Interval Training and Plasma Volume Variation

NCT07019285 | Completed DMC

• 1 other identifier: Hematological markers
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Tests

Keywords

Hematocrit; Plasma volume variation; Interval walking training; Lactate dehydrogenase; Obesity

Outcome Measures

Primary Outcomes (14)

• Erythrocytes

  Blood levels of erythrocytes were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Hemoglobin

  Blood levels of hemoglobin were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Hematocrit

  Blood levels of hematocrit were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Mean corpuscular volume

  Blood levels of mean corpuscular volume were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Mean corpuscular hemoglobin content

  Description: Blood levels of mean corpuscular hemoglobin content were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany). Time Frame: At baseline and at week 9 (after the eight weeks of the training intervention)

  At baseline and at week 9(after the eight weeks of the training intervention)

• Mean hemoglobin concentration

  Blood levels of mean hemoglobin concentration were collected from a blood sample (5 ml) and analyzed using a multichannel automated hematology analyzer (XN450; Sysmex, Norderstedt, Germany).

  At baseline and at week 9 (after the eight weeks of the training intervention)

• Creatine kinase

  Serum concentrations of creatine kinase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Lactate dehydrogenase

  Serum concentrations of lactate dehydrogenase are measured from a blood sample (5 ml) using a Beckman Coulter AU480 Chemistry Analyzer (France).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Plasma volume variations

  Plasma volume variations (PVV) was calculated based on measured hematocrit (Ht) and hemoglobin (Hb) values according to the method developed by Dill and Fink (1974). %PVV=100 ×\[(Hb0/Hb1) ×(100 - Ht1) / (100 - Ht0)\] - 1, where 0 is the value measured before training program and 1 is the value measured after training program.

  Plasma volume variations (PVV) was calculated after eight weeks under third conditions (High intensity training, Moderate intensity training and No training intervention [control group] ).

• Body weight

  Body weight (kg) was recorded , with barefoot and lightly dressed subjects, using an electronic scale (Tanita BC-533, Tokyo, Japan).

  At baseline and after eight weeks of the training intervention.

• Height

  Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Body fat

  Body fat (%) was recorded using an electronic scale (Tanita BC-533, Tokyo, Japan).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Body mass index

  Body mass index (kg/m²) was calculated as weight (kg) divided by height squared (m²).

  At baseline and at week 9 (after the eight weeks of the training intervention).

• Waist circumference

  Waist circumference (cm) was measured to the nearest 0.1 cm using a non-deformable anthropometric tape, placed horizontally at the midpoint between the inferior margin of the last palpable rib and the superior border of the iliac crest, with the participant standing upright and breathing normally.

  At baseline and at week 9 (after the eight weeks of the training intervention).

Study Arms (3)

High-intensity intermittent walking training group

EXPERIMENTAL

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

Behavioral: High intensity interval walking training

Moderate-intensity intermittent walking training group

EXPERIMENTAL

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

Behavioral: Moderate-intensity interval walking training

Control group

NO INTERVENTION

No training intervention was intended for the control group.

Interventions

High intensity interval walking training 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

High-intensity intermittent walking training group

Moderate-intensity interval walking training 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

Moderate-intensity intermittent walking training group

Eligibility Criteria

• Age: 45 Years - 59 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

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

Sponsors & Collaborators

• Wissal Abassi: lead

Study Sites (1)

High Institute of Sports and Physical Education of Kef

El Kef, Boulifa, 7100, Tunisia

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Wissal abassi, Dr

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

  PRINCIPAL INVESTIGATOR

• Antonella MUSCELLA, Professor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 13, 2025
• Study Start: January 6, 2025
• Primary Completion: March 16, 2025
• Study Completion: March 16, 2025
• Last Updated: June 17, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)