Clinical trial NCT07019285: Interval Training and Plasma Volume Variation
Official title: Comparative Effects of High- vs. Moderate Intensity Interval Walking Training on Plasma Volume Variations, Hematological and Muscle-Damage Markers in Overweight/Obese Postmenopausal Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematologic Tests
Keywords: Hematocrit
Plasma volume variation
Interval walking training
Lactate dehydrogenase
Obesity
Lead sponsor: High Institute of Sports and Physical Education of Kef
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 32
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this clinical trial is to to compare the effects of high (HIIWT) versus moderate-intensity interval walking training (MIIWT) on body composition, plasma volume variations (PVV), hematological parameters, muscle damage and aerobic capacity in overweight/obese postmenopausal women. The main question it aims to answer is:Does HIIWT and MIIWT improve kidney function markers in this population? Researchers will compare HIIWT to MIIWT and to non-training intervention(designed to control group) to see if the training program at different intensities work to improve kidney function markers.

Participants in HIIWT group will: perform a 8-week HIIWT program, three sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 90-110% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in MIIWT group will: perform a 8-week MIIWT program, three sessions per week (5 repetitions of 6-min-walking-test (6MWT) at 60-80% of 6MWTdistance measured at baseline, interspersed by 6-min of active recovery between repetitions). Participants in control group will : not perform any physical training and maintain their usual daily activities.

Detailed description: In obese postmenopausal women, hematological disturbances, reduced plasma volume, and elevated muscle damage biomarkers are associated with impaired oxygen delivery, reduced aerobic capacity, and increased risks of cardiovascular disease, sarcopenia, and functional decline. While responses to exercise are well documented in young healthy individuals, evidence in this high-risk population remains scarce. The purpose is to compare the effects of high (HIIWT) versus moderate-intensity interval walking training (MIIWT) on body composition, plasma volume variations (PVV), hematological parameters, muscle damage and aerobic capacity in overweight/obese postmenopausal women.Thirty-two overweight/obese postmenopausal women were randomly assigned to HIIWT (n = 11), MIIWT (n = 11), or control (CON, n = 10) groups. HIIWT and MIIWT groups performed intermittent walking at 90-110% and 60-80% of the 6-min-walking-test distance, respectively, 3 times/week for 8 weeks (60 min/session). Body composition, hematological and muscle damage markers, and 6 min walk test (6MWT) were assessed pre- and post-intervention. PVV was calculated after eight weeks under third conditions (HIIWT, MIIWT and CON).

Eligibility criteria: Inclusion Criteria:

* Age range of 45-59 years.
* Postmenopausal women (cessation of menses for at least 12 consecutive months).
* Body mass index (BMI) ≥ 25 kg/m2.
* Body weight remained constant (±2 kg) during the past 3 months.
* Stable eating habits and physical activity for at least 3 months.
* Sedentary lifestyle (exercise less than 1h/week).

Exclusion Criteria:

* Medical contraindications to physical activity, diagnosed metabolic, hormonal, orthopedic, or cardiovascular conditions.
* Current use of hormone replacement therapy or any prescribed medication.

Primary outcomes:
measure: Erythrocytes
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Hemoglobin
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Hematocrit
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Mean corpuscular volume
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Mean corpuscular hemoglobin content
timeFrame: At baseline and at week 9(after the eight weeks of the training intervention)
measure: Mean hemoglobin concentration
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention)
measure: Creatine kinase
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Lactate dehydrogenase
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Plasma volume variations
timeFrame: Plasma volume variations (PVV) was calculated after eight weeks under third conditions (High intensity training, Moderate intensity training and No training intervention [control group] ).
measure: Body weight
timeFrame: At baseline and after eight weeks of the training intervention.
measure: Height
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Body fat
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Body mass index
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
measure: Waist circumference
timeFrame: At baseline and at week 9 (after the eight weeks of the training intervention).
Secondary outcomes:
Other outcomes:
Locations:
city: Kef
country: Tunisia
facility: High Institute of Sports and Physical Education of Kef
state: Boulifa
Study officials:
affiliation: Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.
name: Wissal abassi, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.
name: Antonella MUSCELLA, Professor
role: PRINCIPAL_INVESTIGATOR
References: