Effectiveness of Intradialytic Exercise on Reduction in Fatigue and Muscle Cramps

NCT05382468 | Completed DMC

• 1 other identifier: IDE-107
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

An experimental study to assess the Effectiveness of Intradialytic exercise on reduction in Fatigue and Muscle Cramps and Improvement in Muscle Strength among CKD patients undergoing Maintenance Haemodialysis at dialysis unit of ILBS. Objectives Primary objective: 1.To evaluate the effectiveness of the intradialytic exercise on reduction in fatigue and muscle cramps and improvement in muscle strength among patients undergoing hemodialysis at dialysis unit of ILBS. Secondary objectives:

1. 1.To find out the association of mean fatigue score with demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
2. 2.To find out the association of mean muscle cramps score with the demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
3. 3.To find out the association of mean muscle strength score with demographic variables \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.

Conditions

Dialysis; Complications

Keywords

Hemodialysis; Intradialytic Exercise; Fatigue; Muscle Cramps; Muscle Strength

Outcome Measures

Primary Outcomes (3)

• Fatigue

  Fatigue is a extreme tiredness and inability to function due to lack of energy \& slowed movement among the patients undergoing maintenance haemodialysis here its assessed by FACIT-F scale.

  up to 4 weeks

• Muscle Cramps

  Muscle cramps refers to painful involuntary muscle contraction felt in the calf, gastrocnemius, soleus, hamstring and quadriceps muscles by the patients undergoing haemodialysis as assessed by Modified Penn Spasm Frequency Scale and graded into as mild, moderate, and severe cramps.

  up to 4 weeks

• Muscle Strength

  Muscle refers to amount of force of calf, gastrocnemius, soleus, hamstring and quadriceps muscles can produce with a single maximum effort as assessed by muscle power grading scale .

  up to 4 weeks

Study Arms (1)

Intradialytic exercise

EXPERIMENTAL

In this study intradialytic exercise comprised of a set warm up, aerobic, active, passive \& cool down activities performed by patients during dialysis for a period of 30 min twice or thrice a week regularly for one month \& supervised by principle investigator.

Other: Intradialytic exercise

Interventions

Intradialytic exercise OTHER

Intradialytic exercise comprised of a set warm up, aerobic, active,passive \& cool down activities performed by patients during dialysis for a period of 30 min twice or thrice a week regularly for one month \& supervised by principle investigator.

Intradialytic exercise

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patient with CKD undergoing maintenance hemodialysis,
• Age 18 years or older .
• Those who can understand English / Hindi .
• Are willing to participate in the study.

You may not qualify if:

• Patients with CKD \& maintenance hemodialysis upper and lower limb pathology such as nerve injury, vascular injury joint irritability, joint effusion.
• Patients with lower limb access for dialysis.
• Undergoing emergency dialysis.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

Location

MeSH Terms

Conditions

Fatigue; Muscle Cramp

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases

Study Officials

• Monalisa Ms Mohapatra, Nursing

  Institute of Liver and Biliary Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: May 19, 2022
• Study Start: November 1, 2021
• Primary Completion: November 14, 2021
• Study Completion: December 5, 2021
• Last Updated: May 19, 2022

Record last verified: 2021-03

Locations

IN (1)