Strength Training as Prevention and Treatment of Late Effects in Long-term Survivors of Pediatric HSCT. (STEPS)

May 6, 2026 updated by: Klaus Gottlob Müller, Rigshospitalet, Denmark

Today the overall survival of childhood cancers has increased to above 85%. This increase is partially caused by treatment with bone marrow transplantation. A bone marrow transplantation is an efficient treatment against high-risk leukemia, as well as other life-threatening immunological and hematological diseases. However, it is unfortunately also related to the risk of developing a long series of late effects during early adulthood, such as low muscle mass, cardiovascular disease and diabetes. Conditions known from the older generations of the general population and also conditions highly related to lifestyle factors in the general population.

In the group of survivors after bone marrow transplantation, the cause for these late effects is not fully understood, as the same close association to lifestyle factors as seen in the general population, is not present in this group. Multiple studies have examined the possible causes, and it have been shown that certain elements of a bone marrow transplantation, ie. total body irradiation, are associated with the risk of developing late effects. As the cause is not fully understood, it is not known whether the treatment and preventive strategies, that would be applied in the general population for these conditions, are effective in this group.

Therefore, in this study the investigators aim at examining the effect of a strength training intervention on the development of the aforementioned late effects to treatment with bone marrow transplantation during childhood.

The investigators will invite a group of persons, transplanted during childhood, as well as an age- and sex-matched control group to participate in the study. Both groups will go through a 16-week strength training intervention, and a thorough health examination before and after the intervention, to assess metabolic status and body composition.

If the investigators find a positive effect of strength training on muscle mass and risk factors for developing cardiovascular disease and diabetes in persons, treated with bone marrow transplantation during childhood, it will support the implementation of structured training programs in the follow-up of these patients. Thereby hopefully contributing to an increased quality of life, as well as an increased life expectancy in the group of survivors after bone marrow transplantation during childhood.

Study Overview

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Copenhagen, Denmark, 2100
        • University Hospital Copenhagen - Rigshospitalet

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Living in Copenhagen, Denmark or surrounding area - making it possible to engage in strength training 3 times a week at Bispebjerg Hospital, Copenhagen, Denmark.
  • ≥ 18 years old

Exclusion Criteria:

  • Illness or physical handicap making it impossible to participate in the training intervention
  • Pregnancy
  • Not Danish or English speaking
  • Anemia
  • Already performing regular structured physical training
  • Strict vegan or vegetarian diet
  • Illness or ongoing treatment that hinders study examinations

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Strength training
In this arm participants will go through the "Strength training intervention".
The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in cross sectional area of m. quadricpes femoris.
Time Frame: 1 week pre intervention
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
1 week pre intervention
Changes in cross sectional area of m. quadricpes femoris.
Time Frame: 1 week post intervention
Muscle mass as measured by cross sectional area of m. quadriceps femoris at midthigh level, on an MRI scan.
1 week post intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in components of the Metabolic Syndrome: Waist circumference
Time Frame: 1 week pre intervention
Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week pre intervention
Changes in components of the Metabolic Syndrome: Waist circumference
Time Frame: 1 week post intervention
Waist circumference will be measured at the level of the superior border of the iliac crest, at the end of a normal expiration with a tape measure to the nearest 0.1 cm, as suggested by The US National Cholesterol Education Programme. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week post intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Time Frame: 1 week pre intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week pre intervention
Changes in components of the Metabolic Syndrome: Triglycerides
Time Frame: 1 week post intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week post intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time Frame: 1 week pre intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week pre intervention
Changes in components of the Metabolic Syndrome: HDL-cholesterol
Time Frame: 1 week post intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week post intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Time Frame: 1 week pre intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week pre intervention
Changes in components of the Metabolic Syndrome: Fasting glucose
Time Frame: 1 week post intervention
Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand. Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.
1 week post intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Time Frame: 1 week pre intervention

Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.

Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

1 week pre intervention
Changes in components of the Metabolic Syndrome: Blood pressure
Time Frame: 1 week post intervention

Blood pressure will be measured on the upper arm while sitting in the suppine position, after 10 minutes of rest, with an automated blood pressure monitor. Blood pressure will be measured three times, or untill there is less than 10 mmHg difference between measurements. The final blood pressure will be a mean of the two last measurements.

Patients will be classified according to The US National Cholesterol Education Programme Adult Treatment Panel III (NCEP ATP III) definition of the Metabolic Syndrome. We will report changes in the number of components fulfilled.

1 week post intervention
Hip circumference
Time Frame: 1 week pre intervention
Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
1 week pre intervention
Hip circumference
Time Frame: 1 week post intervention
Measurement of hip circumference at the widest part of the buttocks with a tape measure, to the nearest 0.1 cm.
1 week post intervention
Urine sample - microalbuminurea
Time Frame: 1 week pre intervention
A urine sample for analyses of microalbuminurea in mg/L.
1 week pre intervention
Urine sample - microalbuminurea
Time Frame: 1 week post intervention
A urine sample for analyses of microalbuminurea in mg/L.
1 week post intervention
Muscle strength of quadriceps femoris
Time Frame: 1 week pre intervention
Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
1 week pre intervention
Muscle strength of quadriceps femoris
Time Frame: 1 week post intervention
Rate of force development, maximal isometric and dynamic force capacity measured by KinCom Dynamometer
1 week post intervention
Handgrip strength
Time Frame: 1 week pre intervention
Handgrip strength measured with handheld Dynamometer
1 week pre intervention
Handgrip strength
Time Frame: 1 week post intervention
Handgrip strength measured with handheld Dynamometer
1 week post intervention
Muscle performance: Timed-up-and-go
Time Frame: 1 week pre intervention
Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.
1 week pre intervention
Muscle performance: Timed-up-and-go
Time Frame: 1 week post intervention
Timed-up-and-go test: The participant sits on a chair, that allow the participant to flex the leg at a 90 degree angle, with the back against the chair and arms on the knees. From this position the participant stands up straight and walk 3 m, turns around and go back to the chair and sit down as fast as possible, time in seconds is the outcome. The lowest score of three consecutive tries will be used in the analysis.
1 week post intervention
Muscle performance: Sit-to-stand 30 sec.
Time Frame: 1 week pre intervention
Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
1 week pre intervention
Muscle performance: Sit-to-stand 30 sec.
Time Frame: 1 week post intervention
Sit-to-Stand 30 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 30 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
1 week post intervention
Muscle performance: Sit-to-stand 60 sec.
Time Frame: 1 week pre intervention
Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
1 week pre intervention
Muscle performance: Sit-to-stand 60 sec.
Time Frame: 1 week post intervention
Sit-to-Stand 60 sec: The participant sits on a chair allowing the participant to flex the legs at a 90 degree angle. The participant is instructed to stand up straight, and return to sitting, as many times as possible in 60 sec. The arms should be crossed in front of the body or hanging by the side. Number of repititions is the outcome.
1 week post intervention
Cardiorespiratory fitness: 6 minute walk test
Time Frame: 1 week pre intervention
6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.
1 week pre intervention
Cardiorespiratory fitness: 6 minute walk test
Time Frame: 1 week post intervention
6 min. walk test: The participant walks as far as possible on a 15 m lane in 6 min. Distance in meters is the outcome.
1 week post intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Histology of thigh muscle
Time Frame: 1 week pre intervention
Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.
1 week pre intervention
Histology of thigh muscle
Time Frame: 1 week post intervention
Muscle biopsy sampled from the vastus lateralis muscle, with a Bergstroem needle with manual suction.
1 week post intervention
Body composition: Intraabdominal visceral fat
Time Frame: 1 week pre intervention
Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
1 week pre intervention
Body composition: Intraabdominal visceral fat
Time Frame: 1 week post intervention
Amount of visceral fat intraabdominally, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
1 week post intervention
Body composition: Abdominal subcutaneous fat
Time Frame: 1 week pre intervention
Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
1 week pre intervention
Body composition: Abdominal subcutaneous fat
Time Frame: 1 week post intervention
Amount of subcutaneous fat in the abomen region, as measured on a multisectional MRI scan from diaphragma to the pelvis with Dixon sequences.
1 week post intervention
Body composition: Hepatic fat
Time Frame: 1 week pre intervention
Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.
1 week pre intervention
Body composition: Hepatic fat
Time Frame: 1 week post intervention
Amount of hepatic fat (%), as measured on a MRI scan fromof the liver with Dixon sequences.
1 week post intervention
Body composition: Fat mass
Time Frame: 1 week pre intervention
Body fat mass (%) will be analyzed on a whole-body DEXA scan
1 week pre intervention
Body composition: Fat mass
Time Frame: 1 week post intervention
Body fat mass (%) will be analyzed on a whole-body DEXA scan
1 week post intervention
Body composition: Fat free mass
Time Frame: 1 week pre intervention
Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan
1 week pre intervention
Body composition: Fat free mass
Time Frame: 1 week post intervention
Fat free mass (%), as a surrogate measure of lean mass, will be analyzed on a whole-body DEXA scan
1 week post intervention
Body composition: Android-gynoid ratio
Time Frame: 1 week pre intervention
Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan
1 week pre intervention
Body composition: Android-gynoid ratio
Time Frame: 1 week post-intervention
Android-gynoid ratio will be calculated, as a ratio of the fat mass in the abdominal region and the fat mass in the hip area, obtained by a whole-body DEXA scan
1 week post-intervention
Body composition: Bone mineral density
Time Frame: 1 week pre intervention
Bone mineral density, will be analyzed on a whole-body DEXA scan. Z- and T-scores will be calculated.
1 week pre intervention
Body composition: Bone mineral density
Time Frame: 1 week post intervention
Bone mineral density, will be analyzed on a whole-body DEXA scan. Z- and T-scores will be calculated.
1 week post intervention
Body mass index (BMI)
Time Frame: 1 week pre intervention
BMI will be calculated based on measurements of height and weight. To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm. Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes. BMI is calculated as wieght in kg diveded by height in meters squared.
1 week pre intervention
Body mass index (BMI)
Time Frame: 1 week post intervention
BMI will be calculated based on measurements of height and weight. To measure height the participants will stand up straight against a wall, in bare feet looking straight forward, and will be measured to the nearest 0.1 cm. Weight will be measured on an automated weight wearing only light indoor clothing with empty pockets and no shoes. BMI is calculated as wieght in kg diveded by height in meters squared.
1 week post intervention
Total-cholesterol
Time Frame: 1 week pre intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Total-cholesterol
Time Frame: 1 week post intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
LDL-cholesterol
Time Frame: 1 week pre intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
LDL-cholesterol
Time Frame: 1 week post intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Adipokines: Adiponectin
Time Frame: 1 week pre intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Adipokines: Adiponectin
Time Frame: 1 week post intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Adipokines: Leptin
Time Frame: 1 week pre intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Adipokines: Leptin
Time Frame: 1 week post intervention
Will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Growth factors
Time Frame: 1 week pre intervention
Growth factors, i.e. IGF-1 and IGFBP-3, will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Growth factors
Time Frame: 1 week post intervention
Growth factors, i.e. IGF-1 and IGFBP-3, will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Thyroid hormones
Time Frame: 1 week pre intervention
Thyroid hormones, free triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Thyroid hormones
Time Frame: 1 week post intervention
Thyroid hormones, triiodothyronine (T3) and thyroxine (T4) as well as thyroid stimulating hormone (TSH) will be analyzed in a plasma sample. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Sex hormones
Time Frame: 1 week pre intervention
Analyses of sex hormones, including testosterone and estrogen levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Sex hormones
Time Frame: 1 week post intervention
Analyses of sex hormones, including testosterone and estrogen levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Markers of inflammation
Time Frame: 1 week pre intervention
Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week pre intervention
Markers of inflammation
Time Frame: 1 week post intervention
Analyses of markers of inflammation, including high sensitivity CRP and IL-6 levels. Blood samples will be drawn from a cannual placed in an antecubital vein or a dorsal vein in the hand.
1 week post intervention
Oral glucose tolerance test: Glucose
Time Frame: 1 week pre intervention
Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Glucose
Time Frame: 1 week post intervention
Analyses of plasma glucose levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Oral glucose tolerance test: Insulin
Time Frame: 1 week pre intervention
Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Insulin
Time Frame: 1 week post intervention
Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Oral glucose tolerance test: C-peptide
Time Frame: 1 week pre intervention
Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: C-peptide
Time Frame: 1 week post intervention
Analyses of plasma insulin levels during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Oral glucose tolerance test: Gut hormones
Time Frame: 1 week pre intervention
Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Gut hormones
Time Frame: 1 week post intervention
Analyses of plasma levels of gut hormones, including GLP-1, GIP and glucagon during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Oral glucose tolerance test: Bone remodeling markers
Time Frame: 1 week pre intervention
Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Bone remodeling markers
Time Frame: 1 week post intervention
Analyses of plasma levels of bone remodeling markers, including CTX and P1NP during a 3 hour oral glucose tolerance test. Blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Health related quality of life - SF36
Time Frame: 1 week pre intervention
Measure of health related quality of life, by the validated questionnaire SF-36. Outcome will be total score based o the questionnaire.
1 week pre intervention
Health related quality of life - SF36
Time Frame: 1 week post intervention
Measure of health related quality of life, by the validated questionnaire SF-36. Outcome will be total score based o the questionnaire.
1 week post intervention
Accelerometry using actigraph
Time Frame: 1 week pre intervention
measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day
1 week pre intervention
Accelerometry using actigraph
Time Frame: 1 week post intervention
measure of physical activity and sedentary behavior measured over 7 days recorded as counts per day and minutes in moderate to vigorous activity
1 week post intervention
Oral glucose tolerance test: Matsuda Index
Time Frame: 1 week pre intervention
Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Matsuda Index
Time Frame: 1 week post intervention
Based on glucose and insulin values from the OGTT the Matsuda Index will be calculated, as a measure of peripheral insulin sensitivity. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention
Oral glucose tolerance test: Insulinogenic Index
Time Frame: 1 week pre intervention
Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week pre intervention
Oral glucose tolerance test: Insulinogenic Index
Time Frame: 1 week post intervention
Based on glucose and insulin values from the OGTT the insulinogenic Index will be calculated, as a measure of beta-cell function. For the OGTT blood samples will be drawn before and 7, 15, 30, 45, 60, 90, 120, 150 and 180 minutes after the intake of 75 g of glucose disolved in 250 ml of water.
1 week post intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 8, 2021

Primary Completion (Actual)

June 21, 2022

Study Completion (Actual)

June 24, 2022

Study Registration Dates

First Submitted

June 4, 2021

First Submitted That Met QC Criteria

June 4, 2021

First Posted (Actual)

June 11, 2021

Study Record Updates

Last Update Posted (Actual)

May 11, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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