Dialysis; ComplicationsNCT05382468
Effectiveness of Intradialytic Exercise on Reduction in Fatigue and Muscle Cramps
A study testing Intradialytic exercise in people with Dialysis; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Dialysis; Complications
- What is being tested?
- Intradialytic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteIndia
- Study dates
- 1 Nov 2021to 5 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The inclusion criteria for the present study is given below
- Patient with CKD undergoing maintenance hemodialysis,
- Age 18 years or older .
- Those who can understand English / Hindi .
- Are willing to participate in the study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
India1 site
Institute of Liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
About this study
Official title: 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.
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
Read more
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:
- To find out the association of mean fatigue score with demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
- To find out the association of mean muscle cramps score with the demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
- To find out the association of mean muscle strength score with demographic variables \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
Read the detailed description
OPERATIONAL DEFINITIONS Effectiveness: It refers to the degree to which something is successful in producing a desired result (Oxford Dictionaries 2018). In this study it refers to the significant reduction in fatigue \& muscle cramps \& improvement in muscle strength after intradialytic exercise among patients undergoing maintenance hemodialysis.
Intradialytic exercise: Intradialytic exercise is the exercise performed actively and passively of the affected muscles pertaining at the end of second a hour of hemodialysis.(Sharman 2006). 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.
Fatigue: Fatigue is a feeling of weariness, tiredness, or lack of energy.( medline plus ). In this study 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.
Muscle Cramps: A muscle cramp is a strong, painful contraction or tightening of a muscle that comes on suddenly and lasts from a few seconds to several minutes. It often occurs in the lower extremities ( Matthew Varacallo,2020). In this study 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.
Muscle strength: Muscle strength refers to the amount of force a muscle can produce with a single maximal effort.(Jennifer R. Scott ,Heather Black , March 19, 2020),In the current study , 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 .
Maintenance hemodialysis: Medical procedure to remove fluid \& waste products from the blood and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer, also referred to as an "artificial kidney ( William C. Shiel Jr. ,2017).
In this study Dialysis is helps the body by performing the functions of failed kidneys, here Maintenance Hemodialysis refers to the procedure of removal of fluids and waste products using dialysis machine outside the body the body of patients with chronic kidney disease. Patients: A person who is under medical care or treatment.( Thesaurus.com2013) In this study a patients is a person diagnosed to have End stage kidney disease/Chronic kidney disease \& undergoing maintenance hemodialysis at dialysis unit of ILBS, New Delhi.
Assumption This Study is based on following assumption;
- Patients undergoing maintenance hemodialysis may experience fatigue, muscle cramps \& poor muscle strength.(Tae-Du jung ,2011)
- Muscle cramps will limit a patient's ability to tolerate the complete session of haemodialysis.(Putri Nurftriani,2020)
- Intradialytic exercise may help in reduction of fatigue and muscle cramps and improve the muscle strength .(stavroula Ouzouni 2009)
- Sample is the true representation of the population.
Hypotheses All hypothesis will be tested at 0.05 level of significance. H1 : There is a significant difference between Mean Fatigue among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H2 : There is a significant difference between Mean Muscle Cramps among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H3 : There is a significant difference between Mean Muscle Strength among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H4 : There is a significant association of Mean Fatigue score with selected demographical \& clinical variables of patients undergoing maintenance hemodialysis .
H5 : There is a significant association of Mean Muscle Cramps score with selected demographical \& clinical variables of patients undergoing maintenance hemodialysis .
H6 : There is a significant association between Mean Muscle Strength score with demographical \& clinical variable of patients undergoing maintenance hemodialysis Development and Description of Tools Tools were prepared on an extensive review of books, journals, articles, experts opinion and investigators personal experience. For the selection and preparation of tools, the following steps were taken
- Planning for required tools.
- An extensive review of tools is done to decide upon the instrument.
- Requirement of the tools according to objectives and conceptual framework were sought.
- A formal observation in the concerned area of the study.
- Discussion with guides, peer group.
- Opinions taken from experts in the field to determine the appropriateness of the items.
The tools used in the current study are further described in detail:
Tool I Subject Data Sheet This tool is designed by principal investigator under the guidance of guide and experts to assess demographic and clinical characteristics of the patients undergoing maintenance of hemodialysis.
Description The tool was further divided into section A and section B. Section A comprises questions to assess demographic characteristics and section B includes questions to assess the clinical characteristics of the patients. (Appendix A).
Section A: Demographic characteristics It consists of seven items which includes Age, Gender, Marital status, Education, Occupation, Duration of dialysis treatment, Nature of activity, Presence of co morbid, Duration of dialysis treatment ,distance travel to reach hospital for dialysis, companies during visit hospital for dialysis,Duration of renal failure/ESRD in years.
Section B: Clinical characteristics It consists of 11 items such as BP, Pulse rate, Respiratory rate, Height, Weight, outpatient, Presence of any comorbidity,
- Conditions
- Dialysis; Complications
- Being tested
- Intradialytic exercise
- Keywords
- Hemodialysis, Intradialytic Exercise, Fatigue, Muscle Cramps, Muscle Strength
- Medical subject headings
- Fatigue, Muscle Cramp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intradialytic exerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Intradialytic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 .
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start1 Nov 2021
- Primary completion14 Nov 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis; ComplicationsStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Monalisa Ms Mohapatra, Nursing, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382468
- Sponsor's protocol ID
- IDE-107
- Status last verified
- Mar 2021
- First submitted
- 16 May 2022
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05382468
- Acronym / sponsor ID
- IDE-107
- Conditions
- Dialysis; Complications
- Keywords
- Hemodialysis, Intradialytic Exercise, Fatigue, Muscle Cramps, Muscle Strength
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 14 Nov 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To find out the association of mean fatigue score with demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
- To find out the association of mean muscle cramps score with the demographic \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
- To find out the association of mean muscle strength score with demographic variables \& clinical variables of patients undergoing maintenance hemodialysis after intradialytic exercise.
Detailed description
OPERATIONAL DEFINITIONS Effectiveness: It refers to the degree to which something is successful in producing a desired result (Oxford Dictionaries 2018). In this study it refers to the significant reduction in fatigue \& muscle cramps \& improvement in muscle strength after intradialytic exercise among patients undergoing maintenance hemodialysis.
Intradialytic exercise: Intradialytic exercise is the exercise performed actively and passively of the affected muscles pertaining at the end of second a hour of hemodialysis.(Sharman 2006). 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.
Fatigue: Fatigue is a feeling of weariness, tiredness, or lack of energy.( medline plus ). In this study 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.
Muscle Cramps: A muscle cramp is a strong, painful contraction or tightening of a muscle that comes on suddenly and lasts from a few seconds to several minutes. It often occurs in the lower extremities ( Matthew Varacallo,2020). In this study 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.
Muscle strength: Muscle strength refers to the amount of force a muscle can produce with a single maximal effort.(Jennifer R. Scott ,Heather Black , March 19, 2020),In the current study , 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 .
Maintenance hemodialysis: Medical procedure to remove fluid \& waste products from the blood and to correct electrolyte imbalances. This is accomplished using a machine and a dialyzer, also referred to as an "artificial kidney ( William C. Shiel Jr. ,2017).
In this study Dialysis is helps the body by performing the functions of failed kidneys, here Maintenance Hemodialysis refers to the procedure of removal of fluids and waste products using dialysis machine outside the body the body of patients with chronic kidney disease. Patients: A person who is under medical care or treatment.( Thesaurus.com2013) In this study a patients is a person diagnosed to have End stage kidney disease/Chronic kidney disease \& undergoing maintenance hemodialysis at dialysis unit of ILBS, New Delhi.
Assumption This Study is based on following assumption;
- Patients undergoing maintenance hemodialysis may experience fatigue, muscle cramps \& poor muscle strength.(Tae-Du jung ,2011)
- Muscle cramps will limit a patient's ability to tolerate the complete session of haemodialysis.(Putri Nurftriani,2020)
- Intradialytic exercise may help in reduction of fatigue and muscle cramps and improve the muscle strength .(stavroula Ouzouni 2009)
- Sample is the true representation of the population.
Hypotheses All hypothesis will be tested at 0.05 level of significance. H1 : There is a significant difference between Mean Fatigue among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H2 : There is a significant difference between Mean Muscle Cramps among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H3 : There is a significant difference between Mean Muscle Strength among patients undergoing maintenance hemodialysis before and after intradialytic exercise.
H4 : There is a significant association of Mean Fatigue score with selected demographical \& clinical variables of patients undergoing maintenance hemodialysis .
H5 : There is a significant association of Mean Muscle Cramps score with selected demographical \& clinical variables of patients undergoing maintenance hemodialysis .
H6 : There is a significant association between Mean Muscle Strength score with demographical \& clinical variable of patients undergoing maintenance hemodialysis Development and Description of Tools Tools were prepared on an extensive review of books, journals, articles, experts opinion and investigators personal experience. For the selection and preparation of tools, the following steps were taken
- Planning for required tools.
- An extensive review of tools is done to decide upon the instrument.
- Requirement of the tools according to objectives and conceptual framework were sought.
- A formal observation in the concerned area of the study.
- Discussion with guides, peer group.
- Opinions taken from experts in the field to determine the appropriateness of the items.
The tools used in the current study are further described in detail:
Tool I Subject Data Sheet This tool is designed by principal investigator under the guidance of guide and experts to assess demographic and clinical characteristics of the patients undergoing maintenance of hemodialysis.
Description The tool was further divided into section A and section B. Section A comprises questions to assess demographic characteristics and section B includes questions to assess the clinical characteristics of the patients. (Appendix A).
Section A: Demographic characteristics It consists of seven items which includes Age, Gender, Marital status, Education, Occupation, Duration of dialysis treatment, Nature of activity, Presence of co morbid, Duration of dialysis treatment ,distance travel to reach hospital for dialysis, companies during visit hospital for dialysis,Duration of renal failure/ESRD in years.
Section B: Clinical characteristics It consists of 11 items such as BP, Pulse rate, Respiratory rate, Height, Weight, outpatient, Presence of any comorbidity,
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intradialytic exercise | Experimental | Other: Intradialytic exerciseIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- The inclusion criteria for the present study is given below
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intradialytic exerciseIntradialytic 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 |
Primary outcome
Fatigue
Time frame: up to 4 weeks
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.
Muscle Cramps
Time frame: up to 4 weeks
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.
Muscle Strength
Time frame: up to 4 weeks
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 .
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Monalisa Ms Mohapatra, Nursing principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intradialytic exercise in people with Dialysis; Complications, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue (time frame: up to 4 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2022.