| Changes to trial information |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Trial Information |
Public title |
31/07/2026 |
PACTR Admin |
EFFECTIVENESS OF A STRUCTURED CHAIR-BASED EXERCISE INTERVENTION ON BLOOD PRESSURE CONTROL AMONG DESK-BASED WORKERS WITH HYPERTENSION IN SOUTHERN NIGERIA: A RANDOMIZED CONTROLLED TRIAL |
Effectiveness of a structured chair-based exercise intervention on blood pressure control among desk-based workers with hypertension in southern Nigeria: a randomized controlled trial |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
30/05/2026 |
Group removed from the intervention name as it is not part of the intervention name |
Experimental Group, Chair based exercise group, Each exercise will be performed for one minute, giving a total exercise duration of approximately five minutes per session. Participants will be instructed to perform the exercise routine every 60 minutes during working hours over an average 8-hour workday, amounting to approximately 40 minutes of daily physical activity., The study intervention will last for 3 months while participants will be followed up for six months, with assessments conducted at baseline, 3 months, and 6 months., Participants in the intervention arm will receive standard hypertension care in addition to a structured chair-based exercise programme designed for workplace implementation.
The exercise programme will consist of five chair-based exercises:
• Seated marching
• Knee extensions
• Seated calf raises
• Seated torso rotations
• Seated jumping jacks
Each exercise will be performed for one minute, giving a total exercise duration of approximately five minutes per session. Participants will be instructed to perform the exercise routine every 60 minutes during working hours over an average 8-hour workday, amounting to approximately 40 minutes of daily physical activity.
The intervention will be delivered through:
1. An initial supervised demonstration session,
2. Printed instructional materials,
3. Weekly reminder messages via WhatsApp or SMS,
4. Monthly reinforcement sessions during clinic visits.
Exercise intensity will be maintained at low-to-moderate intensity corresponding to 9–13 on the Borg Rating of Perceived Exertion scale.
Adherence will be monitored using self-reported activity diaries and periodic telephone follow-up. Adherence will be defined as completion of at least 80% of prescribed exercise sessions throughout the intervention period.
, 109, |
Experimental Group, Chair based exercise, Each exercise will be performed for one minute, giving a total exercise duration of approximately five minutes per session. Participants will be instructed to perform the exercise routine every 60 minutes during working hours over an average 8-hour workday, amounting to approximately 40 minutes of daily physical activity., The study intervention will last for 3 months while participants will be followed up for six months, with assessments conducted at baseline, 3 months, and 6 months., Participants in the intervention arm will receive standard hypertension care in addition to a structured chair-based exercise programme designed for workplace implementation.
The exercise programme will consist of five chair-based exercises:
• Seated marching
• Knee extensions
• Seated calf raises
• Seated torso rotations
• Seated jumping jacks
Each exercise will be performed for one minute, giving a total exercise duration of approximately five minutes per session. Participants will be instructed to perform the exercise routine every 60 minutes during working hours over an average 8-hour workday, amounting to approximately 40 minutes of daily physical activity.
The intervention will be delivered through:
1. An initial supervised demonstration session,
2. Printed instructional materials,
3. Weekly reminder messages via WhatsApp or SMS,
4. Monthly reinforcement sessions during clinic visits.
Exercise intensity will be maintained at low-to-moderate intensity corresponding to 9–13 on the Borg Rating of Perceived Exertion scale.
Adherence will be monitored using self-reported activity diaries and periodic telephone follow-up. Adherence will be defined as completion of at least 80% of prescribed exercise sessions throughout the intervention period.
, 109, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Intervention |
Intervention List |
30/05/2026 |
group is not part of the intervention hence removed |
Control Group, Standard care group, Not applicable, 6 months, Participants in the control group will receive standard hypertension care only, including pharmacologic treatment, lifestyle counselling, dietary advice, and routine clinic follow-up in accordance with institutional hypertension management protocols., 109, Active-Treatment of Control Group |
Control Group, Standard care, Not applicable, 6 months, Participants in the control group will receive standard hypertension care only, including pharmacologic treatment, lifestyle counselling, dietary advice, and routine clinic follow-up in accordance with institutional hypertension management protocols., 109, Active-Treatment of Control Group |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
30/05/2026 |
time point clarified to include post intervention |
Primary Outcome, • Mean change in systolic blood pressure from baseline to 6 months. , 3 months and 6 months |
Primary Outcome, • Mean change in systolic blood pressure from baseline to 6 months. , 3 months and 6 months post intervention |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Outcome |
OutCome List |
30/05/2026 |
post intervention included on the time point to clarify it |
Secondary Outcome, • Mean change in diastolic blood pressure,
• Proportion of participants achieving blood pressure control,
• Changes in BMI,
• Changes in waist circumference and waist-to-hip ratio,
• Adherence to the chair-based exercise programme., 3 months and 6 months |
Secondary Outcome, • Mean change in diastolic blood pressure,
• Proportion of participants achieving blood pressure control,
• Changes in BMI,
• Changes in waist circumference and waist-to-hip ratio,
• Adherence to the chair-based exercise programme., 3 months and 6 months post intervention |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Ethics |
Ethics List |
05/07/2026 |
Ethical approval received |
FALSE, Edo State University Teaching Hospital Research and Ethics Committee, Old Igarra Road, Auchi, Edo State., Auchi, 320001, Nigeria, 21 May 2026, , +2348036281897, edsuth@edouniversity.edu.ng, |
TRUE, Edo State University Teaching Hospital Research and Ethics Committee, Old Igarra Road, Auchi, Edo State., Auchi, 320001, Nigeria, 21 May 2026, 05 Jun 2026, +2348036281897, edsuth@edouniversity.edu.ng, 41390_38626_4737.pdf |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Funding Source |
FundingSources List |
30/05/2026 |
Actual name of principal investigator written as source of funding |
Self Funded, Old Igarra Road, Auchi, Edo State., Auchi, 320001, Nigeria, Self Funded, |
Tijani Idris Ahmad Oseni, Old Igarra Road, Auchi, Edo State., Auchi, 320001, Nigeria, Self Funded, |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD description |
30/05/2026 |
IPD description reviewed to include raw data after de-identification |
Individual Participant Data (IPD) will be stored in password protected files accessible only to the researcher |
Individual Participant Data (IPD) including raw data that has been de-identified and additional documents used in the study will be shared after de-identification. |
|
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
| Reporting |
IPD-Sharing time frame |
30/05/2026 |
The time from from start to end specified |
IPD will be shared to participants on request and will be available for upto two years after the completion of the study |
IPD documents will be available from the time of completion of the study to upto two years after the completion of the study |