NCT04958759

Brief Summary

Effects of functional inspiratory muscle training by telerehabilitation on respiratory and peripheral functions, functional capacity, diaphragm thickness and mobility, posture, quality of life, cognitive function, fatigue, physical activity, endothelial function and aortic stiffness in patients with chronic kidney disease will be investigated.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 12, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 9, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 3, 2023

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

1.5 years

First QC Date

May 12, 2021

Last Update Submit

August 11, 2023

Conditions

Keywords

Respiratory muscle

Outcome Measures

Primary Outcomes (8)

  • Respiratory muscle strength

    Respiratory muscle strength will be evaluated using mouth pressure device

    10 minutes

  • Respiratory muscle endurance

    Respiratory muscle endurance will be evaluated using incremental load test

    10 minutes

  • Pulmonary function

    Pulmonary functions will be evaluated using spirometry

    5 minutes

  • Peripheral muscle strength

    Peripheral muscle strength will be evaluated using dynamometer

    5 minutes

  • Endurance of trunk muscles

    Endurance of trunk muscles will be evaluated using plank, side plank, flexor endurance and pelvic bridge test

    10 minutes

  • Lower extremity muscle endurance

    Lower extremity muscle endurance will be evaluated using sit-to-stand test

    1 minutes

  • Functional capacity

    Functional capacity will be evaluated using six-minute walk test

    10 minutes

  • Diaphragm thickness and mobility

    Diaphragm thickness and mobility will be evaluated using ultrasonography

    20 minutes

Secondary Outcomes (9)

  • Balance

    5 minutes

  • Static balance

    5 minutes

  • Posture

    5 minutes

  • Qol

    10 minutes

  • Cognitive function

    5 minutes

  • +4 more secondary outcomes

Study Arms (3)

Functional Inspiratory Muscle Training Group

EXPERIMENTAL

Functional inspiratory muscle training in patients with chronic kidney disease

Other: Functional Inspiratory Muscle TrainingOther: Inspiratory Muscle Training

Inspiratory Muscle Training Group

EXPERIMENTAL

Inspiratory muscle training in patients with chronic kidney disease

Other: Inspiratory Muscle Training

Control Group

EXPERIMENTAL

Breathing exercises in patients with chronic kidney disease

Other: Breathing exercises

Interventions

The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training

Functional Inspiratory Muscle Training Group

The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training

Functional Inspiratory Muscle Training GroupInspiratory Muscle Training Group

The program will be consist of 10 weeks of breathing exercises

Control Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with chronic kidney disease not receiving dialysis
  • Access to the online program
  • Volunteering to participate in the research

You may not qualify if:

  • Having a musculoskeletal problem
  • Having decompensated diabetes
  • Having uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University, Faculty of Physical Therapy and Rehabilitation

Ankara, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Merve Firat, MSc

    Hacettepe University

    PRINCIPAL INVESTIGATOR
  • Naciye Vardar-Yagli, PhD

    Hacettepe University

    STUDY DIRECTOR
  • Tolga Yildirim, MD

    Hacettepe University

    STUDY DIRECTOR
  • Deniz İnal-İnce, Professor

    Hacettepe University

    STUDY CHAIR
  • Melda Saglam, PhD

    Hacettepe University

    STUDY CHAIR
  • Ebru Calik-Kutukcu, PhD

    Hacettepe University

    STUDY CHAIR
  • Ahmet Hakan Ates, MD

    Hacettepe University

    STUDY CHAIR
  • Selin Ardali-Duzgun, MD

    Hacettepe University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

May 12, 2021

First Posted

July 12, 2021

Study Start

March 1, 2021

Primary Completion

September 9, 2022

Study Completion

May 3, 2023

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations