 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

Sponsors

Mustafa Kemal University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

The patients will be not informed about their groups and they will be evaluated and trained at different places and times

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Inspiratory muscle strengthFirst dayA mouth pressure device will be used to evaluate IMS.

Secondary

MeasureTime frameDescription
Peripheral muscle strengthFirst dayA 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.
Expiratory muscle strengthFirst dayA mouth pressure device will be used to evaluate EMS.
Pulmonary functions FEV1First daySpirometry will be used to assess pulmonary function.
Pulmonary functions FVCFirst daySpirometry will be used to assess pulmonary function.
Pulmonary functions FEV1/FVCFirst daySpirometry will be used to assess pulmonary function.
Pulmonary functions PEFFirst daySpirometry will be used to assess pulmonary function.
Functional exercise capacityFirst dayFunctional 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.
DyspnoeaFirst dayDyspnoea will be measured using the Modified Medical Research Council (MMRC) dyspnoea scale. Levels of dyspnea are graded 0-4.
FatigueFirst dayFatigue will be assessed using the Fatigue Severity Scale (FSS). The total score ranges from 0 to 7.
Quality of life assessmentFirst dayThe 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 dayPhysical 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 dayBalance will be evaluated using the Berg Balance Scale (BBS). The scale includes 14 items scoring 0 to 4. Higher scores indicate better balance.
Pulmonary functions FEF25-75%First daySpirometry will be used to assess pulmonary function.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026