- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07292311
Reliability of Muscle Strength and Activation Assessment Tools and Effects of an Online Therapeutic Exercise Program in Patients With Chronic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients with chronic kidney disease experience progressive muscle weakness and reduced physical capacity due to systemic inflammation, metabolic acidosis, and inactivity.
This two-phase observational and interventional study, conducted in collaboration with the ALCER Association (Badajoz and Cáceres, Spain), will:
- Determine the test-retest reliability of muscle assessment tools (isokinetic dynamometer, surface electromyography, and handheld dynamometry).
- Implement and evaluate an online therapeutic exercise program supervised by physiotherapists.
The project aims to provide valid and reliable protocols for neuromuscular assessment in CKD patients and explore the feasibility of remote therapeutic exercise.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Cáceres
-
Cáceres, Cáceres, Spain, 10003
- Facultad de Enfermería y Terapia Ocupacional
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ≥18 years old.
- Diagnosis of chronic kidney disease (hemodialysis, peritoneal dialysis, or kidney transplant).
- Member of ALCER Association (Badajoz or Cáceres).
- Medical clearance for physical testing/exercise.
Exclusion Criteria:
- Severe cognitive or communication impairment.
- Unstable cardiovascular or musculoskeletal conditions.
- Refusal to provide informed consent.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Reliability Assessment
Test-retest reliability of isokinetic and surface EMG measurements in upper limb, trunk, and lower limb
|
Device: Isokinetic dynamometer and mDurance® surface EMG Test-retest reliability of isokinetic and surface EMG measurements in upper limb, trunk, and lower limb
|
|
Experimental: Online Therapeutic Exercise
8-10 week supervised online program including resistance and mobility exercises
|
Behavioral: Online therapeutic exercise program 8-10 week supervised online program including resistance and mobility exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Test-retest reliability of surface EMG (Electromiography) activation.
Time Frame: 7-10 days
|
RMS (root mean square).
microvolts
|
7-10 days
|
|
Test-retest reliability of isokinetic strength
Time Frame: 7-10 days
|
Intraclass Correlation Coefficient - ICC. Strength (kilograms)
|
7-10 days
|
|
Change in handgrip and limb strength measured by VALD dynamometry
Time Frame: Baseline and 12 weeks
|
strength (kilograms)
|
Baseline and 12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Musculoskeletal Diseases
- Nervous System Diseases
- Muscular Diseases
- Neuromuscular Manifestations
- Pathologic Processes
- Male Urogenital Diseases
- Pathological Conditions, Anatomical
- Kidney Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Chronic Disease
- Disease Attributes
- Renal Insufficiency
- Muscular Atrophy
- Atrophy
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Muscle Weakness
- Sarcopenia
- Renal Insufficiency, Chronic
Other Study ID Numbers
- 071125
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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