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Healthly VolunteersCOMPASSNCT07706465

A Two-Way Path to Health: Environmental Influences on Skeletal Muscle Endocrine Function

A study testing Experimental: IWT- Interval Walking Training, Exercise training II and Walking in people with Healthly Volunteers and Oncologic Disease, run by Poznan University of Physical Education.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

Given the well-established anti-inflammatory and health-promoting effects of physical activity as a non-pharmacological intervention, an important question remains whether different types of exercise differ in their ability to reduce the body burden of per- and polyfluoroalkyl substances (PFAS) and whether PFAS… Read more about this study

Who is it for?
Ages 35 to 75 years, women onlyHealthy volunteers can take part
Conditions the study is for
Healthly Volunteers, Oncologic Disease
What is being tested?
Experimental: IWT- Interval Walking Training, Exercise training II and Walking
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
No sites listed yet
Study dates
20 Aug 2026to 30 Jan 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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 35 to 75 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women,
  • aged 35-75 years
  • qualified by a physician for participation in the study and with no contraindications to the training intervention (e.g., heart failure, asthma, chronic obstructive pulmonary disease [COPD], or arthritis)
  • Women ,
  • aged 35-75 years,
  • Diagnosed with invasive breast cancer, Stage I-III disease according to the TNM classification,
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  • Estrogen receptor-positive (ER+) breast cancer, defined as expression in at least 10% of tumor cell nuclei,
  • Adjuvant hormone therapy with an aromatase inhibitor for at least 6 months,
  • BMI between 18.5 and 32 kg/m².
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
  • No chronic diseases limiting the possibility of oncological treatment.
  • No contraindications to daily physical activity.
  • Willingness to maintain a daily step count of 8,000 steps.

Who cannot join

  • history of cardiovascular disease,
  • previous hospitalization for cardiovascular conditions,
  • ongoing cardiovascular treatment, or recent cardiovascular symptoms,
  • advanced osteoporosis
  • Stage IV invasive breast cancer according to the TNM classification.
  • ECOG performance status ≥2.
Show all 14Show fewer
  • Unstable ischemic heart disease.
  • Cardiac arrhythmias.
  • Advanced degenerative joint disease.
  • Rheumatic disorders (including rheumatoid arthritis, osteoarthritis, or fibromyalgia).
  • Progression of chronic diseases.
  • Pregnancy.
  • BMI <18.5 or >32 kg/m².
  • Uncontrolled hypothyroidism or hyperthyroidism.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Ewa Ziemann, Professor contact

0048606330944

ewa.ziemann@awf.poznan.pl

About this study

Official title: A Two-Way Path to Health: Exploring Whether Environmental Factors Influence Skeletal Muscle Endocrine Function and Modulate Physical Activity-Induced Adaptations in Middle-Aged Women

Given the well-established anti-inflammatory and health-promoting effects of physical activity as a non-pharmacological intervention, an important question remains whether different types of exercise differ in their ability to reduce the body burden of per- and polyfluoroalkyl substances (PFAS) and whether PFAS exposure modifies exercise-induced adaptive responses. The investigators hypothesize that the coexistence of physical inactivity, overweight/obesity, reduced muscle mass, and consequently lower concentrations of myokines/exerkines contributes to impaired cardiovascular function, reduced exercise capacity, and a greater PFAS body burden. Collectively, these factors may adversely affect work ability, reduce occupational participation, and discourage continued employment among middle-aged women. In the context of unfavorable demographic trends, such consequences may represent a significant economic burden for society.

The primary objective of this project is to determine whether baseline PFAS concentrations are associated with the health status of women entering the study and to characterize circulating profiles of myokines/exerkines and arginine metabolites. A secondary objective is to compare the effects of different exercise programs on PFAS concentrations and their potential elimination from the body. In addition, we will investigate whether a history of cancer treatment, despite increasingly favorable clinical outcomes, is associated with long-term alterations in skeletal muscle endocrine function, myokine and exerkine release, and PFAS body burden.

Read more

The study will include perimenopausal women. Participants will be allocated to one of two supervised exercise programs: high-intensity circuit training (HICT) or interval walking training (IWT). Both interventions will last six months and will be performed two times per week (with possible additional unit performed at home). This period will be followed by six months of unsupervised maintenance training. Two additional groups will be included: a control group maintaining their usual lifestyle and a group of women who have completed cancer treatment. Participants in the oncology group will be instructed to maintain a daily physical activity level of approximately 7,000-10,000 steps.

Assessments will be performed at baseline, immediately after the intervention, and six months after its completion. Circulating concentrations of selected myokines, exerkines, arginine metabolites, and 18 PFAS compounds will be measured in blood, while PFAS concentrations will also be determined in urine samples. Cardiorespiratory fitness, body composition assessed by dual-energy X-ray absorptiometry (DXA), dietary habits, quality of life, and health literacy will also be evaluated.

Read the detailed description

To date, PFAS exposure has been linked to disturbances in lipid and cholesterol metabolism, oxidative stress, and endocrine dysfunction, including alterations in thyroid and steroid hormone regulation. However, there is a lack of data regarding the effects of PFAS-chemicals widely used in numerous industrial and consumer applications and ubiquitous in the environment-on exercise-induced adaptive responses.

Over the past two decades, research has demonstrated the critical role of specific proteins released by skeletal muscle (myokines) and other organs, including the brain, heart, and liver (collectively referred to as exerkines), in mediating physiological adaptations to exercise. The extent to which PFAS influence these signaling pathways remains unknown. The limited evidence available from animal studies suggests that PFAS may adversely affect the metabolic potential of skeletal muscle. Given the widespread presence of PFAS in the environment and their accumulation within the human body, the research proposed in this project has substantial societal and public health relevance.

Scientific evidence indicates that PFAS bioaccumulate in critical organs, including the liver, kidneys, and placenta, potentially affecting fetal development and long-term metabolic health. PFAS have been detected in multiple tissues and are characterized by prolonged biological half-lives ranging from several months to as long as six years. PFAS are known to disrupt lipid metabolism and vascular function, potentially contributing to the development of metabolic syndrome and type 2 diabetes mellitus. They have also been identified as compounds capable of altering lipid storage and energy metabolism, thereby promoting obesity. Available evidence further suggests that PFAS exposure is associated with an increased risk of cardiovascular diseases, including hypertension, atherosclerosis, and heart failure. These adverse health effects may be amplified in urban populations exposed to high levels of environmental pollution and characterized by sedentary lifestyles with limited physical activity. Consequently, both elevated PFAS exposure and physical inactivity may independently and synergistically contribute to the burden of chronic diseases.

Given the well-established anti-inflammatory effects of physical activity and its recognized role as a non-pharmacological strategy for health promotion and rehabilitation, it is essential to determine whether PFAS accumulation limits exercise-induced adaptations and impairs the endocrine function of skeletal muscle. Recent studies suggest that environmental pollutants may influence exercise responses and PFAS clearance dynamics. However, the mechanisms regulating exercise-induced PFAS redistribution remain largely unknown. A limited number of animal studies have demonstrated potential adverse effects of PFAS on skeletal muscle cells and their regenerative capacity, whereas comparable human studies are lacking.

In recent years, myokines and exerkines have emerged as key mediators of health-promoting adaptations to exercise. Nevertheless, little is known about how persistent environmental pollutants modulate their secretion and biological activity. In our previous studies, we observed substantial interindividual variability in exercise-induced responses of several key myokines and exerkines, including interleukin-6 (IL-6), soluble IL-6 receptor, gp130, irisin, decorin, follistatin, myostatin, IL-15, N-lactoyl-phenylalanine (Lac-Phe), and brain-derived neurotrophic factor (BDNF). Given the ubiquitous presence of PFAS and their potential impact on public health, further research is urgently needed to elucidate the mechanisms of PFAS bioaccumulation, elimination, and potential mitigation strategies.

According to national cancer statistics from 2022, breast cancer accounted for 23.6% of all female cancer cases in Poland (N = 21,554; ASW = 60.6; ESP2013 = 103.9). In the Greater Poland region, the corresponding figure was 25.5% (N = 2,221; ASW = 71.8; ESP2013 = 122.2). Despite substantial improvements in oncological treatment outcomes, women diagnosed with estrogen receptor-positive (ER+) breast cancer, which represents the majority of cases, typically receive adjuvant endocrine therapy with aromatase inhibitors (AIs) for a period of 5-10 years. Although such treatment significantly improves survival, it is associated with numerous adverse effects, leading 20-50% of patients to discontinue therapy prematurely. These treatment-related consequences often result in hypokinesia and fear of physical activity, thereby promoting the development of sarcopenia and osteopenia. Disturbances in glucose homeostasis, overweight and obesity, and impaired cardiovascular and respiratory function are also frequently observed. Recent epidemiological findings published in 2025, based on data from the UK Biobank (n = 315,457 participants, including 48.1% women; mean age 56.1 ± 8.2 years) and more than 10 years of follow-up, demonstrated that failure to meet World Health Organization (WHO) recommendations for waist circumference was associated with an 11% increase in overall cancer risk, whereas failure to meet WHO physical activity recommendations was associated with a 5% increase in cancer risk. From a preventive medicine perspective, it is difficult to establish a hierarchy among the numerous factors influencing women's health. Importantly, not only body composition but also optimal cardiovascular and cardiac function appear to be central determinants of health outcomes. It may be hypothesized that hypokinesia, overweight, obesity, low muscle and bone mass, reduced concentrations of myokines, hormonal alterations, and cancer collectively impair cardiovascular function. Although numerous studies have demonstrated the beneficial effects of physical activity on health, a key unanswered question is whether physical activity influences PFAS distribution within the human body and facilitates their elimination. While considerable attention has been devoted to chronic PFAS exposure and the long-term consequences of accumulation, relatively little is known about the effects of acute physiological stressors, such as high-intensity exercise, on PFAS distribution within the circulation. Therefore, the development of evidence-based exercise programs and the identification of previously unrecognized factors regulating adaptive responses are of considerable importance for women's health. Collectively, the available evidence strongly supports the need for further research and preventive actions in this area.

The project will address the following research questions:

  1. To determine and compare baseline concentrations of PFAS and selected myokines/exerkines (proteins released in response to skeletal muscle contraction) in women entering the study. Which factors determine cardiorespiratory fitness, cardiovascular function, and the capacity for PFAS redistribution and elimination from the body?
  2. To determine changes in circulating concentrations of selected myokines/exerkines in relation to PFAS concentrations following two supervised 6-month exercise interventions. Does exercise intensity and regularity influence PFAS redistribution and elimination, thereby improving women's health outcomes? Which exercise program is more effective in promoting PFAS elimination from the body?
  3. To determine the role of physical activity in PFAS redistribution and elimination. The findings may provide an additional rationale for promoting long-term engagement in regular physical activity among women. For this reason, participants will undergo a further assessment six months after completion of the intervention. PFAS concentrations will be assessed in both blood and urine and correlated with changes in exercise-induced proteins.
  4. To develop and validate a method for PFAS determination in urine samples in order to characterize patterns of PFAS redistribution and elimination.

To determine whether previous cancer treatment combined with aromatase inhibitor therapy affects the endocrine potential of skeletal muscle in physically active women, and whether PFAS burden attenuates the regenerative capacity of skeletal muscle.

Milestone I The results obtained during the first stage of the project will allow to determine how PFAS concentrations, lifestyle factors, health literacy, dietary habits, and physical activity influence the endocrine function of skeletal muscle, circulating concentrations of myokines/exerkines, arginine metabolites, and overall health status in participating women.

The collected data and subsequent analyses will provide insights into the concept of the "endocrine potential" of skeletal muscle. Traditionally, body composition and health status have often been assessed using body mass index (BMI) alone. However, increasing evidence highlights the importance of skeletal muscle not only as a locomotor and stabilizing tissue but also as a key endocrine organ.

The application of advanced methods for assessing circulating myokines/exerkines and PFAS concentrations will enable a more precise characterization of skeletal muscle function and the role of health-related behaviors. The interdisciplinary nature of the proposed research, focusing on the relationship between PFAS exposure and skeletal muscle endocrine function-an area not previously investigated-constitutes the innovative aspect of the project.

Milestone II The objective of this stage is to determine how previous cancer treatment in women who have undergone breast cancer therapy affects the endocrine potential of skeletal muscle. Thee investigators will also establish whether cancer treatment is associated with increased PFAS concentrations as a consequence of impaired skeletal muscle endocrine function.

Milestone III To identify the most effective form of physical activity for promoting PFAS redistribution and elimination from the body. Following the six-month intervention period, implementation of the exercise programs, and completion of the planned biochemical analyses, it will be possible to determine which training modality provides greater health benefits.

The investigators hypothesize that resistance-type exercise will be more effective in facilitating PFAS elimination due to the greater involvement of skeletal muscle mass and consequently how that both exercise interventions will improve cardiovascular function and cardiorespiratory fitness.

Milestone IV To evaluate whether maintaining a daily physical activity level of approximately 8,000 steps is sufficient to promote PFAS elimination in women who have completed cancer treatment and are receiving aromatase inhibitor therapy.

In addition, the impact of PFAS and myokines/exerkines concentrations on the immune potential of CD8⁺ T cells and CD3⁺ T cells will be assess.

Milestone V To develop evidence-based recommendations regarding PFAS redistribution and elimination in women, with particular emphasis on breast cancer survivors.

The final outcome of this stage will be the determination of how the implemented exercise interventions improve cardiovascular function through alterations in arginine metabolite profiles, improvements in exercise-test parameters, and modulation of the endocrine function of skeletal muscle.

Milestone VI Dissemination of the developed recommendations in the form of practical guidelines entitled: "Myths and Facts of the Two-Way Path to Health: Muscles and the Environment."

Being tested
Experimental: IWT- Interval Walking Training, Exercise training II, Walking
Keywords
PFAS, skeletal muscle endocrine function, myokines and exerkines, physical activity, perimenopausal women, exercise adaptation, women's health
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Experimental: IWT- Interval Walking TrainingOther

    Interval Walking Training will consist of five repetitions of alternating 3-minute intervals of fast and slow walking, resulting in a total exercise duration of 30 minutes per session. The training period will last 6 months, two training session/a week.

  • Exercise training IIOther

    HICT training will consist of ten exercises: jumping jacks, push-ups, abdominal crunches, squats, planks, triceps dips using a chair, high knees (running in place), lunges, push-ups with rotation, and side planks. Each exercise will be performed for 30 seconds, followed by a 10-second transition period. A 2-minute rest period will be provided between sets. Training period will last 6 monts /a two training session a week

  • WalkingOther

    Walking training is addressed to breast cancer patients who have already finished onco-treatment. Participants will be instructed to maintain a daily step count of 7,000-10,000 steps throughout the study period.

Study groups in NCT07706465
Study groupRoleWhat they receive
Control GroupNo interventionThe healthy, control group (n = 70) will be included in the study. Assessments will be conducted at three time points. Participants will be instructed not to modify their usual lifestyle throughout the study period.
IWT- Interval Walking TrainingExperimentalThe healthy IWT group- a six-month supervised exercise intervention conducted under the supervision of a qualified exercise trainer.
Receives: Other: Experimental: IWT- Interval Walking Training
HICT-High Intensity Circuit TrainingExperimentalThe healthy HICT group - a six-month supervised exercise intervention conducted under the supervision of a qualified exercise trainer.
Receives: Other: Exercise training II
Onco-female groupExperimentalA group of female cancer survivors will be included in the study. Participants will be encouraged to achieve a moderate level of physical activity equivalent to approximately 8,000 steps per day. Physical activity will be continuously monitored using wearable step-counting devices, and compliance with the prescribed activity will be regularly supervised by a physiotherapist.
Receives: Other: Walking

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Cell Counts (×10⁹/L)

    Blood Cell Counts (×10⁹/L): White Blood Cell Count (WBC), Platelet Count (PLT), Neutrophil Count (NEUT), Lymphocyte Count (LYMPH), Monocyte Count (MONO), Eosinophil Count (EOS), and Basophil Count (BASO) will be determined using standard analytical method.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  2. Leukocyte Differential Percentages (%)

    The percentages (%) of neutrophils (NEUT), lymphocytes (LYMPH), monocytes (MONO), eosinophils (EOS), and basophils (BASO) will be determined as part of the complete blood count with differential.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  3. Red Blood Cell Count (RBC)

    Red Blood Cell Count (×10¹²/L)

    Measured: At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  4. Blood Concentrations

    Blood Concentrations (g/dL): Hemoglobin Concentration (HGB) and Mean Corpuscular Hemoglobin Concentration (MCHC).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  5. Hematological Volume Indices

    Hematological Volume Indices (fL): Mean Corpuscular Volume (MCV) and Mean Platelet Volume (MPV).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  6. Mean Hemoglobin Content

    Mean Hemoglobin Content (pg): Mean Corpuscular Hemoglobin (MCH).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  7. Hematological Percentage Indices

    Hematological Percentage Indices (%): Hematocrit (HCT), Red Cell Distribution Width (RDW), Platelet Distribution Width (PDW), Plateletcrit (PCT), and Platelet Large Cell Ratio (P-LCR) .

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  8. Irisin, BDNF, IL-6, gp130, sIL-6R, IL-15, IL-15Rα, decorin, myostatin, follistatin, MuRF1, and Lac-Phe

    Selected myokines and exerkines, including irisin, brain-derived neurotrophic factor (BDNF), interleukin-6 (IL-6), gp130, soluble IL-6 receptor (sIL-6R), IL-15, IL-15Rα, decorin, insulin, myostatin, follistatin, muscle RING-finger protein-1 (MuRF1; an E3 ubiquitin ligase commonly used as a marker of muscle atrophy), and N-lactoyl-phenylalanine (Lac-Phe), will be quantified using enzyme-linked immunosorbent assays (ELISA) with commercially available high-sensitivity kits from reputable manufacturers. Blood serum or plasma will be used (as per requirements). All proteins will be expressed in ng/ml.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  9. T-Lymphocyte Subpopulation Percentages (%)

    The percentage (%) of CD4⁺CCR7⁺, CD8⁺CCR7⁺, CD4⁺CD28⁺, and CD8⁺CD28⁺ cell populations will be determined by flow cytometry.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  10. L-arginine, L-citrulline, L-ornithine, ADMA, SDMA

    Arginine metabolites will be quantified in serum using the isotope dilution liquid chromatography-tandem mass spectrometry (ID-LC-MS/MS) technique, which has been successfully applied in our previous studies. All metabolites will be expressed in ng/ml.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  11. Per- and Polyfluoroalkyl Substances (PFAS)

    PFAS concentrations in plasma and urine samples will be quantified using ultra-high-performance liquid chromatography coupled with tandem mass spectrometry (UHPLC-MS/MS). A panel of 18 PFAS, among the most commonly detected and widely used, has been selected for analysis. All PFAS will be expressed in ng/ml.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  12. Inflammatory ratio

    Inflammatory hematological ratios Indicators of inflammation (Neutrophil to Lymphocyte ratio, Monocyte to Lymphocyte ratio, Platelet to Lymphocyte ratio) will be calculated made based on hematological medical records.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  13. HOMA-%B, HOMA-%S,

    Indices of insulin resistance and insulin sensitivity, including pancreatic β-cell function (HOMA-%B), insulin sensitivity (HOMA-%S) will be calculated.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  14. Blood glucose

    Blood glucose concentration (mg/dl) will be measured using standard analytical methods.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  15. Glycated hemoglobin

    Glycated hemoglobin (HbA1c) (%) will be measured using standard analytical methods.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  16. Insulin

    Serum insulin ( µIU/ml ) concentration will be measured using a high-sensitivity immunoenzymatically assay according to the manufacturer's instructions.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  17. Insulin resistance

    Insulin resistance (HOMA-IR) will be calculated.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

Secondary outcomes (15)
  1. Oxygen uptake at rest, at anaerobic threshold and maximal intensity

    Oxygen uptake will be measured and expressed in absolute VO₂ L·min-¹ values

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  2. Oxygen uptake at rest, at anaerobic threshold and maximal intensity

    Description: Oxygen uptake will be measured and expressed in relative VO₂ mL·min-¹ kg-¹ values.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  3. Heart Rate

    Resting and maximal Heart Rate (beats/min). This outcome will be measured during the Ramp test.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  4. Body Height

    Body Height (m) is measured using Digital stadiometer (Seca 285, SECA, Hamburg, Germany).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  5. Total body mass, Total fat mass, Total lean mass, Android fat mass, Gynoid fat mass, Intra-Cellular Water, Extra-Cellular Water, Total Body Water, Bone Mass component

    Body compositions (kg) including body weight, fat tissue, muscle mass, bone density will be tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  6. Bone Mineral Density

    Bone Mineral Density (g/cm2). Indicator of bone mineral density will be tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  7. Percent body fat

    Percentage of fat mass (%) will be assessed using dual X-ray absorptiometry (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA, and enCORE v. 16 SP1 software). It will be expressed as a percentage of total body mass.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  8. Visceral Adipose Tissue

    Visceral Adipose Tissue (cm3). It will be tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  9. Relative Skeletal Muscle Mass Index

    Relative Skeletal Muscle Mass Index (RSMI) (kg/m2). Indicators of body composition will be tested by the dual X-ray absorptiometry method (DXA, Lunar Prodigy; General Electric Lunar Healthcare Technologies, Madison, USA and enCORE v. 16 SP1 software).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  10. Handgrip strength - HGS

    HGS will be measured using a calibrated handheld dynamometer. Participants will perform maximal voluntary contractions with the dominant hand, and the highest value obtained from three attempts will be recorded for analysis.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  11. Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective)

    Quality of life - Functional scores (body image, sexual functioning, sexual enjoyment, future perspective) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module). On the scale minimum value is 1, maximum value is 4. A high score represents a high /healthy level of functioning (better outcome).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  12. Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss)

    Quality of life - Symptom scores (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss) assessment with EORTC QLQ-BR23 Questionnaire (Breast cancer module).On the scale minimum value is 1, maximum value is 4. A high score for a symptom scale represents a high level of symptomatology / problems (worse outcome).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  13. Level of Physical Activity

    A self-report scale that measures physical activity. The IPAQ comprises 27 items that assess time spent engaging in various levels of physical activity and includes sitting time.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  14. Health literacy

    Health literacy will be evaluated using a validated 47-item questionnaire, designed to assess an individual's ability to access health information, understand such information, evaluate its reliability, and apply it in everyday decision-making.

    The questionnaire covers three key domains: healthcare (HC-HL), disease prevention (DP-HL), and health promotion (HP-HL).

    Mean scores are calculated separately for each domain. Scores range from 1 to 4, and from 1 to 5. Higher scores indicate greater health literacy strengths within the respective domain. No overall total HLQ score will be calculated.

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

  15. Dietary habits

    Dietary intake will be evaluated based on a 3-day food record, including two weekdays and one non-working day (weekend day).

    Measured: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jul 2026
  2. Study start20 Aug 2026 (estimated)
  3. Primary completion30 Aug 2028 (estimated)
  4. Study completion30 Jan 2029 (estimated)

Resources

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
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
The study will recruit 170 women into the training groups: IWT training, n=85, HICT: n=85 Control group (n=70) Onco female group- patients who have undergone cancer treatment n=60
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07706465
Sponsor's protocol ID
NdRS/SP/0034/2025/01
Other IDs
NdRS/SP/0034/2025/01
Acronym
COMPASS
Status last verified
Jun 2026
First submitted
16 Jun 2026
Last updated
15 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Experimental: IWT- Interval Walking Training, Exercise training II and Walking in people with Healthly Volunteers and Oncologic Disease, run by Poznan University of Physical Education.

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 13 inclusion and 14 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: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marzena Szerment, MA (0048618355061, marzena.szerment@awf.poznan.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Cell Counts (×10⁹/L) (time frame: "At day 1" "after 6 months on day 1" "On average, in 1 year from day 1"). The study lists 17 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 15 Jul 2026.

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