UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045380 |
|---|---|
| Receipt number | R000051820 |
| Scientific Title | Impact of Cardiac Rehabilitation on Cardiorespiratory parameters: Towards establishment of CR intervention at Queen Elizabeth Central Hospital |
| Date of disclosure of the study information | 2021/09/05 |
| Last modified on | 2023/03/08 17:24:48 |
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Basic information
Public title
Impact of Cardiac Rehabilitation on Cardiorespiratory parameters: Towards establishment of CR intervention at Queen Elizabeth Central Hospital
Acronym
Impact of Cardiac Rehabilitation on Cardiorespiratory parameters: Towards establishment of CR intervention at Queen Elizabeth Central Hospital
Scientific Title
Impact of Cardiac Rehabilitation on Cardiorespiratory parameters: Towards establishment of CR intervention at Queen Elizabeth Central Hospital
Scientific Title:Acronym
Impact of Cardiac Rehabilitation on Cardiorespiratory parameters: Towards establishment of CR intervention at Queen Elizabeth Central Hospital
Region
| Africa |
Condition
Condition
Congestive Heart Failure
Classification by specialty
| Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The overall aim of this study is to carry out a pilot study to determine the impact of cardiovascular rehabilitation (CR) among patients with a diagnosis of Congestive Heart Failure (CHF). The specific objectives are as follows;
1. To describe the improvements in cardiovascular function among patients with CHF following administration of CR
2. To describe the frequency of hospitalization among patients diagnosed with CHF
3. To describe the challenges that may be associated with establishment of a CR program at QECH
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cardiorespiratory parameters ie. blood pressure, pulse rate, respiratory rate and oxygen saturation, including exercise tolerance capacity for patients are measured at baseline and after 8, 12, 16 and 24 weeks of receiving CR; the measurements are recorded in a data collection form. All health care workers are provided with questionnaires to input challenges encountered during care delivery, and suggest possible solutions. It is hypothesized that;
1. Patients with CHF would have improved cardiac function
2. Patients with CHF would have increased exercise tolerance capacity
3. Cardiac rehabilitation will be established in a more sustainable way at QECH
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Behavior,custom | Maneuver |
| Other |
Interventions/Control_1
Cardiac rehabilitation intervention is to be delivered; constituting prescribed exercise therapy, education and counseling therapies, and monitoring of their well-being and adherence to the secondary prevention medications they are put on by their cardiologists. This intervention will only be given to the treatment arm, and is delivered twice a week at the hospital with one day at home under the supervision of a trained guardian, for a period of 12 weeks. Patients' guardians are to be trained to facilitate and supervise the individualized home exercise program at the beginning of therapy sessions in this study.
The exercise therapy is to be prescribed using 40-70% Heart Rate Reserve for cardiovascular training in relation to patients' Rating of Perceived Exertion (RPE), and exercise monitoring will be done using RPE. Strength training will be prescribed using 30-70% of 1 Repetition Maximum (1RM), 2-4 sets and 10-15 repetitions. Patients in treatment arm will exercise for 55 minutes on each day (15 minutes warm up, 30 minutes conditioning and 10 minutes cool down) using a circuit training. aerobic exercises using treadmill, static bike, stepping box and light ball throwing will be employed. Strength training will employ use of sand bags, therabands and weight bearing exercises on a stepping box.
The education and counseling therapy sessions will be for 15 minutes on each day at the hospital.
Interventions/Control_2
The control arm will only receive short education and counseling therapies at baseline, and after 8, 12, 16 and 24 weeks when they come to the hospital for subsequent assessments and data collection for comparisons.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged 18 years and above with a diagnosis of CHF at discharge from hospital, confirmed with an echocardiogram, and attending chest clinic at the QECH
2. On optimized secondary prevention medications
3. Being residents of Blantyre City and its immediate surrounding areas
4. Willing to provide written informed consent and willing to return for follow up
5. Being able to participate in physical activity for cardiac rehabilitation
Key exclusion criteria
1. Failure to provide informed consent
2. Not willing to return for follow up visits
3. Physical impairment that would affect participation in physical activity
4. Patients classified as high risk for cardiac events during exertion
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Alice |
| Middle name | Dwight |
| Last name | Namanja |
Organization
Kamuzu University of Health Sciences
Division name
Physiotherapy Department
Zip code
0000
Address
Kamuzu University of Health Sciences, Mahatma Ghandi Road, Private Bag 360, Blantyre 3. Malawi
TEL
+265997759408
anamanja@medcol.mw
Public contact
Name of contact person
| 1st name | Alice |
| Middle name | Dwight |
| Last name | Namanja |
Organization
Kamuzu University of Health Sciences
Division name
Physiotherapy Department
Zip code
0000
Address
Kamuzu University of Health Sciences, Mahatma Ghandi Road, Private Bag 360, Blantyre 3. Malawi
TEL
+265997759408
Homepage URL
anamanja@medcol.mw
Sponsor or person
Institute
Kamuzu University of Health Sciences
Institute
Department
Personal name
Funding Source
Organization
The Malawi NCD-BRITE Consortium Grant
The Malawi NCD-BRITE Consortium Grant
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Malawi
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The College of Medicine Research and Ethics Committee (COMREC)
Address
P/Bag 360, Blantyre 3. Malawi
Tel
+2651810911
comrec@medcol.mw
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
The Kamuzu University of Health Sciences (Blantyre)
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 09 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 24 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 13 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 16 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 05 | Day |
Last modified on
| 2023 | Year | 03 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051820
