Skip to main content
OpenTrials
Completed

NCT Number: NCT06401135

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Exercise Capacity Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Inspiratory Muscle Training Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hatay Mustafa Kemal University

Hatay, 31001, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Inspiratory muscle strength

    Time frame: First day

    A mouth pressure device will be used to evaluate IMS.

Secondary outcomes

  1. Functional exercise capacity

    Time frame: 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.

  2. Peripheral muscle strength

    Time frame: 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.

  3. Expiratory muscle strength

    Time frame: First day

    A mouth pressure device will be used to evaluate EMS.

  4. Pulmonary functions FEV1

    Time frame: First day

    Spirometry will be used to assess pulmonary function.

  5. Pulmonary functions FVC

    Time frame: First day

    Spirometry will be used to assess pulmonary function.

  6. Pulmonary functions FEV1/FVC

    Time frame: First day

    Spirometry will be used to assess pulmonary function.

  7. Pulmonary functions PEF

    Time frame: First day

    Spirometry will be used to assess pulmonary function.

  8. Pulmonary functions FEF25-75%

    Time frame: First day

    Spirometry will be used to assess pulmonary function.

  9. Dyspnoea

    Time frame: First day

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

  10. Fatigue

    Time frame: First day

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

  11. Quality of life assessment

    Time frame: 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.

  12. Physical activity

    Time frame: 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.

  13. Balance

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Mustafa Kemal University

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 6, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.