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Completed

NCT Number: NCT07019285

Interval Training and Plasma Volume Variation

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.

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Key information

Conditions

Hematologic Tests Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

45 year–59 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

High Institute of Sports and Physical Education of Kef

El Kef, Boulifa, 7100, Tunisia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. Erythrocytes

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

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

  2. Hemoglobin

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

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

  3. Hematocrit

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

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

  4. Mean corpuscular volume

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

    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).

  5. Mean corpuscular hemoglobin content

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

    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)

  6. Mean hemoglobin concentration

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

    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).

  7. Creatine kinase

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

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

  8. Lactate dehydrogenase

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

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

  9. Plasma volume variations

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

    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.

  10. Body weight

    Time frame: At baseline and after eight weeks of the training intervention.

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

  11. Height

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

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

  12. Body fat

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

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

  13. Body mass index

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

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

  14. Waist circumference

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

    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.

Sponsors and collaborators

Lead sponsor

Wissal Abassi

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 13, 2025
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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