Getting a grip on hypertension in Uganda: giving repetitive isometric exercise for blood pressure control
| ISRCTN | ISRCTN46005092 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46005092 |
- Submission date
- 29/10/2024
- Registration date
- 31/10/2024
- Last edited
- 30/10/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Circulatory System
Plain English Summary
Background and study aims
Even though medication treatments for high blood pressure (hypertension) have known effective results, other complementary interventions could help control blood pressure in hypertensive patients. Isometric handgrip training (IHT), a form of resistance training, is a promising simple and low-cost intervention. IHT consists of doing multiple static forearm contractions on a stress ball, separated by short periods of rest. Most research on IHT to date has had few, mostly White participants in high-income settings. However, understanding the efficacy of IHT in a Ugandan context will inform treatment strategies for hypertensive patients in Uganda. This study aims to see if IHT has an impact on the blood pressure levels of hypertensive patients after 12 weeks of training. The study will determine the effects of IHT compared to usual care in a population of hypertensive patients at the Allan Stone Community Health Clinic (Kyabirwa, Uganda)
Who can participate?
Patients aged over 18 years old with a diagnosis of stage 1 hypertension, as defined per the clinic standards
What does the study involve?
Consenting participants will be randomly separated into two groups: a “control” group that will receive the standard care for hypertension given at the Allan Stone Community Health Clinic, and an “intervention” group that will perform IHT sessions 3 times a week for 12 weeks, in addition to receiving standard care.
IHT sessions will consist of 4 two-minute forearm contractions performed on a stress ball, using alternate hands with 1 minute rest periods between contractions. Weekly training sessions will be held at the Allan Stone Community Health Clinic for a small group of participants and will be supervised by a member of the research team. If unable to attend the group sessions, participants will have the option to participate in an individual training session with research staff at another time during the week.
Data will be collected at 4 different time points: 1) at the baseline visit; 2) at the 1st monthly clinic visit (1 month); 3) at the 2nd monthly clinic visit (2 months); and 4) at the endline visit (3 months).
Blood pressure will be measured for all participants during the clinic visits at baseline, 1, 2, and 3 months.
Both groups will answer a questionnaire about sociodemographics, lifestyle, health information and hypertension knowledge during the baseline clinic visit. A shorter version of the questionnaire will be completed during the clinic visits at 1, 2, and 3 months.
Participants in the “intervention” group will be asked to answer additional questions about their experience with IHT during the endline clinic visit at 3 months. They could also be invited to participate in an interview to further discuss their experience with IHT and home-based IHT.
What are the possible benefits and risks of participating?
If participants are prescribed hypertensive medication by the clinic during their participation, the cost of the medication and associated care will be covered by the study. The results obtained from this study will contribute to the advancement of scientific knowledge in this field of research. Time spent participating in this research project and transit are the main inconveniences associated with this study. Participants may experience numbness and/or tingling in the arm while their blood pressure is being measured. IHT is a safe intervention for adults with hypertension, and the risk of experiencing tendonitis in the arm from the handgrip exercise is low if the exercise is performed correctly. To ensure proper exercise technique, a member of the research team will supervise the IHT training sessions. The research team will also closely monitor participants’ blood pressure and any safety events.
Where is the study run from?
The study, managed by the University of Montreal, will take place at the Allan Stone Community Health Clinic (Kyabirwa, Uganda).
When is the study starting and how long is it expected to run for?
March 2023 to July 2026
Who is funding the study?
The Canadian Institutes of Health Research (CIHR)
Who is the main contact?
Dr Kate Zinszer, kate.zinszer@umontreal.ca
Contact information
Public, Scientific, Principal Investigator
École de santé publique de l'Université de Montréal
7101 avenue du Parc, Bureau 3153
Montreal
H3N 1X9
Canada
 ORCID ID |
0000-0003-1388-1145 |
|---|---|
| Phone | +1 514 343-6111 #44034 |
| kate.zinszer@umontreal.ca |
Study information
| Study design | Single-centre two-arm parallel randomized controlled superiority trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | GP practice, Medical and other records |
| Study type | Efficacy |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Estimating the efficacy of isometric handgrip training on lowering blood pressure in patients with hypertension in Eastern Uganda compared to usual treatment |
| Study acronym | GRIP in Uganda |
| Study hypothesis | The hypothesis that 12 weeks of isometric handgrip training (IHT) will produce statistically significant reductions in resting systolic blood pressure (BP) when compared to standard care for hypertension will be tested. |
| Ethics approval(s) |
1. Approved 19/06/2024, Clinical Research Ethics Committee at the University of Montreal (C.P. 6128, succ. Centre-ville, Montreal, H3C 3J7, Canada; +1 514-343-6111 #1896; timothee.gallen@umontreal.ca), ref: 2024-5649 2. Approved 27/07/2024, Mbarara University of Science and Technology Research Ethics Committee (P.O. Box 1410, Mbarara, -, Uganda; +256 485433795; sec.rec@must.ac.ug), ref: MUST-2024-1547 3. Approved 22/08/2024, Uganda National Council for Science and Technology (Plot 6, Kimera Road, Ntinda, P.O. Box 6884, Kampala, -, Uganda; +256 414705500; info@unsct.go.ug), ref: HS4712ES |
| Condition | Hypertension stage 1 (BP >140-159/90-99 mmHg) |
| Intervention | Participants will be randomized with equal allocation to intervention and control groups. A computer-generated randomization will be used for random permuted blocks of 4, 6, or 8 to allocate participants to either of the arms. The control group will receive standard care for hypertension for a duration of 12 weeks, as per clinic standard practice. Standard care at the clinic is based on Ugandan Ministry of Health clinical guidelines. Health behaviour and lifestyle guidance provided by clinic staff are the first line of treatment for patients with BP >140 mmHg/90 mmHg (stage 1 HTN) but below 160 mmHg/100 mmHg (stage 2 HTN). If there is no improvement after three months of follow-up with stage 1, drug therapy is initiated in combination with continued lifestyle and health behaviour guidance. If there is no improvement after one month of drug therapy initiation, it is then classified as stage 2 HTN. The recommended drug therapies are calcium channel blockers as first line treatment. The intervention group will receive standard care for hypertension and will perform IHT sessions three time a week for a duration of 12 weeks. In-person IHT sessions will be held at the Allan Stone Community Health Clinic. Each training session will consist of 4 two-minute isometric handgrip contractions performed at a rating of perceived exertion of a 6 on a 10-point scale (equivalent to ~30% maximal voluntary contraction), using alternate hands with 1 minute rest periods between contractions. Participants will attend 3 supervised group sessions per week. If participants are not able to attend the group sessions, participants will have the option to participate to an individual training session with research staff at another time during the week. |
| Intervention type | Behavioural |
| Primary outcome measure | Mean resting systolic BP will be measured using the validated automated Omron HEM-907XL device at baseline, 1, 2 and 3 months |
| Secondary outcome measures | 1. Mean resting diastolic BP measured using the validated automated Omron HEM-907XL device at baseline, 1, 2 and 3 months 2. The need for HTN medication measured using clinical guidelines and BP levels at 3 months 3. Safety outcomes (hospital admission for hypertensive crisis, severe (>180/110 mmHg), new myocardial infarction, transient ischemic attack, new embolic event) measured by a questionnaire and medical records throughout the 12 weeks of intervention 4. Intervention and control group adherence measured by IHT sessions attendance and monthly clinic visits throughout the 12 weeks of intervention 5. HTN medication adherence measured through self-report and pill counting at baseline, 1, 2 and 3 months 6. Sociodemographic and general health information measured by a questionnaire at baseline, 1, 2 and 3 months 7. Economic benefits of the intervention measured by tracking the cost of the intervention, guided in-person IHT sessions, healthcare utilization for HTN-related services, hypertensive medications, and transport to the clinic throughout the 12 weeks of intervention 8. Knowledge, attitudes, and practices (KAP) about HTN measured by a questionnaire at baseline and 3 months 9. Experience with IHT measured by a questionnaire at 3 months 10. Acceptability of IHT and home-based IHT measured by a semi-structured interview at 3 months |
| Overall study start date | 01/03/2023 |
| Overall study end date | 31/07/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | The total target number of participants is 250, with equal allocation of 125 participants to the intervention group (IHT and standard care) and the control group (standard care only). |
| Participant inclusion criteria | 1. Diagnosis of stage 1 HTN (BP >140-159/90-99 mmHg), which is based on the clinic and MOH definitions 2. Not currently taking HTN medication 3. Not having been on HTN medication in the past 3 months 4. Aged > 18 years and older |
| Participant exclusion criteria | 1. Diagnosis of stage 1 HTN and currently taking HTN medication 2. Diagnosis of stage 2 HTN 3. Diabetes 4. History of recent myocardial infarction (in the past year) 5. Congestive heart failure 6. Complete heart block 7. Unstable angina 8. Glomerular Filtration rate of 90 or lower 9. Any pregnancy-associated HTN 10. Any limitation (e.g., limited hand mobility) preventing proper performance of IHT exercise 11. Any other condition that alters autonomic nervous system function |
| Recruitment start date | 26/08/2024 |
| Recruitment end date | 02/02/2026 |
Locations
Countries of recruitment
- Uganda
Study participating centre
-
Uganda
Sponsor information
University/education
Centre De Recherche en Santé Publique, Pavillon 7101 avenue du Parc, 3e étage
Montréal
H3N 1X9
Canada
| Phone | +1 514 343-6185 |
|---|---|
| cresp.ccsmtl@ssss.gouv.qc.ca | |
| Website | https://www.cresp.ca/fr |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
- Location
- Canada
Results and Publications
| Intention to publish date | 31/07/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | The results of the project will be disseminated as group data. The information obtained by the research team will be analyzed and the results of this analysis will be available in peer-reviewed scientific journals, presentations at scientific conferences or seminars, and institutional reports. A summary report will be shared with participants. Individual results, such as blood pressure measures, will be provided to participants during the clinic visits and/or at the end of the study. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study will be available upon request from the principal investigator (Dr. Kate Zinszer, kate.zinszer@umontreal.ca), once the data have been published. Data will be anonymized and made available if consent from participants is obtained. |
Editorial Notes
30/10/2024: Study's existence confirmed by the Clinical Research Ethics Committee at the University of Montreal.
