Metabolic SyndromeACTNCT01642680
Optimal Timing of Physical Activity in Cancer Treatment
A study testing A tailored physical activity program during chemotherapy and A tailored physical activity program after chemotherapy in people with Metabolic Syndrome and Vascular Disorders, run by University Medical Center Groningen at 1 site in Netherlands.
Trial summary
The number of long-term cancer survivors is growing. As a result, treatment-related morbidity - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is impacting quality of life and impairing survival. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Syndrome, Vascular Disorders, Cardiovascular Risk Factors
- What is being tested?
- A tailored physical activity program during chemotherapy and A tailored physical activity program after chemotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteNetherlands
- Study dates
- 24 Jan 2013to 22 Oct 2020
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with testicular, early colon, breast cancer or B-NHL with an indication for systemic chemotherapy with a curative intent
- Normal blood count at start of systemic treatment
- Patients need to have an adequate physical health, which is defined by diastolic blood pressure >45 mm Hg or <95 mm Hg; heart frequency in at rest < 100 per minute; body temperature below 38°C; respiration frequency in rest below 20 per minute
- Adequate cardiac function with a LVEF above the lower limit of normal
- Written informed consent
Who cannot join
- Infections requiring actual antibiotics
- Signs of ongoing bleeding or fresh petechiae; unexplained bruises
- Critical organ impairment due to their malignancy
- Not recovered from earlier surgical intervention
- Non adequate control of any symptoms of the malignancy
- Inability to travel independently to the rehabilitation centre
- Cognitive disorder or emotional instability that might impede the participation in the training program
- Recent cardiovascular event
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity
The number of long-term cancer survivors is growing. As a result, treatment-related morbidity - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is impacting quality of life and impairing survival. Metabolic syndrome in the general population is currently treated with lifestyle advice to increase physical activity (PA) and reduce caloric intake. This approach is still underused as standard care for cancer survivors. The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy).
Read the detailed description
Improved treatment is partly responsible for the increased survival and life expectancy in cancer patients. However, such treatment can be harmful as well, and cancer survivors therefore, face an increased risk of second malignancies and other chronic diseases, e.g. cardiovascular diseases and metabolic syndrome.
Due to the growing number of cancer patients and survivors, attention for rehabilitation, especially physical training, is growing. Several meta-analyses show the beneficial effects of physical training on several outcomes such as physical fitness, muscle strength, fatigue and quality of life, and a few studies showed the effect of exercise on physical active behaviour. However, studies on the effect of timing of exercise are lacking.
The present study aims to insert a tailored physical activity program early versus late in the chemotherapy based cancer treatment and will yield data about its safety and efficacy. We hypothesize that a tailored physical activity program during early cancer treatment may more be effective to reduce long-term cancer treatment toxicities and morbidity in cancer survivors compared to a program after cancer treatment.
Primary Objective: To investigate whether a tailored physical activity program that starts during chemotherapy (early) is superior in terms of physical fitness, as determined by VO2 peak at one year, to a program that starts after completion of chemotherapy (late).
Secondary Objectives: To examine the effect of the physical activity program on muscle strength and activity level, change in metabolic and cardiovascular damage parameters, cardiovascular risk factors and quality of life including self-efficacy, motivation for exercise, and fatigue.
Design: This protocol describes a multicenter, randomized study with 2 arms. Patients who will be treated with curative systemic chemotherapeutic treatment for testicular cancer, early colon cancer, early breast cancer or B-NHL will be randomized into an early or late PA program group. The early group will start the PA program during chemotherapy (for 12 weeks) until 12 weeks after completion of chemotherapy (total 24 weeks of training). The late group will start the same program (total of 12 weeks) after completion of chemotherapy. The longitudinal effects of the physical activity (PA) program for all participants will be evaluated at different time points in the UMCG: before start of chemotherapeutic treatment; at the start of the PA program and at 3, 6, 18 months after starting the PA program and 18 months after the last chemotherapy.
- Being tested
- A tailored physical activity program during chemotherapy, A tailored physical activity program after chemotherapy
- Keywords
- Physical activity program, Chemotherapy, Metabolic syndrome, Reducing cardiovascular risk factors, low physical activity level
- Medical subject headings
- Metabolic Syndrome, Vascular Diseases, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
A tailored physical activity program during chemotherapyOther
The early group will start the PA program during chemotherapy for 3 months, and after completion of chemotherapy for 3 months (total 6 months). The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
A tailored physical activity program after chemotherapyOther
The late group will start the PA program after completion of the chemotherapy for 6 months. The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity during chemotherapy | Experimental | This group will start with a physical activity program 3 months before the end of their chemotherapeutic regimen. After chemotherapy they will continue the PA program for another 3 months. Receives: Other: A tailored physical activity program during chemotherapy |
| Physical activity after chemotherapy | Active comparator | This group will start with a physical activity program after the end of their chemotherapeutic regimen. The physical activity program wil take 6 months to complete. Receives: Other: A tailored physical activity program after chemotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET).
The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy).
The VO2 at the peak of the exercise will be defined as peak oxygen uptake (VO2 peak), measured by cardiopulmonary exercise testing (CPET) on a stationary bicycle ergometer. The CPET is considered to be the most precise measure of cardio-respiratory fitness and is recommended for use in order to determine a patient's objective or subjective difference in exercise capacity
Measured: 1,5 year
Secondary outcomes (26)
Muscle strength using a hand-held dynamometer
Maximal voluntary isometric muscle force of the right and left extremity of extension of the knee, flexion of the knee, flexion of the elbow and extension of the elbow will be measured using a hand-held dynamometer. The "break method" will be used for all measurements. To employ this technique, the examiner gradually overcomes the force exerted by the patient until the extremity gives way. All measurements will be performed at least three times, with recovery intervals of at least 10 seconds. The peak forces (in Newtons) will be recorded and mean values of three technically correct measurements will be taken for analysis.
Measured: 1,5 year
Intima media thickness will be measured with vascular ultrasound
Vascular damage will be determined with the intima-media thickness (IMT) of the common carotid artery and femoral artery, performed with an Ultrasound technique.
Measured: 1,5 year
Cholesterol levels, measured in blood
Measured in blood, in mmol/L
Measured: 1,5 year
Triglyceride levels, measured in blood
Measured in blood, in mmol/L
Measured: 1,5 year
Glucose levels, measured in blood
Measured in blood, in mmol/L
Measured: 1,5 year
Body mass index, calculated with formula (see below)
BMI (body mass index): weight in kilograms divided by height in meters squared
Measured: 1,5 year
Health related quality of life measured with the EORTC QLQ-C30
Quality of life will be measured with the European Organization for Research and Treatment of Cancer (EORTC), Quality of Life Questionnaire Core 30 (QLQ-C30) version 3.0 questionnaire
Measured: 1,5 year
Patient reported self-efficacy measured using the ALCOS instrument
Patient reported general self-efficacy, measuring the patients' expectations of their general capacities, will be evaluated using the Dutch version of the General Self-Efficacy Scale (GSES), the "Algemene Competentie Schaal" (ALCOS)
Measured: 1 year
Patient reported fatigue measured with the Multi-dimensional Fatigue Inventory
The Multi-dimensional Fatigue Inventory is a validated 20-item questionnaire on different domains of fatigue
Measured: 1,5 year
Patient reported physical activity level with the PASE questionnaire
Physical activity will be assessed with the Sum score of the Physical Activity Scale for the Elderly questionnaire (PASE). This questionnaire consists of questions on leisure time, household and work-related activities.
Measured: 1,5 year
DNA collection
Whole blood will be drawn of patients and collected in EDTA tubes. DNA isolations and the Global Screening Array will be performed at the Human Genomics Facility (HuGeF) of the Genetic Laboratory of the Department of Internal Medicine at Erasmus MC, Rotterdam, the Netherlands
Measured: 1,5 year
Diffusion capacity of the lungs
Corrected for hemoglobin.
Measured: 1,5 year
Forced vital capacity (FVC) will be assessed by use of dynamic spirometry
Measured by means of dynamic spirometry
Measured: 1,5 year
Forced expiratory volume in one second (FEV1) will be assessed by use of dynamic spirometry,
Measured by means of dynamic spirometry
Measured: 1,5 year
FEV1/FVC ratio will be assessed by use of dynamic spirometry,
Measured by means of dynamic spirometry
Measured: 1,5 year
Senescence with markers of the senescence- associated secretory phenotype
Senescence will be measured in a subset of testicular cancer patients.
Markers of scenescence will be obtained from a skin biopsy and fat biopsy. Also, additional blood samples will be assessed to establish markers of the senescence- associated secretory phenotype.
Measured: 1,5 year
Cardiac function with echocardiography (Ultrasound technique)
Cardiac function will be measured at baseline and at the final measurement (e.g. left ventricular ejection fraction)
Measured: 1,5 year
Body composition will be assessed with a DEXA scan
With the DEXA scan, measurements of body composition will be obtained.
Measured: 1,5 year
PAI-antigen, measured in blood serum
Endothelial activation will be determined with PAI antigen in blood serum, in ug/L
Measured: 1,5 year
t-PA, measured in blood serum
Endothelial activation will be determined with t-PA antigen in blood serum, in ug/L
Measured: 1,5 year
Factor VIII, measured in blood serum
Endothelial activation will be determined with factor VIII in blood serum, in %
Measured: 1,5 year
Von Willebrand factor, measured in blood serum
Endothelial activation will be determined with von Willebrand facor in blood serum, in %
Measured: 1,5 year
Fibrinogen, measured in blood serum
Endothelial activation will be determined with fibrinogen in blood serum, in g/L
Measured: 1,5 year
Advanced glycation end products (AGEs) will be determined by measuring skin auto fluorescence.
Advanced glycation end products will be measured with an AGEreader
Measured: 1,5 year
Blood pressure, measured with a blood pressure cuff
Systolic and diastolic blood pressure in mmHg
Measured: 1,5 years
Fat percentage with skinfold measurement
Skinfold measurement of biceps, triceps, sub scapula and supra iliaca
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2012 (estimated)
- Study start24 Jan 2013
- Primary completion22 Oct 2020
- Study completion22 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Annemiek Walenkamp, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01642680
- Sponsor's protocol ID
- 2012-0010
- Other IDs
- 41087
- Acronym
- ACT
- Status last verified
- May 2024
- First submitted
- 4 Jul 2012
- Last updated
- 6 May 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
van der Schoot GGF, Ormel HL, Westerink NL, Wempe JB, Lefrandt JD, May AM, Vrieling AH, Meijer C, Gietema JA, Walenkamp AME. Physical exercise in patients with testicular cancer treated with bleomycin, etoposide and cisplatin chemotherapy: pulmonary and vascular endothelial function-an exploratory analysis. J Cancer Res Clin Oncol. 2023 Dec;149(19):17467-17478. doi: 10.1007/s00432-023-05469-5. Epub 2023 Oct 27.
PubMed 37889308van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
PubMed 36444224
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Timing of a Tailored Physical Activity Program During Chemotherapeutic Cancer Treatment to Reduce Long-term Cardiovascular Morbidity
- ClinicalTrials.gov ID
- NCT01642680
- Acronym / sponsor ID
- ACT / 2012-0010
- Keywords
- Physical activity program, Chemotherapy, Metabolic syndrome, Reducing cardiovascular risk factors, low physical activity level
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- 24 Jan 2013 (actual)
- Primary completion
- 22 Oct 2020 (actual)
- Study completion
- 22 Oct 2020 (actual)
- First posted
- 17 Jul 2012 (estimated)
- 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 number of long-term cancer survivors is growing. As a result, treatment-related morbidity - such as cardiovascular disease, metabolic syndrome, functional decline and fatigue - is impacting quality of life and impairing survival. Metabolic syndrome in the general population is currently treated with lifestyle advice to increase physical activity (PA) and reduce caloric intake. This approach is still underused as standard care for cancer survivors. The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy).
Detailed description
Improved treatment is partly responsible for the increased survival and life expectancy in cancer patients. However, such treatment can be harmful as well, and cancer survivors therefore, face an increased risk of second malignancies and other chronic diseases, e.g. cardiovascular diseases and metabolic syndrome.
Due to the growing number of cancer patients and survivors, attention for rehabilitation, especially physical training, is growing. Several meta-analyses show the beneficial effects of physical training on several outcomes such as physical fitness, muscle strength, fatigue and quality of life, and a few studies showed the effect of exercise on physical active behaviour. However, studies on the effect of timing of exercise are lacking.
The present study aims to insert a tailored physical activity program early versus late in the chemotherapy based cancer treatment and will yield data about its safety and efficacy. We hypothesize that a tailored physical activity program during early cancer treatment may more be effective to reduce long-term cancer treatment toxicities and morbidity in cancer survivors compared to a program after cancer treatment.
Primary Objective: To investigate whether a tailored physical activity program that starts during chemotherapy (early) is superior in terms of physical fitness, as determined by VO2 peak at one year, to a program that starts after completion of chemotherapy (late).
Secondary Objectives: To examine the effect of the physical activity program on muscle strength and activity level, change in metabolic and cardiovascular damage parameters, cardiovascular risk factors and quality of life including self-efficacy, motivation for exercise, and fatigue.
Design: This protocol describes a multicenter, randomized study with 2 arms. Patients who will be treated with curative systemic chemotherapeutic treatment for testicular cancer, early colon cancer, early breast cancer or B-NHL will be randomized into an early or late PA program group. The early group will start the PA program during chemotherapy (for 12 weeks) until 12 weeks after completion of chemotherapy (total 24 weeks of training). The late group will start the same program (total of 12 weeks) after completion of chemotherapy. The longitudinal effects of the physical activity (PA) program for all participants will be evaluated at different time points in the UMCG: before start of chemotherapeutic treatment; at the start of the PA program and at 3, 6, 18 months after starting the PA program and 18 months after the last chemotherapy.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physical activity during chemotherapy | Experimental | Other: A tailored physical activity program during chemotherapyThis group will start with a physical activity program 3 months before the end of their chemotherapeutic regimen. After chemotherapy they will continue the PA program for another 3 months. |
| Physical activity after chemotherapy | Active comparator | Other: A tailored physical activity program after chemotherapyThis group will start with a physical activity program after the end of their chemotherapeutic regimen. The physical activity program wil take 6 months to complete. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with testicular, early colon, breast cancer or B-NHL with an indication for systemic chemotherapy with a curative intent
- Normal blood count at start of systemic treatment
- Patients need to have an adequate physical health, which is defined by diastolic blood pressure >45 mm Hg or <95 mm Hg; heart frequency in at rest < 100 per minute; body temperature below 38°C; respiration frequency in rest below 20 per minute
- Adequate cardiac function with a LVEF above the lower limit of normal
- Written informed consent
Key exclusion criteria (8 listed)
- Infections requiring actual antibiotics
- Signs of ongoing bleeding or fresh petechiae; unexplained bruises
- Critical organ impairment due to their malignancy
- Not recovered from earlier surgical intervention
- Non adequate control of any symptoms of the malignancy
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 |
|---|---|---|
| A tailored physical activity program during chemotherapyThe early group will start the PA program during chemotherapy for 3 months, and after completion of chemotherapy for 3 months (total 6 months). The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period. | Other | Physical activity during chemotherapy |
| A tailored physical activity program after chemotherapyThe late group will start the PA program after completion of the chemotherapy for 6 months. The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period. | Other | Physical activity after chemotherapy |
Primary outcome
Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET).
Time frame: 1,5 year
The aim of this study is investigate whether a tailored PA program that starts early (during curative chemotherapy with cardiovascular toxic potential) is superior in terms of reducing long-term cancer-treatment-related metabolic syndrome and cardiovascular morbidity to a program that starts late (after completion of chemotherapy). The VO2 at the peak of the exercise will be defined as peak oxygen uptake (VO2 peak), measured by cardiopulmonary exercise testing (CPET) on a stationary bicycle ergometer. The CPET is considered to be the most precise measure of cardio-respiratory fitness and is recommended for use in order to determine a patient's objective or subjective difference in exercise capacity
26 secondary outcomes
Muscle strength using a hand-held dynamometer
Time frame: 1,5 year
Intima media thickness will be measured with vascular ultrasound
Time frame: 1,5 year
Cholesterol levels, measured in blood
Time frame: 1,5 year
Triglyceride levels, measured in blood
Time frame: 1,5 year
Glucose levels, measured in blood
Time frame: 1,5 year
Body mass index, calculated with formula (see below)
Time frame: 1,5 year
Health related quality of life measured with the EORTC QLQ-C30
Time frame: 1,5 year
Patient reported self-efficacy measured using the ALCOS instrument
Time frame: 1 year
Patient reported fatigue measured with the Multi-dimensional Fatigue Inventory
Time frame: 1,5 year
Patient reported physical activity level with the PASE questionnaire
Time frame: 1,5 year
DNA collection
Time frame: 1,5 year
Diffusion capacity of the lungs
Time frame: 1,5 year
Forced vital capacity (FVC) will be assessed by use of dynamic spirometry
Time frame: 1,5 year
Forced expiratory volume in one second (FEV1) will be assessed by use of dynamic spirometry,
Time frame: 1,5 year
FEV1/FVC ratio will be assessed by use of dynamic spirometry,
Time frame: 1,5 year
Senescence with markers of the senescence- associated secretory phenotype
Time frame: 1,5 year
Cardiac function with echocardiography (Ultrasound technique)
Time frame: 1,5 year
Body composition will be assessed with a DEXA scan
Time frame: 1,5 year
PAI-antigen, measured in blood serum
Time frame: 1,5 year
t-PA, measured in blood serum
Time frame: 1,5 year
Factor VIII, measured in blood serum
Time frame: 1,5 year
Von Willebrand factor, measured in blood serum
Time frame: 1,5 year
Fibrinogen, measured in blood serum
Time frame: 1,5 year
Advanced glycation end products (AGEs) will be determined by measuring skin auto fluorescence.
Time frame: 1,5 year
Blood pressure, measured with a blood pressure cuff
Time frame: 1,5 years
Fat percentage with skinfold measurement
Time frame: 1.5 years
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 6 May 2024.
- Derived from this study: PubMed 37889308van der Schoot GGF, Ormel HL, Westerink NL, Wempe JB, Lefrandt JD, May AM, Vrieling AH, Meijer C, Gietema JA, Walenkamp AME. Physical exercise in patients with testicular cancer treated with bleomycin, etoposide and cisplatin chemotherapy: pulmonary and vascular endothelial function-an exploratory analysis. J Cancer Res Clin Oncol. 2023 Dec;149(19):17467-17478. doi: 10.1007/s00432-023-05469-5. Epub 2023 Oct 27.
- Derived from this study: PubMed 36444224van der Schoot GGF, Ormel HL, Westerink NL, May AM, Elias SG, Hummel YM, Lefrandt JD, van der Meer P, van Melle JP, Poppema BJ, Stel JMA, van der Velden AWG, Vrieling AH, Wempe JB, Ten Wolde MG, Nijland M, de Vries EGE, Gietema JA, Walenkamp AME. Optimal Timing of a Physical Exercise Intervention to Improve Cardiorespiratory Fitness: During or After Chemotherapy. JACC CardioOncol. 2022 Oct 18;4(4):491-503. doi: 10.1016/j.jaccao.2022.07.006. eCollection 2022 Nov.
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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.
Annemiek Walenkamp, PhD principal investigator
University Medical Center Groningen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing A tailored physical activity program during chemotherapy and A tailored physical activity program after chemotherapy in people with Metabolic Syndrome and Vascular Disorders, run by University Medical Center Groningen at 1 site in Netherlands.
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 5 inclusion and 8 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 6 May 2024. 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 Netherlands. 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?
Difference in VO2 peak between the groups after completion of the PA program, measured by cardiopulmonary exercise testing (CPET). (time frame: 1,5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01642680, which also lists 2 linked publications.
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 6 May 2024.