Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202509582330608 Date of Registration: 11/09/2025
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Impact of Exercise on Selected Inflammatory and Cardiac Stress Biomarkers in Type 2 Diabetes and Its Implication for Pulmonary and Cardiac Autonomic Regulation
Official scientific title Impact of Exercise on Selected Inflammatory and Cardiac Stress Biomarkers in Type 2 Diabetes and Its Implication for Pulmonary and Cardiac Autonomic Regulation
Brief summary describing the background and objectives of the trial Background : Research suggests that optimal outcomes in preventing autonomic dysfunction in individuals with type 2 diabetes mellitus (T2DM) can be achieved through a multimodal approach, including both behavioral and pharmacological interventions. Understanding the modulation of these biomarkers of inflammation following exercise could provide insights into the mechanisms by which physical activity enhances autonomic regulation in T2DM patients. Objective: This protocol describes study a randomized controlled trial designed to determine the influence of a structured exercise program on the biomarkers of inflammation, and their role in cardiac and pulmonary autonomic regulation in patients with T2DM
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Nutritional, Metabolic, Endocrine
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2025
Actual trial start date 01/09/2025
Anticipated date of last follow up 01/08/2025
Actual Last follow-up date 31/01/2026
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification Sealed opaque envelopes Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Aerobic exercise 3 times a week, for 12 weeks 30mins to 45mins per day a) Participants will engage in walking on a treadmill or cycling on a stationary bike at 60-75% of their maximal heart rate. Individual physical exercise readiness, risk assessment, and safety will be assessed using the physical activity readiness questionnaire. The maximum heart rate will be assessed using predicted formula of 220 -age allowing for tailored intensity settings. Heart rate monitors will be utilized during sessions to ensure participants maintain the appropriate intensity range. This intensity range is consistent with the American College of Sports Medicine (ACSM) recommendations for individuals with Type 2 Diabetes Mellitus (T2DM), promoting cardiovascular improvements and enhancing overall endurance. b) Sessions will begin with a 5-10-minute warm-up period to prepare participants for aerobic activity, followed by 30-45 minutes of sustained aerobic exercise. The session will conclude with a cool-down period lasting 5-10 minutes to safely lower heart rates, promote recovery, reduce the risk of injury and prevent post-exercise hypotension. 25
Experimental Group Resistance 3 time a week for 12 weeks 30mins to 45 mins a) Strength training exercises will target major muscle groups, including the legs, chest, back, arms, and core through activities like leg presses, bench presses, squats, and seated rows, using resistance bands or weight machines tailored to participants' fitness levels. b) Each session will include 2-3 sets of 8-12 repetitions for each exercise, promoting muscle hypertrophy and improving insulin sensitivity. Resistance levels will be personalized and adjusted every three weeks based on participant feedback and performance metrics, ensuring progressive overload. Ten repitition maximum will be used to determine the weight each participants will carry. 25
Experimental Group combined exercise 3 times a week for 12 weeks 30mins to 40mins Walking on treadmill or cycling on a stationary bike at 60-75% of the maximal heart rate and strength training exercises targeting major muscle groups for 12 weeks (leg press or bench press or weight lighting) 25
Control Group standard diabetes care without an exercise regimen. 12 weeks Participants in the control group will receive standard diabetes care without an exercise regimen. They will be encouraged to maintain their usual activities but will not receive specific exercise guidance. They will be followed up with phone call to ensure adherence 25 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
o Adults aged 18 years and above diagnosed with T2DM for at least 1 years. o HbA1c levels >6% o Patients not currently engaged in regular structured physical activity. o Ability to provide informed consent. o Patients on anti-inflammatory medications. o Smokers and individuals with substance use disorders. o Pregnant or breastfeeding women. Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 70 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 14/03/2025 Health and research ethics comittee
Ethics Committee Address
Street address City Postal code Country
Ituku Ozalla Enugu 400001 Nigeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome o NT-proBNP: Indicator of cardiac stress and heart failure risk. o C-reactive protein (CRP): Marker of systemic inflammation. o Interleukin-6 (IL-6): Cytokine involved in inflammation. o Tumor Necrosis Factor-alpha (TNF-α): Pro-inflammatory cytokine. 1st week before intervention commences and 12th week whe intervention has ended
Secondary Outcome Heart Rate Variability (HRV) and lung function 1st week before intervention starts and 12th week when intervention has ended
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
University of Nigeria Teaching Hospital Enugu and Enugu State Teaching Hospital Ituku Ozalla and G.R.A Enugu 400001 Nigeria
FUNDING SOURCES
Name of source Street address City Postal code Country
Ezinne Olive Nwosu Physiotherapy Department UNTH Ituku Ozalla Enugu Enugu 400001 Nigeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Nwosu Ezinne Physiotherapy Department UNTH Enugu 40001 Nigeria Individual
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Nwosu Ezinne olivexy@yahoo.com +2348033942244 Samuel
City Postal code Country Position/Affiliation
Enugu 400271 Nigeria Deputy Director
Role Name Email Phone Street address
Public Enquiries Ekundayo Fatai fataidayo.fd@gmail.com +2349031747608 Meniru
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Senior Physiotherapist
Role Name Email Phone Street address
Scientific Enquiries Ukwuoma Maryjane kenechukwu@gmail.com +2348145789798 Thinkers corner
City Postal code Country Position/Affiliation
Enugu 400001 Nigeria Principal Physiotherapist
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All IPD that underlies result Informed Consent Form,Study Protocol Starting 6 months post-publication Data will be shared by the corresponding author upon reasonable request via email.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Actual trial start date 06/09/2025 We had logistic problem that delayed take off 01 Sep 2025
Section Name Field Name Date Reason Old Value Updated Value
Trial Information Completion date 06/09/2025 To give room for every patient to exercise for up to 3months 31 Jan 2026
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 11/09/2025 PACTR Admin Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s) Adolescent: 13 Year-18 Year, Adult: 19 Year-44 Year, Middle Aged: 45 Year(s)-64 Year(s), Aged: 65+ Year(s)