Chronotype-aligned exercise timing in middle-aged adults at cardiometabolic risk

ISRCTN	ISRCTN14276441
DOI	https://doi.org/10.1186/ISRCTN14276441
Sponsor	University of Lahore
Funder	Investigator initiated and funded

Submission date: 03/02/2026
Registration date: 05/02/2026
Last edited: 05/02/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nutritional, Metabolic, Endocrine

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Plain English summary of protocol not provided at time of registration

Contact information

Dr Arsalan Tariq
Principal investigator, Public

1-Km Defence Road, near Bhuptian Chowk
Lahore
54000
Pakistan

Phone	+923443186795
Email	at81931@gmail.com

Dr Muhammad Ammar
Scientific

Defense road
Lahore
54001
Pakistan

Phone	+923138092081
Email	ammarkhanazxc36@gmail.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Supportive care
Participant information sheet	48967_PIS.pdf
Scientific title	Effects of chronotype-aligned versus chronotype-misaligned aerobic exercise on cardiovascular, metabolic, and sleep outcomes: a randomized controlled trial
Study objectives	To investigate whether aligning exercise timing with chronotype enhances cardiometabolic and sleep-related benefits in sedentary adults with cardiovascular risk factors.
Ethics approval(s)	Approved 02/01/2025, Research ethics committee, The university of Lahore (1-Km Defence Road, near Bhuptian Chowk, Lahore, Lahore, 54000, Pakistan; +92 42 111-865-865; info@uol.edu.pk), ref: REC-UOL-002-01-2025
Health condition(s) or problem(s) studied	Cardiovascular risk factors in sedentary middle-aged adults (40–60 years), including prehypertension, stage 1 hypertension, overweight/obesity, impaired fasting glucose, and family history of premature cardiovascular disease.
Intervention	Participants were randomized using computer-generated permuted blocks of size 4 and 6, stratified by chronotype (morning or evening) and cardiovascular risk level (low, moderate). Block sizes were randomly varied to maintain allocation concealment. Allocation was performed independently using sealed envelopes prepared by staff not involved in outcome assessment. Chronotype-Aligned Exercise (CAE) Group: Participants performed moderate-intensity aerobic exercise at a time aligned with their individual chronotype, determined using the Morningness–Eveningness Questionnaire (MEQ). Morning-type participants exercised in the morning (08:00–11:00) Evening-type participants exercised in the evening (18:00–21:00) Chronotype-Misaligned Exercise (CME) Group: Participants performed the same aerobic exercise protocol at a time not aligned with their chronotype. Morning-type participants exercised in the evening (18:00–21:00) Evening-type participants exercised in the morning (08:00–11:00) Exercise Protocol (Both Groups) Mode: Brisk walking or treadmill walking Intensity: Moderate (60–70% of age-predicted maximum heart rate) Session duration: 40 minutes (5-min warm-up, 30-min aerobic phase, 5-min cool-down) Frequency: 5 sessions per week Duration: 12 weeks Setting: Supervised hospital gym sessions Monitoring: Heart rate monitored using Polar® H10 sensors
Intervention type	Behavioural
Primary outcome measure(s)	Systolic and diastolic blood pressure and heart rate variability (RMSSD) were measured using an automated sphygmomanometer, and a 5-minute resting ECG (RMSSD), respectively, at baseline and after 12 weeks of intervention
Key secondary outcome measure(s)	Estimated VO₂ peak and exercise performance (total time and Bruce protocol stage) measured using the Bruce submaximal treadmill protocol with heart-rate monitoring at baseline (Week 0) and after completion of the intervention at Week 12 Metabolic markers: Lipid profile (LDL cholesterol), glycemic markers (fasting glucose and HbA1c) measured using standard procedures with fasting blood samples at baseline (Week 0) and after completion of the intervention at Week 12 Sleep quality measured using the Pittsburgh Sleep Quality Index (PSQI) at baseline (Week 0) and after completion of the intervention at Week 12 Exercise adherence measured using supervised attendance logs and the Exercise Adherence Rating Scale (EARS) at baseline (Week 0) and after completion of the intervention at Week 12
Completion date	16/06/2025

Eligibility

Participant type(s)
Age group	Adult
Lower age limit	40 Years
Upper age limit	60 Years
Sex	All
Target sample size at registration	150
Total final enrolment	134
Key inclusion criteria	1. Age 40–60 years 2. Sedentary lifestyle (no structured physical activity ≥1 session/week in the past 3 months) 3. At least one cardiovascular risk factor: 4. Prehypertension or stage 1 hypertension 5. Overweight/obesity (BMI ≥ 25 kg/m²) 6. Impaired fasting glucose 7. Family history of premature cardiovascular disease 8. Regular sleep schedules
Key exclusion criteria	1. Clinically diagnosed cardiovascular or metabolic diseases (e.g., coronary artery disease, diabetes) 2. Night shift workers or irregular sleep schedules 3. Diagnosed sleep disorders (e.g., insomnia, obstructive sleep apnea) 4. Medications affecting cardiovascular or circadian regulation (unless stable ≥6 months) 5. Intermediate chronotype (Morningness-Eveningness Questionnaire score 42–58)
Date of first enrolment	06/01/2025
Date of final enrolment	14/03/2025

Locations

Countries of recruitment

Pakistan

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
IPD sharing plan

Study outputs

Output type	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	05/02/2026	No	Yes
Protocol file	05/02/2026	No	No
Statistical Analysis Plan	05/02/2026	No	No

Additional files

48967_Protocol.pdf: Protocol file
48967_SAP.pdf: Statistical Analysis Plan
48967_PIS.pdf: Participant information sheet

Editorial Notes

04/02/2026: Study’s existence confirmed by the Research Ethics Committee (REC), Faculty of Allied Health Sciences, The University of Lahore, Pakistan.