Cardiovascular DiseasesNCT06319651
Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation
A study testing Lower Limb Resistance Band Exercises and Routine Phase 1 cardiac rehabilitation in people with Cardiovascular Diseases, run by Riphah International University at 1 site in Pakistan.
Trial summary
This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Lower Limb Resistance Band Exercises and Routine Phase 1 cardiac rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 15 Jun 2024
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 35 to 60
- Female and Male both
- Hemodynamic stable patients
- Arrhythmias or angina not present
- Post elective sternotomy surgery
- Post extubating
Who cannot join
- Chronic obstructive pulmonary disease
- Neurological Sequelae
- Neuromuscular disease
- Emergency or off pump surgery
- Surgical re-intervention
- Patient who remained on mechanical ventilation longer than 24 hours
- Patient who had a baseline partial pressure of oxygen (PaO2) less than 75 mmHg and partial pressure of carbon dioxide (PCO2) 45 mmHg
- Patients who had history of respiratory tract infection within a period of three months
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Rehmatul lil Alameen Institute of cardiology
Lahore, Punjab Province, 42000
About this study
Official title: Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation on Functional Recovery Among Post Coronary Artery Bypass Grafting Patients
This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Read the detailed description
This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Descriptive analysis will be applied. Data will be collected from Rehmatul lil Alameen Institute of cardiology Lahore. Sample size will be 56, 28 in each group. In addition to the routine Phase 1 cardiac rehabilitation for experimental group the exercise protocol consisted of 10 minutes of warm up, elastic band strength exercise protocol (30 minutes) and cool down (5 minutes) so that an exercise session lasted about 45-50 minutes, exercise will performed circularly 2 sets, 10 repetition with a 2 minute rest after each cycle and monitored the performance of exercise for 6 days. Resisted band exercise are Extending thighs, Closing thighs, Opening thighs, Bending thighs, Dorsiflexion, Plantarflexion. For control group routine Phase 1 cardiac rehabilitation only. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
- Conditions
- Cardiovascular Diseases
- Being tested
- Lower Limb Resistance Band Exercises, Routine Phase 1 cardiac rehabilitation
- Keywords
- Coronary artery bypass grafting, Cardiac rehabilitation, Resistance band exercise
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lower Limb Resistance Band ExercisesOther
- Extending thighs
- Closing thighs
- Opening thighs
- Bending thighs
- Bending ankles
- Ankle opening
Routine Phase 1 cardiac rehabilitationOther
Routine Phase 1 cardiac rehabilitation only.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | In addition to the routine Phase 1 cardiac rehabilitation, Resistance Exercises
* Extending thighs
* Closing thighs
* Opening thighs
* Bending thighs
* Bending ankles
* Ankle opening Receives: Other: Lower Limb Resistance Band Exercises; Other: Routine Phase 1 cardiac rehabilitation |
| Routine Phase 1 cardiac rehabilitation | Active comparator | Routine Phase 1 cardiac rehabilitation only. Receives: Other: Routine Phase 1 cardiac rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Independence Measure
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition.
Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program.
Uses the level of assistance an individual needs to grade functional status from total independence to total assistance).
The tool is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention.
FIM 3 levels.
Measured: 6 Days
6 Minute Walk Test
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Measured: 6 Days
Forced expiratory volume (FEV1)
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry
Measured: 6 Days
Forced vital capacity (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry
Measured: 6 Days
FEV1/FVC ratio
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85. It's measured by spirometry
Measured: 6 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start1 Mar 2024
- Primary completion5 Jun 2024
- Study completion15 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial (RCT). Pre \& Post data collection
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Faizan Hamid, Ms-CPPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319651
- Sponsor's protocol ID
- REC/RCR&AHS/23/0360
- Status last verified
- Jul 2024
- First submitted
- 4 Mar 2024
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Lower Limb Resistance Band Exercises in Phase 1 Cardiac Rehabilitation on Functional Recovery Among Post Coronary Artery Bypass Grafting Patients
- ClinicalTrials.gov ID
- NCT06319651
- Acronym / sponsor ID
- REC/RCR&AHS/23/0360
- Conditions
- Cardiovascular Diseases
- Keywords
- Coronary artery bypass grafting, Cardiac rehabilitation, Resistance band exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 5 Jun 2024 (actual)
- Study completion
- 15 Jun 2024 (actual)
- First posted
- 20 Mar 2024 (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.
This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Sample size will be 56, 28 in each group. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Detailed description
This study will be randomized controlled trial with non-probability purposive sampling. Study conducted among post CABG patients. Descriptive analysis will be applied. Data will be collected from Rehmatul lil Alameen Institute of cardiology Lahore. Sample size will be 56, 28 in each group. In addition to the routine Phase 1 cardiac rehabilitation for experimental group the exercise protocol consisted of 10 minutes of warm up, elastic band strength exercise protocol (30 minutes) and cool down (5 minutes) so that an exercise session lasted about 45-50 minutes, exercise will performed circularly 2 sets, 10 repetition with a 2 minute rest after each cycle and monitored the performance of exercise for 6 days. Resisted band exercise are Extending thighs, Closing thighs, Opening thighs, Bending thighs, Dorsiflexion, Plantarflexion. For control group routine Phase 1 cardiac rehabilitation only. Outcome will be measured by using 6 minute walk test, Spirometry (FVC, FEV1/FVC and PEF), Functional Independence Measure.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled trial (RCT). Pre \& Post data collection
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Lower Limb Resistance Band Exercises, Other: Routine Phase 1 cardiac rehabilitationIn addition to the routine Phase 1 cardiac rehabilitation, Resistance Exercises * Extending thighs * Closing thighs * Opening thighs * Bending thighs * Bending ankles * Ankle opening |
| Routine Phase 1 cardiac rehabilitation | Active comparator | Other: Routine Phase 1 cardiac rehabilitationRoutine Phase 1 cardiac rehabilitation only. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 35 to 60
- Female and Male both
- Hemodynamic stable patients
- Arrhythmias or angina not present
- Post elective sternotomy surgery
Key exclusion criteria (8 listed)
- Chronic obstructive pulmonary disease
- Neurological Sequelae
- Neuromuscular disease
- Emergency or off pump surgery
- Surgical re-intervention
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 |
|---|---|---|
| Lower Limb Resistance Band Exercises* Extending thighs * Closing thighs * Opening thighs * Bending thighs * Bending ankles * Ankle opening | Other | Experimental Group |
| Routine Phase 1 cardiac rehabilitationRoutine Phase 1 cardiac rehabilitation only. | Other | Experimental Group, Routine Phase 1 cardiac rehabilitation |
Primary outcome
Functional Independence Measure
Time frame: 6 Days
The Functional Independence Measure (FIM) is an instrument that was developed as a measure of disability for a variety of populations and is not specific to any diagnosis. The FIM instrument Includes measures of independence for self-care, including sphincter control, transfers, locomotion, communication, and social cognition. Is an 18-item, seven-level, ordinal scale intended to be sensitive to changes over the course of a comprehensive inpatient medical rehabilitation program. Uses the level of assistance an individual needs to grade functional status from total independence to total assistance). The tool is used to assess a patient's level of disability as well as a change in patient status in response to rehabilitation or medical intervention. FIM 3 levels.
6 Minute Walk Test
Time frame: 6 Days
The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity
Forced expiratory volume (FEV1)
Time frame: 6 Days
Forced expiratory volume (FEV1) calculates the amount of air that a person can force out of their lungs in 1 second. It's measured by spirometry
Forced vital capacity (FVC)
Time frame: 6 Days
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from your lungs after taking the deepest breath possible. It's measured by spirometry
FEV1/FVC ratio
Time frame: 6 Days
The FEV1/FVC ratio is the ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. The normal value for this ratio is above 0.75-85. It's measured by spirometry
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 23 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Muhammad Faizan Hamid, Ms-CPPT principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lower Limb Resistance Band Exercises and Routine Phase 1 cardiac rehabilitation in people with Cardiovascular Diseases, run by Riphah International University at 1 site in Pakistan.
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 6 inclusion and 8 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 23 Jul 2024. 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 Pakistan. 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?
Functional Independence Measure (time frame: 6 Days). The study lists 5 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 23 Jul 2024.