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Effects of Exercise Program on Physical Functioning of Hemodialysis Patients.

Effects of Home-based Exercise Program on Physical Functioning of Hemodialysis Patients.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04674930
Enrollment
26
Registered
2020-12-19
Start date
2019-09-25
Completion date
2021-01-20
Last updated
2021-05-06

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

Conditions

Hemodialysis Patients

Keywords

Chronic kidney disease, Hemodialysis, Home-based exercise plan

Brief summary

This study is designed to provide a simple, home-based, low-moderate intensity exercise program in chronic renal disease patients who are undergoing hemodialysis in order to improve physical performance, decrease the level of fatigue and eventually increase quality of life in patients. A randomized control trial will be conducted including patients on hemodialysis, who will be randomly allocated to interventional and control groups. Both the groups will receive six weeks of treatment, 3 times per week. Data will be collected at baseline, 3rd week and 6th week. Outcome measures include assessment of physical functioning including six-minute walk test, standing balance, 4-metre gait speed, chair stand, fatigue assessment scale and quality of life in kidney disease patients on hemodialysis.

Detailed description

Chronic Kidney Disease (CKD) is defined as the structural and functional abnormalities of kidney along with decreased Glomerular Filtration Rate (GFR) \< 60 ml/min/1.73 m2 for 3 months. It also refers to an irreversible deterioration in renal function that usually develops over a period of years it represents not only as a biochemical abnormality but, eventually, loss of the excretory, metabolic and hormonal functions of the kidney which leads to the clinical symptoms and signs of renal failure. The alarmingly high prevalence of reduced GFR in adult men and women in Pakistan is not unexpected as the prevalence of risk factors of CKD including hypertension and diabetes is one of the highest reported worldwide. The prevalence rate of CKD is found to be 70% in Pakistan. Clinical sign of raised urea and creatinine should be found during routine blood tests. An early symptom is nocturia, tiredness or breathlessness, renal anemia or fluid overload, pruritus, anorexia, weight loss, nausea, vomiting and hiccups. In very advanced (chronic stage) renal failure, respiration may be particularly deep (Kussmaul breathing), metabolic acidosis, and patients may develop muscular twitching, fits, drowsiness and coma. Chronic kidney disease can be managed by lifestyle modifications (dietary management, weight management, physical activity) are the initial components of treatment. Blockade of the renin angiotensin aldosterone system, blood pressure control, optimally managed comorbid diabetes and avoidance of nephrotoxic medications to prevent worsening renal function are also part of management. Hemodialysis is a medical procedure to remove the waste products in the form of fluid from the blood and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer, also referred to as an artificial kidney. As dialysis requires patients to be seated for extended periods of time, the risk of developing obesity, high blood pressure, decreased quality of life, musculoskeletal problems, such as low back pain and muscle tightness is higher than normal. The physiotherapeutic exercise program during hemodialysis improves the quality of life (QOL) of chronic renal patients in physical, social, environmental and psychological. On regular basis physiotherapy intervention is to a lower frequency of edema and muscle cramps and to reduce the intensity of pain. It also influences the improvement of the respiratory function, showed by the evolution of the values maximal inspiratory pressure (IPmax), maximal expiratory pressure (EPmax) and peak expiratory flow. Studies reported that aerobic as well as strength training proved to have favorable short and long-term effects on the physical performance and the functional balance in patients on maintenance renal hemodialysis. All patients undertaking hemodialysis (HD) are recommended to exercise to some extent. Intra-dialytic resistance training program is also feasible and effective, causing improvement in physical functioning by improving the strength, exercise capacity and performance in physical tests. Patients with chronic renal failure on hemodialysis, inspiratory muscle training induces improvement in respiratory muscle strength, functional capacity, lung function and quality of life. Inspiratory muscle training can improve maximal respiratory pressures, lung function, functional capacity and quality of life in patients with chronic renal failure who are receiving hemodialysis.

Interventions

OTHERExercise program

Home based exercise program including aerobic and resistance training will be carried out for a period of 6 weeks. Duration of aerobic exercise will be starting at 20 min/session, and progress to 30 ruin/session, with an increased pace according to the patient's capabilities. Resistance training with thera-band for 1 set of 10 repetitions twice a week. One RM will be reassessed weekly, and the program will be adjusted accordingly.

Sponsors

Riphah International University
Lead SponsorOTHER

Study design

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

Eligibility

Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Patients undertaking hemodialysis sessions for last 3 months * Hemodynamically stable patients * Stable clinical and functional state for at least 4 weeks * Conscious level preserved * Stage 5, Kidney Failure (GFR \<15)

Exclusion criteria

* Patients with acute illness or infection, recent surgery, or vascular intervention * Hospitalized within past 4 weeks (with dialysis or non-dialysis reasons) * Uncontrolled Hypertension * Patients with difficulty walking, without a walking aid owing to orthopedic problems * Patients with neurological, musculoskeletal, cardiac and pulmonary disease and physical impairment

Design outcomes

Primary

MeasureTime frameDescription
Change in Six minute Walk test3 and 6 weeks of interventionThis is a sub-maximal exercise test used to assess endurance and functional capacity. The distance covered in 6 minutes, is used as the outcome, by which we compare the changes in performance capacity. This test is performed in a gallery having a distance of 20m in length, in a straight line. In starting, the patient rests for 5 minutes in a sitting position, after 5 minutes the vitals will be assessed in resting phase. The patients are instructed about the test method, during one- minute intervals patients can ask about the time remaining during the test, prior to the end of the test. The distance walked in meters is then noted and functional capacity is estimated.

Secondary

MeasureTime frameDescription
Short Performance Physical Battery test (SPPB)3 and 6 weeksThe SPPB examines three subcomponents of the lower extremity's function, these are standing balance, 4-metre gait speed, and chair stand these are of essential tasks for independent living among CKD patients on hemodialysis
Fatigue Assessment Scale (FAS)3 and 6 weeksFatigue assessing scale can help in assessment of fatigue. The FAS is based on 10-item, which is used to evaluate symptoms of chronic fatigue. This is the self-reported questionnaire, measured by a notebook and pen, the time required to fulfill the self-assessment form is to take approximately 2 minutes
Kidney Disease Quality of Life - Short form (SF 36) (KDQOL-SF 36)3 and 6 weeksThe KDQOL-36 is a self-administered to assess quality of life in patients with renal diseases. It requires paper- and-pencil and takes approximately 5 minutes to be filled. It assesses quality of life with regard to different domains of health

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026