Fatigue Clinical Trial
Official title:
Electrical Muscle Stimulation Versus Resistive Training On Physical Measures, And Fatigue In Hemodialysis Patients
The aim of this study is to compare effect of intradialytic NMES versus resistive training on physical measures and fatigue in HDP.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | July 30, 2024 |
Est. primary completion date | May 30, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 40 Years to 55 Years |
Eligibility | Inclusion Criteria: - Patients of both sexes, with CKF on HD for more than 3 years. - Age between 40 to 55 years old. - BMI is between 25 and 29.9 kg/m2. Exclusion Criteria: Patients who have one of the following contraindications to the interventions or affect the results - Cognitive impairment that prevented them from performing the evaluations and who were unable to understand and sign the written informed consent. - Stroke - Smokers - Anemic patients - Osteoarticular or disabling musculoskeletal disorders - Uncontrolled hypertension (systolic blood pressure>230 mm Hg and diastolic blood pressure>120 mm Hg) - Patients with coronary artery disease or heart failure. - Diabetic patients - Infectious diseases and chest diseases - Active smokers' patients with peripheral vascular disease in the lower limbs such as deep vein thrombosis or thromboangiitis |
Country | Name | City | State |
---|---|---|---|
Egypt | Outpatient clinic faculty of physical therapy cairo university | Dokki |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessing the change in maximal strength of quadriceps and calf muscles | By using a Hand held dynamometer: A Kern-type standardized traction dynamometer (Kern CH50 50KG dynamometer) will used to assess the maximal strength of quadriceps and calf muscles will estimate. The patient will remain seated in a fixed chair so the back will supported on the back rest with the hip and knee at 90°, the subject will be asked to exert the greatest possible force without holding the chair with his/her arms,the values of muscular strength variables will be the mean of 3 consecutive measurements obtained by the same investigator to minimize errors | at baseline and after 16 weeks of intervention | |
Primary | Assessing the change in predicted peak vo2 max | By using a 6-minute walk test (6MWT): It consisted of measuring the maximum distance covered during a 6 min period at an active pace, along a 20 m corridor near the HD unit. At the end of the test period, the total distance travelled was recorded by means of a standardized odometer,that will be used to calculate predicted peak vo2 by using the following equation Mean Peak VO2( ml /kg/min)= 4. 948+ 0. 023*Mean 6 MWD (meters) (SEE 1.1 ml/ kg/ min), standard error of estimate (SEE). | at baseline and after 16 weeks of intervention | |
Secondary | Assessing the change in physical and psychological fatigue | Chalder Fatigue Questionnaire (CFQ11): is a short questionnaire, phrased in simple English with a straightforward answering system, it provides a brief tool to measure both physical and psychological fatigue. It consists from 11 items are answered on a 4-point scale ranging from the asymptomatic to maximum symptomology, a score of 0, increasing to 1, 2 or 3 as they become more symptomatic. The respondent's global score can range from 0 to 33. The global score also spans two dimensions physical fatigue (measured by items 1-7) and psychological fatigue (measured by items 8-11) | at baseline and after 16 weeks of intervention | |
Secondary | Assessing the change in Dialysis efficiency | At baseline and 16 weeks after the intervention, blood samples will be collected after at least 12 h of fasting, and before the HD session, from an antecubital vein via venipuncture. Dialysis efficiency (represented using Kt/V) will be calculated from body weight and blood urea nitrogen (BUN) levels before and after dialysis using the Daugirdas formula as follows. Single-pool Kt/V will be calculated monthly using urea kinetic modeling equations derived from the following equation: (post: pre-dialysis plasma BUN ratio to estimate k. T/v and npcr: mathematical modeling) (second-generation logarithmic estimates of single-pool variable volume kt/v: an analysis of error). Kt/V = - ln(R - 0.008 × t) + [(4-3.5 × R) × UF/W], where R is the ratio of post-dialysis to pre-dialysis serum BUN concentration, t is the duration of hemodialysis in hours, UF is the amount of ultrafiltration (in l) during the HD session, and W is the post-dialysis weight (in kg). | at baseline and after 16 weeks of intervention |
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