Interval Training and Plasma Volume Variation

NCT ID: NCT07019285

Last Updated: 2025-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-06
• Study Completion Date: 2025-03-16

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).

Conditions

Hematologic Tests

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

High-intensity intermittent walking training group

performed five 6-minute walking bouts at 90-110% of the 6-minute walking test distance (6MWTD) with 6-min of active recovery between repetitions

Group Type: EXPERIMENTAL

High intensity interval walking training

Intervention Type: BEHAVIORAL

High intensity intermittent walking training for a period of 8 weeks. The intensity of the training is 90 to 110% of 6MWTdistance. The frequency of the training is three times a week

Moderate-intensity intermittent walking training group

repeated five 6-minute walking intervals at 60-80% of 6MWTD interspersed with 6 minutes of active recovery between repetition

Group Type: EXPERIMENTAL

Moderate-intensity interval walking training

Intervention Type: BEHAVIORAL

Moderate intensity intermittent walking training for a period of 8 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is three times a week

Control group

No training intervention was intended for the control group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

High intensity interval walking training

High intensity intermittent walking training for a period of 8 weeks. The intensity of the training is 90 to 110% of 6MWTdistance. The frequency of the training is three times a week

Intervention Type: BEHAVIORAL

Moderate-intensity interval walking training

Moderate intensity intermittent walking training for a period of 8 weeks. The intensity of the training is 60 to 80% of 6MWTdistance. The frequency of the training is three times a week

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Wissal Abassi

OTHER

Sponsor Role: lead

Responsible Party

Wissal Abassi

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Wissal abassi, Dr

Role: PRINCIPAL_INVESTIGATOR

Research Unit "Sport Sciences, Health and Movement"(UR22JS01) High Institute of Sport and Physical Education of Kef, University of Jendouba, 7100 Kef, Tunisia.

Antonella MUSCELLA, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.

Locations

High Institute of Sports and Physical Education of Kef

El Kef, Boulifa, Tunisia

Countries

Tunisia

Other Identifiers

Hematological markers

Identifier Type: -

Identifier Source: org_study_id