An interventional study of High-Intensity Interval Training and Moderate-Intensity Continuous Training in Physical Inactivity, sponsored by Saif Rasheed Ghanim. Completed at 1 site in Iraq. Open to participants aged 18 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-22.
Sponsored by Saif Rasheed Ghanim · Not applicable, Interventional, and Basic science
This randomized, work-matched training-detraining-rechallenge study evaluated whether repeated high-intensity interval training produces persistent functional and epigenetic adaptations in human monocytes. Eighty healthy physically inactive adults aged 18-30 years were randomly assigned in a 2:2:1 ratio to high-intensity interval training (HIIT), moderate-intensity continuous training (MCT), or a non-training control group. HIIT and MCT completed 6 weeks of supervised cycling training matched for external mechanical work, followed by 4 weeks without prescribed structured training. All groups subsequently completed a standardized 30-minute cycling rechallenge. The primary outcome was the between-group difference in change in ex-vivo LPS-stimulated TNF-alpha release from baseline to the post-detraining assessment. Secondary outcomes included IL-6 release, H3K18 lactylation, monocyte subset distribution, blood lactate exposure, chromatin accessibility, H3K18la CUT\&Tag occupancy, and RNA-seq transcriptional profiling.
Participants completed baseline cardiopulmonary exercise testing to determine peak oxygen uptake (VO2peak) and maximal aerobic power (MAP). Eligible participants were randomized to HIIT, MCT, or Control. The HIIT intervention consisted of 4 × 4-minute cycling intervals at 85% MAP separated by active recovery at 40% MAP, with standardized warm-up and cool-down periods. The MCT intervention consisted of continuous cycling at 55% MAP for a duration selected to match the external mechanical work of the HIIT sessions. Both exercise groups trained three times per week for 6 weeks.
Blood and monocyte assessments were performed at baseline (T0), 72 hours after the final training session (T1), after 4 weeks without prescribed structured training (T2_PRE), and 120 minutes after a standardized 30-minute cycling rechallenge at 60% of baseline MAP (T3_POST).
Classical monocytes were isolated and stimulated ex vivo with ultrapure Escherichia coli O111:B4 lipopolysaccharide (10 ng/mL) for 24 hours. TNF-alpha was the prespecified primary functional outcome, with IL-6 as a key secondary outcome. Epigenetic and molecular analyses included global H3K18 lactylation, ATAC-seq chromatin accessibility profiling, H3K18la CUT\&Tag, and RNA-seq. Blood lactate kinetics and cumulative lactate exposure across the training intervention were also assessed.
The primary comparison was HIIT versus MCT. The Control group served as a supportive non-training reference. Longitudinal outcomes were analyzed using mixed models for repeated measures under the intention-to-treat principle.
1,273 studies on the registry are indexed under Sedentary Behavior; 300 are open to participants now.
This study's enrollment of 80 is above the median of 60 across 1,076 interventional studies indexed under Sedentary Behavior.
Browse Sedentary Behavior studies →Saif Rasheed Ghanim is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Men and women aged 18-30 years. Healthy adults. Physically inactive, defined as participating in less than 150 minutes per week of structured moderate-to-vigorous exercise during the preceding 6 months.
Exclusion Criteria:
Current tobacco use. Current use of relevant immunomodulatory, anti-inflammatory, , or cardiovascular medications.
Acute infection within 4 weeks before baseline assessment. Musculoskeletal to maximal cycling exercise. Pregnancy or lactation.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants completed 6 weeks of supervised cycling high-intensity interval training, three sessions per week. Each session consisted of a 5-minute warm-up at 30% of maximal aerobic power (MAP), four 4-minute intervals at 85% MAP separated by three 3-minute active recovery periods at 40% MAP, followed by a 5-minute cool-down at 30% MAP.
Behavioral: High-Intensity Interval Training
Participants completed 6 weeks of supervised moderate-intensity continuous cycling training, three sessions per week. Each session consisted of a 5-minute warm-up at 30% of maximal aerobic power (MAP), 31 minutes and 16 seconds of continuous cycling at 55% MAP, followed by a 5-minute cool-down at 30% MAP. The protocol was designed to match the external mechanical work performed by the HIIT group.
Behavioral: Moderate-Intensity Continuous Training
Participants received no prescribed structured exercise training during the 6-week intervention period and were instructed to maintain their habitual physical activity and lifestyle. They underwent the same study assessments as the exercise groups, including the 4-week detraining period and the standardized 30-minute cycling rechallenge.
Supervised cycling HIIT performed three sessions per week for 6 weeks. Each session included a 5-minute warm-up at 30% MAP, four 4-minute intervals at 85% MAP separated by three 3-minute active recovery periods at 40% MAP, and a 5-minute cool-down at 30% MAP.
Supervised moderate-intensity continuous cycling performed three sessions per week for 6 weeks. Each session included a 5-minute warm-up at 30% MAP, 31 minutes and 16 seconds of continuous cycling at 55% MAP, and a 5-minute cool-down at 30% MAP. The protocol was designed to match the external mechanical work performed by the HIIT group.
Change in LPS-Stimulated TNF-Alpha Release From Classical Monocytes
TNF-alpha concentration (pg/mL) was measured in culture supernatants after 24-hour ex-vivo stimulation of purified classical CD14++CD16- monocytes with 10 ng/mL ultrapure Escherichia coli O111:B4 lipopolysaccharide. The primary outcome was the change from baseline (T0) to the post-detraining assessment (T2\_PRE), with the primary comparison between the HIIT and MCT groups.
Time frame: Baseline (T0) and 4 weeks after completion of the 6-week training intervention (T2_PRE).
Change in LPS-Stimulated IL-6 Release From Classical Monocytes
IL-6 concentration (pg/mL) was measured in culture supernatants after 24-hour ex-vivo stimulation of purified classical CD14++CD16- monocytes with 10 ng/mL ultrapure Escherichia coli O111:B4 lipopolysaccharide. The outcome was the change from baseline (T0) to the post-detraining assessment (T2\_PRE), with comparison between the HIIT and MCT groups.
Time frame: Baseline (T0) and 4 weeks after completion of the 6-week training intervention (T2_PRE).
Exercise-Rechallenge Change in LPS-Stimulated TNF-Alpha Release From Classical Monocytes
TNF-alpha concentration (pg/mL) was measured after 24-hour ex-vivo stimulation of purified classical CD14++CD16- monocytes with 10 ng/mL ultrapure Escherichia coli O111:B4 lipopolysaccharide. The outcome was the within-participant change from the post-detraining pre-rechallenge assessment (T2\_PRE) to 120 minutes after the standardized exercise rechallenge (T3\_POST), with the principal comparison between the HIIT and MCT groups.
Time frame: Immediately before the standardized exercise rechallenge (T2_PRE) and 120 minutes after the rechallenge (T3_POST).
Exercise-Rechallenge Change in LPS-Stimulated IL-6 Release From Classical Monocytes
IL-6 concentration (pg/mL) was measured after 24-hour ex-vivo stimulation of purified classical CD14++CD16- monocytes with 10 ng/mL ultrapure Escherichia coli O111:B4 lipopolysaccharide. The outcome was the within-participant change from the post-detraining pre-rechallenge assessment (T2\_PRE) to 120 minutes after the standardized exercise rechallenge (T3\_POST), with the principal comparison between the HIIT and MCT groups.
Time frame: Immediately before the standardized exercise rechallenge (T2_PRE) and 120 minutes after the rechallenge (T3_POST).
Change in Monocyte H3K18 Lactylation Across Study Time Points
Histone H3 lysine 18 lactylation (H3K18la) was quantified in purified classical CD14++CD16- monocytes and normalized to total histone H3 abundance. H3K18la was assessed to determine training-induced elevation, persistence after 4 weeks without prescribed structured training, and re-amplification following the standardized exercise rechallenge.
Time frame: Baseline (T0), 72 hours after the final training session (T1), 4 weeks after training cessation before rechallenge (T2_PRE), and 120 minutes after the standardized exercise rechallenge (T3_POST).
Genome-Wide Chromatin Accessibility in Classical Monocytes
Genome-wide chromatin accessibility was assessed by ATAC-seq in purified classical CD14++CD16- monocytes. Differentially accessible regions between the HIIT and MCT groups were identified using a false discovery rate (FDR) \<0.05 and an absolute log2 fold-change \>1.0.
Time frame: Four weeks after completion of the 6-week training intervention, before the standardized exercise rechallenge (T2_PRE).
Genome-Wide H3K18la Occupancy in Classical Monocytes
Genome-wide histone H3 lysine 18 lactylation (H3K18la) occupancy was profiled by CUT\&Tag in purified classical CD14++CD16- monocytes. H3K18la-enriched genomic regions were identified and their overlap with differentially accessible ATAC-seq regions was evaluated between the HIIT and MCT groups.
Time frame: Four weeks after completion of the 6-week training intervention, before the standardized exercise rechallenge (T2_PRE).
Genome-Wide Differential Gene Expression in Classical Monocytes
Genome-wide transcript abundance was assessed by RNA sequencing (RNA-seq) in purified classical CD14++CD16- monocytes. Differential gene expression between the HIIT and MCT groups was evaluated using DESeq2, with differentially expressed genes defined using a false discovery rate (FDR) \<0.05 and an absolute log2 fold-change \>1.0.
Time frame: Four weeks after completion of the 6-week training intervention, before the standardized exercise rechallenge (T2_PRE).
Monocyte Subset Distribution Across Study Time Points
Peripheral blood monocyte subset distribution was quantified by flow cytometry as the percentage of classical (CD14++CD16-), intermediate (CD14++CD16+), and non-classical (CD14+CD16++) monocytes among viable HLA-DR+ monocytes. This outcome was used to evaluate whether training, detraining, or the standardized exercise rechallenge altered circulating monocyte subset composition.
Time frame: Baseline (T0), 72 hours after the final training session (T1), 4 weeks after training cessation before rechallenge (T2_PRE), and 120 minutes after the standardized exercise rechallenge (T3_POST).
Blood Lactate Exposure During the 6-Week Training Intervention
Blood lactate exposure was assessed during the supervised HIIT and MCT training interventions. Measures included acute peak blood lactate concentration, session lactate area under the concentration-time curve (AUC), and cumulative lactate AUC across the 18 training sessions. Lactate exposure was compared between the work-matched HIIT and MCT groups.
Time frame: Across the 18 supervised training sessions during the 6-week intervention.
Plan to share: Yes — De-identified individual participant data underlying the results reported in the primary publication will be available for sharing. Shared data may include participant characteristics, intervention allocation, longitudinal cytokine outcomes, H3K18 lactylation measures, monocyte phenotyping, and processed omics-derived variables, after removal of information that could permit participant identification.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
Time frame: Data and supporting information will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
Access criteria: Access will be considered for qualified researchers who submit a scientifically sound research proposal. Requests will be reviewed by the principal investigator. Approved researchers will receive access to de-identified data only for the purposes specified in the approved proposal and subject to applicable ethical, confidentiality, and data-use requirements.
No publications or documents are linked to this record.
Ran from Jan 2025 to primary completion in Jun 2025, 5 months.
Of 733 non-industry interventional studies with no phase under Sedentary Behavior, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 31. This study's 5 months is below that.
Counting every sponsor, half of 741 studies reached it within 14 months; a quarter within 6 and three quarters within 31.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Saif Rasheed Ghanim