Stress, PsychologicalNCT07175974
Feldenkrais Method and Stress-Related Responses in Adult Women
A study testing Feldenkrais Method - Awareness Through Movement (ATM) in people with Stress, Psychological and Autonomic Nervous System, run by University of Palermo at 1 site in Italy.
Trial summary
This pilot study aimed to explore whether the Feldenkrais Method, a gentle movement and awareness practice, could help reduce stress and improve well-being in sedentary adult women. Twenty-four women aged 26-59 years were recruited. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Autonomic Nervous System, Hydration
- What is being tested?
- Feldenkrais Method - Awareness Through Movement (ATM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2023to 1 Jul 2023
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Female (age ≥18 years)
- Healthy (no musculoskeletal disorders or other conditions limiting participation in the Feldenkrais Method protocol)
- Sedentary lifestyle (<150 min/week of moderate-intensity physical activity or <75 min/week of vigorous-intensity activity)
Who cannot join
- Male
- Presence of acute or chronic medical conditions
- Current pregnancy
Trial locations and contacts
1 site in 1 country.
Italy1 site
Sport and Exercise Sciences Research Unit, Department of Psychology, Educational Science and Human Movement, University of Palermo. Centro Forte Feldenkrais di Caterina Forte
Palermo, Palermo, 90144
About this study
Official title: Effects of a Feldenkrais Method-Based Protocol on Body Fluid Balance and Stress-Related Responses in Healthy Adult Women: A Pilot Study
This pilot study aimed to explore whether the Feldenkrais Method, a gentle movement and awareness practice, could help reduce stress and improve well-being in sedentary adult women. Twenty-four women aged 26-59 years were recruited. Participants were assigned to either an intervention group, which completed eight consecutive daily Feldenkrais sessions (90 minutes each), or to a control group.
Before and after the program, all participants were assessed for: resting heart rate (HR), averaged over 5 minutes, and heart rate variability (HRV) to measure nervous system balance; total body water (TBW) and extracellular water (ECW), and a marker of stress response, the Hypothalamic-Pituitary-Adrenal (HPA) axis index, using bioelectrical impedance analysis (BIA); weight and height; and questionnaires to evaluate psychological well-being and self-compassion.
Read the detailed description
Background and Rationale: The Feldenkrais Method® (FM) is a mind-body approach that uses gentle, slow, and mindful movements to enhance self-awareness, motor control, and movement efficiency. Similar mind-body practices such as Yoga and Tai Chi have been shown to improve autonomic regulation, reduce stress-related biomarkers, and enhance psychological well-being. Chronic stress, particularly in sedentary individuals, can negatively affect the autonomic nervous system (ANS), hypothalamic-pituitary-adrenal (HPA) axis, and cardiovascular health. Despite the growing popularity of FM, evidence regarding its effects on autonomic balance and stress adaptation remains limited.
Study Purpose and Hypothesis: This pilot study aimed to explore whether a short FM-based protocol could influence physiological and psychological responses to stress in healthy adult women. It was hypothesized that participation in an 8-day FM program would improve autonomic regulation, body fluid balance, and psychological well-being.
Study Design: A pilot study was conducted with 24 healthy sedentary women. Participants were assigned to either an intervention group (IG) or a control group (CG) based on their interest and availability to attend all FM sessions. Due to the intensive nature of the intervention and practical constraints, randomization was not performed. All participants provided written informed consent, and the study was approved by the Bioethics Committee of the University of Palermo (Approval No. 129/2023). Assessments were conducted pre- and post-intervention at the "Studio Forte" and the "Functional Assessment Laboratory" of Palermo University between April and July 2023.
Participant Selection and Sedentary Criteria: Inclusion criteria required participants to be healthy, adult sedentary women (≥18 years). Sedentariness was defined according to World Health Organization guidelines: less than 150 minutes per week of moderate-intensity activity, less than 75 minutes per week of vigorous activity, or an equivalent combination. Data were collected using a self-administered questionnaire covering demographic information, education level, occupation, weekly minutes of physical activity, and self-reported medical history.
Intervention: The IG performed eight consecutive Awareness Through Movement (ATM) lessons, each lasting 90 minutes, focusing on upper limb functionality and integration with trunk movements. The CG did not participate in any structured activity during the same period.
Outcome Measures: Physiological outcomes included resting heart rate (HR), averaged over 5 minutes, heart rate variability (HRV) assessed via Polar H10 sensor, total body water (TBW), extracellular water (ECW), and HPA axis index measured through bioelectrical impedance analysis (BIA). Body weight and height were measured by the study operator using a standard digital scale and stadiometer, respectively.
HRV metrics encompassed time-domain (SDNN, RMSSD) and frequency-domain (VLF, LF, HF, LF/HF ratio) parameters. TBW and ECW reflected body fluid distribution, while the HPA axis index provided an indirect measure of neuroendocrine adaptation to stress. The Psychological Well-Being Scale (PWBS) and the Self-Compassion Scale (SCS) were used to assess psychological well-being and self-compassion, respectively.
- Being tested
- Feldenkrais Method - Awareness Through Movement (ATM)
- Keywords
- Feldenkrais Method, Mind-Body Intervention, Stress Adaptation, Body Fluid Balance, Psychological Well-Being, Self-Compassion
- Medical subject headings
- Stress, Psychological, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feldenkrais Method - Awareness Through Movement (ATM)Behavioural
Participants attended eight consecutive sessions of the Feldenkrais Method, each lasting 90 minutes, over 8 days (total 12 hours). Sessions focused on enhancing upper limb functionality, trunk integration, posture, coordination, body awareness, and somatic regulation through slow, mindful, guided movements.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group - Feldenkrais Method | Experimental | Participants attended eight consecutive "Awareness Through Movement" (ATM) sessions of the Feldenkrais Method, each lasting 90 minutes, over 8 days (total 12 hours). The protocol focused on improving upper limb functionality, integration with trunk movement, posture, coordination, and body awareness. Receives: Behavioral: Feldenkrais Method - Awareness Through Movement (ATM) |
| Control Group - No Intervention | No intervention | Participants did not receive any intervention or structured physical activity during the 8-day study period. They continued their usual daily routines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Body Water (TBW)
Total body water measured via bioelectrical impedance analysis (BIA), in liters (L).
Measured: Baseline and post-intervention (8 days)
Extracellular Water (ECW)
Extracellular water measured via bioelectrical impedance analysis (BIA), in liters (L).
Measured: Baseline and post-intervention (8 days)
Hypothalamic-Pituitary-Adrenal (HPA) Axis Index
Hypothalamic-pituitary-adrenal (HPA) axis index measured via bioelectrical impedance analysis (BIA), expressed as phase angle (PA°).
Measured: Baseline and post-intervention (8 days)
Resting Heart Rate (HR)
Resting heart rate measured using a Polar H10 chest strap, calculated as the average heart rate over a 5-minute period, in beats per minute (bpm).
Measured: Baseline and post-intervention (8 days)
Standard Deviation of NN intervals (SDNN)
SDNN measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds (ms).
Measured: Baseline and post-intervention (8 days)
Root Mean Square of Successive Differences (RMSSD)
RMSSD measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds (ms).
Measured: Baseline and post-intervention (8 days)
Very Low Frequency (VLF) Power
VLF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
Measured: Baseline and post-intervention (8 days)
Low Frequency (LF) Power
LF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
Measured: Baseline and post-intervention (8 days)
High Frequency (HF) Power
HF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
Measured: Baseline and post-intervention (8 days)
LF/HF Ratio
LF/HF ratio calculated from heart rate variability using a Polar H10 chest strap and Kubios HRV software (unitless).
Measured: Baseline and post-intervention (8 days)
Secondary outcomes (2)
Psychological Well-Being Scale (PWBS)
Total score on the Psychological Well-Being Scale, in units on a scale.
Measured: Baseline and post-intervention (8 days)
Self-Compassion Scale (SCS)
Total score on the Self-Compassion Scale, in units on a scale.
Measured: Baseline and post-intervention (8 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Apr 2023
- Primary completion1 May 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants were assigned to either the Feldenkrais Method intervention group or the control group based on availability and willingness to attend all sessions. Outcomes were assessed pre- and post-intervention for both groups.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Palermo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marianna Bellafiore, University of Palermo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175974
- Sponsor's protocol ID
- FM-2023-PILOT
- Status last verified
- Sep 2025
- First submitted
- 4 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Agnese M, Cottone R, Forte C, Scardina A, Navarra GA, Buttitta D, Tabacchi G, Bellafiore M. Effects of a Feldenkrais method-based protocol on body fluid balance and stress-related measures in healthy adult women: A pilot study. J Bodyw Mov Ther. 2025 Dec;45:812-818. doi: 10.1016/j.jbmt.2025.10.012. Epub 2025 Oct 8.
PubMed 41316654
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Feldenkrais Method-Based Protocol on Body Fluid Balance and Stress-Related Responses in Healthy Adult Women: A Pilot Study
- ClinicalTrials.gov ID
- NCT07175974
- Acronym / sponsor ID
- FM-2023-PILOT
- Keywords
- Feldenkrais Method, Mind-Body Intervention, Stress Adaptation, Body Fluid Balance, Psychological Well-Being, Self-Compassion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of PalermoUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 16 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study aimed to explore whether the Feldenkrais Method, a gentle movement and awareness practice, could help reduce stress and improve well-being in sedentary adult women. Twenty-four women aged 26-59 years were recruited. Participants were assigned to either an intervention group, which completed eight consecutive daily Feldenkrais sessions (90 minutes each), or to a control group.
Before and after the program, all participants were assessed for: resting heart rate (HR), averaged over 5 minutes, and heart rate variability (HRV) to measure nervous system balance; total body water (TBW) and extracellular water (ECW), and a marker of stress response, the Hypothalamic-Pituitary-Adrenal (HPA) axis index, using bioelectrical impedance analysis (BIA); weight and height; and questionnaires to evaluate psychological well-being and self-compassion.
Detailed description
Background and Rationale: The Feldenkrais Method® (FM) is a mind-body approach that uses gentle, slow, and mindful movements to enhance self-awareness, motor control, and movement efficiency. Similar mind-body practices such as Yoga and Tai Chi have been shown to improve autonomic regulation, reduce stress-related biomarkers, and enhance psychological well-being. Chronic stress, particularly in sedentary individuals, can negatively affect the autonomic nervous system (ANS), hypothalamic-pituitary-adrenal (HPA) axis, and cardiovascular health. Despite the growing popularity of FM, evidence regarding its effects on autonomic balance and stress adaptation remains limited.
Study Purpose and Hypothesis: This pilot study aimed to explore whether a short FM-based protocol could influence physiological and psychological responses to stress in healthy adult women. It was hypothesized that participation in an 8-day FM program would improve autonomic regulation, body fluid balance, and psychological well-being.
Study Design: A pilot study was conducted with 24 healthy sedentary women. Participants were assigned to either an intervention group (IG) or a control group (CG) based on their interest and availability to attend all FM sessions. Due to the intensive nature of the intervention and practical constraints, randomization was not performed. All participants provided written informed consent, and the study was approved by the Bioethics Committee of the University of Palermo (Approval No. 129/2023). Assessments were conducted pre- and post-intervention at the "Studio Forte" and the "Functional Assessment Laboratory" of Palermo University between April and July 2023.
Participant Selection and Sedentary Criteria: Inclusion criteria required participants to be healthy, adult sedentary women (≥18 years). Sedentariness was defined according to World Health Organization guidelines: less than 150 minutes per week of moderate-intensity activity, less than 75 minutes per week of vigorous activity, or an equivalent combination. Data were collected using a self-administered questionnaire covering demographic information, education level, occupation, weekly minutes of physical activity, and self-reported medical history.
Intervention: The IG performed eight consecutive Awareness Through Movement (ATM) lessons, each lasting 90 minutes, focusing on upper limb functionality and integration with trunk movements. The CG did not participate in any structured activity during the same period.
Outcome Measures: Physiological outcomes included resting heart rate (HR), averaged over 5 minutes, heart rate variability (HRV) assessed via Polar H10 sensor, total body water (TBW), extracellular water (ECW), and HPA axis index measured through bioelectrical impedance analysis (BIA). Body weight and height were measured by the study operator using a standard digital scale and stadiometer, respectively.
HRV metrics encompassed time-domain (SDNN, RMSSD) and frequency-domain (VLF, LF, HF, LF/HF ratio) parameters. TBW and ECW reflected body fluid distribution, while the HPA axis index provided an indirect measure of neuroendocrine adaptation to stress. The Psychological Well-Being Scale (PWBS) and the Self-Compassion Scale (SCS) were used to assess psychological well-being and self-compassion, respectively.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were assigned to either the Feldenkrais Method intervention group or the control group based on availability and willingness to attend all sessions. Outcomes were assessed pre- and post-intervention for both groups.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group - Feldenkrais Method | Experimental | Behavioral: Feldenkrais Method - Awareness Through Movement (ATM)Participants attended eight consecutive "Awareness Through Movement" (ATM) sessions of the Feldenkrais Method, each lasting 90 minutes, over 8 days (total 12 hours). The protocol focused on improving upper limb functionality, integration with trunk movement, posture, coordination, and body awareness. |
| Control Group - No Intervention | No intervention | –Participants did not receive any intervention or structured physical activity during the 8-day study period. They continued their usual daily routines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female (age ≥18 years)
- Healthy (no musculoskeletal disorders or other conditions limiting participation in the Feldenkrais Method protocol)
- Sedentary lifestyle (<150 min/week of moderate-intensity physical activity or <75 min/week of vigorous-intensity activity)
Key exclusion criteria (3 listed)
- Male
- Presence of acute or chronic medical conditions
- Current pregnancy
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 |
|---|---|---|
| Feldenkrais Method - Awareness Through Movement (ATM)Participants attended eight consecutive sessions of the Feldenkrais Method, each lasting 90 minutes, over 8 days (total 12 hours). Sessions focused on enhancing upper limb functionality, trunk integration, posture, coordination, body awareness, and somatic regulation through slow, mindful, guided movements. | Behavioural | Intervention Group - Feldenkrais Method |
Primary outcome
Total Body Water (TBW)
Time frame: Baseline and post-intervention (8 days)
Total body water measured via bioelectrical impedance analysis (BIA), in liters (L).
Extracellular Water (ECW)
Time frame: Baseline and post-intervention (8 days)
Extracellular water measured via bioelectrical impedance analysis (BIA), in liters (L).
Hypothalamic-Pituitary-Adrenal (HPA) Axis Index
Time frame: Baseline and post-intervention (8 days)
Hypothalamic-pituitary-adrenal (HPA) axis index measured via bioelectrical impedance analysis (BIA), expressed as phase angle (PA°).
Resting Heart Rate (HR)
Time frame: Baseline and post-intervention (8 days)
Resting heart rate measured using a Polar H10 chest strap, calculated as the average heart rate over a 5-minute period, in beats per minute (bpm).
Standard Deviation of NN intervals (SDNN)
Time frame: Baseline and post-intervention (8 days)
SDNN measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds (ms).
Root Mean Square of Successive Differences (RMSSD)
Time frame: Baseline and post-intervention (8 days)
RMSSD measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds (ms).
Very Low Frequency (VLF) Power
Time frame: Baseline and post-intervention (8 days)
VLF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
Low Frequency (LF) Power
Time frame: Baseline and post-intervention (8 days)
LF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
High Frequency (HF) Power
Time frame: Baseline and post-intervention (8 days)
HF power measured from heart rate variability using a Polar H10 chest strap and Kubios HRV software, in milliseconds squared (ms²).
LF/HF Ratio
Time frame: Baseline and post-intervention (8 days)
LF/HF ratio calculated from heart rate variability using a Polar H10 chest strap and Kubios HRV software (unitless).
2 secondary outcomes
Psychological Well-Being Scale (PWBS)
Time frame: Baseline and post-intervention (8 days)
Self-Compassion Scale (SCS)
Time frame: Baseline and post-intervention (8 days)
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 16 Sep 2025.
- Derived from this study: PubMed 41316654Agnese M, Cottone R, Forte C, Scardina A, Navarra GA, Buttitta D, Tabacchi G, Bellafiore M. Effects of a Feldenkrais method-based protocol on body fluid balance and stress-related measures in healthy adult women: A pilot study. J Bodyw Mov Ther. 2025 Dec;45:812-818. doi: 10.1016/j.jbmt.2025.10.012. Epub 2025 Oct 8.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feldenkrais Method - Awareness Through Movement (ATM) in people with Stress, Psychological and Autonomic Nervous System, run by University of Palermo at 1 site in Italy.
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 3 inclusion and 3 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 16 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
Total Body Water (TBW) (time frame: Baseline and post-intervention (8 days)). The study lists 10 primary outcomes in all. 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 NCT07175974, which also lists 1 linked publication.
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 16 Sep 2025; AzTrials last refreshed its copy on 8 Nov 2026.