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Trial record 2 of 4 for:    APBA2

Treatment Trial of Thermoregulatory Disturbances in Adolescent Anorexia Nervosa Patients With Either Ginger Powder Footbaths or Warm Water Footbaths

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ClinicalTrials.gov Identifier: NCT03886207
Recruitment Status : Recruiting
First Posted : March 22, 2019
Last Update Posted : July 4, 2019
Sponsor:
Collaborator:
Filderklinik, Filderstadt, Germany
Information provided by (Responsible Party):
ARCIM Institute Academic Research in Complementary and Integrative Medicine

Brief Summary:
A study to explore whether warm water footbaths with added ginger powder can improve thermoregulatory processes in adolescent anorexia nervosa patients and provide them with an increase in subjective feeling of warmth. The participants will receive a warm footbath four times a week for six weeks with a physiological and psychological testing point once before the beginning of the six-week footbath period and once after.

Condition or disease Intervention/treatment Phase
Adolescent Anorexia Nervosa Other: ginger powder footbath Other: warm water only footbath Not Applicable

Detailed Description:
This is a two-arm randomized controlled trial to evaluate the efficacy of warm water footbaths with added ginger powder (experimental) compared to warm water only footbaths (control) in adolescent anorexia nervosa patients. Participants will receive footbaths 4 times per week before bed-time over a period of six weeks.The main focus is on subjective increase in overall body warmth. Moreover, core body temperature, skin temperature at the extremities and several psychological as well as physiological scores and parameters are assessed before and after the six-week intervention. A follow-up is planned at six months post intervention, where core body temperature, physiological and psychological parameters are once more tested.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are age and core body temperature stratified and then randomized to one of the two groups (footbath with warm water with additional ginger powder or warm water only). Assessments are taken before and after the six-week intervention phase as well as at six-month follow-up.
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Foot Baths With and Without Ginger Powder Additive on the Subjective Feeling of Warmth and on Body Core Temperature of Adolescents With Anorexia Nervosa - a Randomized, Controlled Pilot Study
Actual Study Start Date : April 8, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : October 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Drinking Water

Arm Intervention/treatment
Experimental: Warm water with ginger powder footbath
Participants who receive a warm water with added ginger powder footbath four times a week over a six-week period.
Other: ginger powder footbath
38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine

Active Comparator: Warm water only footbath
Participants who receive a warm water only footbath four times a week over a six-week period.
Other: warm water only footbath
38-40° C warm water footbath without any additive reaching up to mid-calf level




Primary Outcome Measures :
  1. Chnge in Subjective feeling of overall warmth [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention) ]
    Self-reported feeling of overall warmth measured using the HeWEF 1.2 (Herdecker Wärmeempfindungs-Fragebogen) overall warmth perception questionnaire


Secondary Outcome Measures :
  1. Core body temperature [ Time Frame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline (post intervention), at six-month follow-up ]
    Core body temperature measured using an infrared tympanical thermometer as used in clinical routine

  2. Face surface temperature [ Time Frame: Baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Surface temperature in the face measured using high-resolution infrared thermography

  3. Feet surface temperature [ Time Frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Surface temperature at the feet measured using high-resolution infrared thermography

  4. Hand surface temperature [ Time Frame: Baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Surface temperature on the hands measured using high-resolution infrared thermography

  5. Abdomen surface temperature [ Time Frame: Baseline (pre intervention) and after 6 weeks (post intervention) ]
    Surface temperature at the abdomen measured using high-resolution infrared thermography

  6. 24-hour feet surface temperature [ Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline(post intervention) ]
    24 hour surface temperature at the feet measured using a surface data-logger (i-Button TM)

  7. 24-hour hand surface temperature [ Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) ]
    24 hour surface temperature on the hands measured using a surface data-logger (i-Button TM)

  8. 24-hour abdomen surface temperature [ Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) ]
    24 hour surface temperature at the abdomen measured using a surface data-logger (i-Button TM)

  9. 24-hour torso surface temperature [ Time Frame: Over 24 hours at baseline (pre intervention) and over 24 hours 6 weeks after baseline (post intervention) ]
    24 hour surface temperature at the upper torso measured using a surface data-logger (i-Button TM)

  10. Body Mass Index [ Time Frame: Baseline (pre intervention),weekly during intervention, 6 weeks after baseline (post intervention) and at six-month follow-up ]
    Body Mass Index (BMI) Calculated as (Weight in Kg)/〖(Height in m)^2〗

  11. Pulse Transit Time (PTT) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    PTT in ms, measured with the GeTeMed Vitaguard 3100

  12. Perfusion Index (PI) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    PI, measured with the GeTeMed Vitaguard 3100

  13. Peak to Peak Time (PPT) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Peak to Peak Time (PPT, ms) measured with the GeTeMed Vitaguard 3100

  14. SlopeInW1 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and after 6 weeks (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  15. SlopeInW2 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  16. SlopeInW3 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  17. SlopeInW4 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  18. Stiffness Index [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  19. Reflection Index [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  20. TimeTX [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    TimeTX in ms (millisecond), measured with the GeTeMed Vitaguard 3100

  21. TimeTY [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    TimeTY in ms, measured with the GeTeMed Vitaguard 3100

  22. QuotTYTX [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  23. AreaAX [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  24. AreaAY [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  25. QuotAYAX [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  26. AreaAV [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  27. AreaAW [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  28. QuotAWAV [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  29. QuotTVTW [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Measured with the GeTeMed Vitaguard 3100

  30. TimeTV [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    TimeTV in ms, measured with the GeTeMed Vitaguard 3100

  31. TimeTW [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    TimeTW in ms, measured with the GeTeMed Vitaguard 3100

  32. MinT1 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak

  33. MinT2 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Minimum of the pulse wave measured with the GeTeMed Vitaguard 3100 device at the beginning of the second peak

  34. MaxT1 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the first peak

  35. MaxT2 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Maximum of the pulse wave measured with the GeTeMed Vitaguard 3100 at the beginning of the second peak

  36. QuotHRRespRate [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Quotient of heart and respiratory rates measured with the GeTeMed Vitaguard 3100

  37. Heart rate [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    beats per minute (bpm) measured with the GeTeMed Vitaguard 3100

  38. Respiratory rate [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    measured with the GeTeMed Vitaguard 3100

  39. SDNN (standard deviation of normal to normal) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Standard deviation of normal to normal beats, measured with the GeTeMed Vitaguard 3100

  40. RMSSD (Root mean square of successive differences) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Root mean square of successive differences, measured with the GeTeMed Vitaguard 3100

  41. pNN50 [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Number of pairs of successive heart rate intervals that differ by more than 50 ms

  42. HF (high frequency) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline(post intervention) ]
    Area under the curve between the frequency of 0.15 to 0.4Hz measured with the GeTeMed Vitaguard 3100

  43. LF (low frequency) [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Area under the curve between the frequency of 0.04 to 0.15Hz measured with the GeTeMed Vitaguard 3100

  44. LF/HF-Ratio [ Time Frame: Continuously over 15 minutes at baseline (pre intervention) and 6 weeks after baseline (post intervention) ]
    Ratio of two bands from frequency domain analysis: LF band (0.04-0.15 Hz), HF band (0.15-0.40 Hz), measured with the GeTeMed Vitaguard 3100

  45. Pittsburgh sleep quality index [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the PSQI (Pittsburgh sleep quality index)

  46. Eating Disorder Inventory -2 [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the EDI-2 (Eating Disorder Inventory)

  47. Eating Disorder Examination- Questionnaire [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the EDE-Q (Eating Disorder Examination)

  48. Becks Depressions Inventar [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the BDI-II (Becks Depression Inventar)

  49. Hospital Anxiety and Depression Scale subscale Anxiety [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Anxiety Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)

  50. Hospital Anxiety and Depression Scale subscale Depression [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Depression Sum-Score of the HADS (Hospital Anxiety and Depression scale) ranging from 0-21 with a cutoff at >10 (being evaluated as pathological)

  51. Body Image State Scale [ Time Frame: Baseline (pre intervention),6 weeks after baseline (post intervention), at six-month follow-up ]
    Mean of all six item values (range from 0-9) with higher values indicating a positive body image state of the BISS (Body Image State Scale)

  52. Positive And Negative Affect Schedule [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the PANAS-X (Positive and negative affect schedule)

  53. Short Form Health Survey 12 [ Time Frame: Baseline (pre intervention), 6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the SF-12 (Short Form 12)

  54. Basler Befindlichkeits Skala [ Time Frame: Baseline (pre intervention), once per week during intervention, 6 weeks after baseline(post intervention), at six-month follow-up ]
    Scores of the BBS (Basler Befindlichkeits Skala =basler mood questionnaire)

  55. Body Shape Questionnaire [ Time Frame: Baseline (pre intervention), once per week during intervention,6 weeks after baseline (post intervention), at six-month follow-up ]
    Scores of the BSQ (Body Shape Questionnaire)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • main diagnosis: Anorexia nervosa
  • written informed consent of participants and legal guardians

Exclusion Criteria:

  • other eating disorder diagnosis apart from Anorexia nervosa
  • known allergic reaction to ginger

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03886207


Contacts
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Contact: Jan Vagedes, Dr. med. 49 711 7703- ext -1688 j.vagedes@arcim-institute.de

Locations
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Germany
ARCIM Institute Recruiting
Filderstadt, Baden Württemberg, Germany, 70794
Contact: Jan Vagedes, Dr. MD    +49 711 7703 1688      
Sponsors and Collaborators
ARCIM Institute Academic Research in Complementary and Integrative Medicine
Filderklinik, Filderstadt, Germany
Investigators
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Principal Investigator: Jan Vagedes, Dr. med. ARCIM Institute

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Responsible Party: ARCIM Institute Academic Research in Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT03886207     History of Changes
Other Study ID Numbers: ANS_03
First Posted: March 22, 2019    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ARCIM Institute Academic Research in Complementary and Integrative Medicine:
Anorexia
Footbath
Ginger powder
Thermogenic substances
Thermoregulation
External applications
Anthroposophic medicine
Eating disorders
Additional relevant MeSH terms:
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Anorexia
Anorexia Nervosa
Signs and Symptoms, Digestive
Signs and Symptoms
Feeding and Eating Disorders
Mental Disorders