Hematologic TestsNCT07019285
Interval Training and Plasma Volume Variation
A study testing High intensity interval walking training and Moderate-intensity interval walking training in people with Hematologic Tests, run by Wissal Abassi at 1 site in Tunisia.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 59 years, women only
- Conditions the study is for
- Hematologic Tests
- What is being tested?
- High intensity interval walking training and Moderate-intensity interval walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteTunisia
- Study dates
- 6 Jan 2025to 16 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 59 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- Medical contraindications to physical activity, diagnosed metabolic, hormonal, orthopedic, or cardiovascular conditions.
- Current use of hormone replacement therapy or any prescribed medication.
Trial locations and contacts
1 site in 1 country.
Tunisia1 site
High Institute of Sports and Physical Education of Kef
El Kef, Boulifa, 7100
About this study
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
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.
Read the 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
- Being tested
- High intensity interval walking training, Moderate-intensity interval walking training
- Keywords
- Hematocrit, Plasma volume variation, Interval walking training, Lactate dehydrogenase, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensity interval walking trainingBehavioural
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 trainingBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Behavioral: Moderate-intensity interval walking training |
| Control group | No intervention | No training intervention was intended for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: At baseline and after eight weeks of the training intervention.
Height
Height (m) was determined using a standard stadiometer (Holtain Ltd., UK).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: At baseline and at week 9 (after the eight weeks of the training intervention).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start6 Jan 2025
- Primary completion16 Mar 2025
- Study completion16 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wissal Abassi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Wissal Abassi, High Institute of Sports and Physical Education of Kef
- Investigators
- Wissal abassi, Dr, 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, Principal investigator, Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019285
- Sponsor's protocol ID
- Hematological markers
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For confidentiality reasons, all data from this study are available upon request.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07019285
- Acronym / sponsor ID
- Hematological markers
- Conditions
- Hematologic Tests
- Keywords
- Hematocrit, Plasma volume variation, Interval walking training, Lactate dehydrogenase, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wissal AbassiUniversity, hospital or other
- Study start
- 6 Jan 2025 (actual)
- Primary completion
- 16 Mar 2025 (actual)
- Study completion
- 16 Mar 2025 (actual)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High-intensity intermittent walking training group | Experimental | Behavioral: High intensity interval walking trainingperformed five 6-minute walking bouts at 90-110% of the 6-minute walking test distance (6MWTD) with 6-min of active recovery between repetitions |
| Moderate-intensity intermittent walking training group | Experimental | Behavioral: Moderate-intensity interval walking trainingrepeated five 6-minute walking intervals at 60-80% of 6MWTD interspersed with 6 minutes of active recovery between repetition |
| Control group | No intervention | –No training intervention was intended for the control group. |
Who may qualify
- Ages
- 45 to 59 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Medical contraindications to physical activity, diagnosed metabolic, hormonal, orthopedic, or cardiovascular conditions.
- Current use of hormone replacement therapy or any prescribed medication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensity interval walking trainingHigh 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 | Behavioural | High-intensity intermittent walking training group |
| Moderate-intensity interval walking trainingModerate 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 | Behavioural | Moderate-intensity intermittent walking training group |
Primary outcome
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).
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).
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).
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).
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)
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).
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).
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).
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.
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).
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).
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).
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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Individual participant dataSharing planned: No. For confidentiality reasons, all data from this study are available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wissal abassi, Dr 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 principal investigator
Department of Biological and Environmental Science and Technologies (DiSTeBA), University of Salento, 73100 Lecce, Italy.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High intensity interval walking training and Moderate-intensity interval walking training in people with Hematologic Tests, run by Wissal Abassi at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Erythrocytes (time frame: At baseline and at week 9 (after the eight weeks of the training intervention).). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2025.