The objective of this study will be to evaluate the effects of quadriceps muscle activation with neuromuscular electrical stimulation in patients with congestive heart failure.
Design
Two parallel groups, double-blinded, Randomized Controlled Trial with pre and post-assessment. Sample size will be 54.
Settings and conduct
The data will be collected from Gulab Devi Hospital, Lahore.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
• 45-60 years of age
• Congestive Heart Failure patients
• Forced expiratory volume in 1 second (FEV1) less than 50% predicted
• Incapacitating breathlessness (Medical Research Council dyspnoea scale ≥4)
• Diagnosed CHF patients
Exclusion Criteria:
• Neuromuscular or neurological disorders
• Severe arthrosis or other musculoskeletal limitations
• Implanted cardiac pacemaker
• Knee osteoarthritis, Rheumatoid arthritis
• Any inflammation in knee
• Peripheral Neuropathy
• Diagnosis of cancer
• Acute exacerbation requiring hospital admission or systemic corticosteroids in the preceding 4 weeks.
Intervention groups
Group A will receive Neuro Mnuscular Electrical Stimulation therapy, and Group B will undergo traditional strength training and NMES, with both groups following standardized protocols for the same duration and frequency of sessions.
Main outcome variables
Maximal Voluntary Contraction (MVC) on the quadriceps muscles of patients by using a dynamometer.
Left Ventricular Ejection Fraction (LVEF) will be assessed through echocardiography.
The Rate of Perceived Exertion (RPE).
Functional Capacity Evaluation (FCE) will be assessed by 6-min Walk Test (6MWT).
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191117045462N22
Registration date:2024-08-06, 1403/05/16
Registration timing:prospective
Last update:2024-08-06, 1403/05/16
Update count:0
Registration date
2024-08-06, 1403/05/16
Registrant information
Name
Wajeeha Zia
Name of organization / entity
Riphah International University
Country
Pakistan
Phone
+92 42 35126110
Email address
wajeeha_z@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-15, 1403/05/25
Expected recruitment end date
2024-12-15, 1403/09/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of Quadriceps muscle activation with Neuromuscular Electrical Stimulation in patients with Congestive heart failure
Public title
Effects of Quadriceps muscle activation with Neuromuscular Electrical Stimulation in patients with Congestive heart failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
45-60 years of age
Congestive Heart Failure patients
Forced expiratory volume in 1 second (FEV1) less than 50% predicted
Incapacitating breathlessness (Medical Research Council dyspnoea scale ≥4)
Diagnosed CHF patients
Exclusion criteria:
Neuromuscular or neurological disorders
Severe arthrosis or other musculoskeletal limitations
Implanted cardiac pacemaker
Knee osteoarthritis, Rheumatoid arthritis
Any inflammation in knee• Peripheral Neuropathy
Diagnosis of cancer
Acute exacerbation requiring hospital admission or systemic corticosteroids in the preceding 4 weeks .
Age
From 45 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly allocated to Group A or Group B through a simple randomization process using sealed opaque envelopes labeled as 0 for Group A and 1 for Group B.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double blinded. The assessor physiotherapist and the patient both will be double blinded.
Although the consent form will be taken from the patient. But the patient will not be aware of the study. Accessor physiotherapist will be involved in the study. He will access the patient by defined outcome measure tools before the start of the study at the end.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Riphah college of rehabilitation & Allied Health Sciences
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Approval date
2024-07-16, 1403/04/26
Ethics committee reference number
RCS&AHS/REC/MS-CPPT
Health conditions studied
1
Description of health condition studied
Congestive Heart Failure
ICD-10 code
ICD-10 code description
Systolic (congestive) heart failure
Primary outcomes
1
Description
Maximal Voluntary Contraction (MVC)
Timepoint
Pre- Post Treatment
Method of measurement
Dynamometer
2
Description
Left Ventricular Ejection Fraction (LVEF)
Timepoint
Pre- Post Treatment
Method of measurement
Echocardiography
3
Description
The intensity of exercise
Timepoint
Pre- Post Treatment
Method of measurement
The Rate of Perceived Exertion (RPE)
4
Description
Functional Capacity
Timepoint
Pre- Post Treatment
Method of measurement
6-min Walk Test (6MWT)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Neuromuscular Electrical Stimulation (NMES); For NMES therapy, electrodes will be strategically placed on the quadriceps muscles, with sessions lasting 30 minutes, conducted three times per week. The NMES intensity will be adjusted to achieve strong but comfortable contractions during each session.
Category
Rehabilitation
2
Description
Control group: Participants will participate in a comprehensive strength training regimen that will undergo Neuro Muscular Electrical Stimulation and traditional strength training.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Gulab Devi Hospital, Lahore.
Full name of responsible person
Maheera Khalid
Street address
F8MV+5HW, Ferozepur Rd
City
Lahore
Postal code
05307
Phone
+92 337 7407559
Email
maheerakhalid0899@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Grant name
Nil
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Riphah International University
Proportion provided by this source
15
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Maheera Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Royal Garden Harbanspura, Lahore
City
Lahore
Province
Punjab
Postal code
54850
Phone
+92 337 7407559
Email
maheerakhalid0899@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Wajeeha Zia
Position
Senior Lecturer
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
25 Raza Saeed Rd, Bhabra Block M Gulberg III, Lahore, Punjab 25-M Block, Lahore
City
Lahore
Province
Punjab
Postal code
54660
Phone
+92 42 111 747 424
Email
wajeeha_z@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Riphah International University
Full name of responsible person
Maheera Khalid
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
St#13 Royal garden, Harbanspura
City
Lahore
Province
Punjab
Postal code
54850
Phone
+92 337 7407559
Email
maheerakhalid0899@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available