Chronic Fatigue Syndrome
Conditions
Keywords
Heart Rhythm Biofeedback; Hydrogen Water
Brief summary
The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and OTC supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better.
Detailed description
The aim of this 10-week pilot study is to explore the potential benefit of two recently developed non-invasive interventions, heart rate variability biofeedback (HRV-BF) and over the counter (OTC) supplement hydrogen water, for the symptoms of chronic fatigue syndrome (CFS). Symptom measures and heart monitoring information will be generated by this study. Given the lack of effective treatments in this illness, these two non-invasive home-based treatments may help patients feel and function better. Participants will be randomized to one of the three study condition, HRV-BF alone, hydrogen water alone or combined HRV-BF and hydrogen water. All interventions are home-based with no in person visits. All communications with participants will be via virtual call, phone call, email and land mail.
Interventions
BEHAVIORALHeart Rhythm Biofeedback
Heart rhythm biofeedback is a non-invasive intervention intended to improve heart rate variability and physical resilience that is often limited in chronic fatigue syndrome
DIETARY_SUPPLEMENTHydrogen Water
Hydrogen water, if ingested daily over several weeks, may have antioxidant and anti-inflammatory effects in chronic fatigue syndrome
COMBINATION_PRODUCTCombined treatment: Heart rhythm biofeedback plus hydrogen water
This treatment is intended to explore the possible additive or synergistic effects of combining heart rhythm biofeedback and hydrogen water.
Sponsors
Natural Wellness Now Health Products
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Each participant fill out online outcome forms that involve no interaction with the principal investigator or study staff, thus avoiding any staff-specific influence on online outcome forms.
Intervention model description
This clinical study involves three active intervention groups: group 1 receiving heart rhythm biofeedback alone, group receiving hydrogen water alone, and group 3 receiving both heart rhythm biofeedback and hydrogen water.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
Diagnosis of chronic fatigue, chronic fatigue syndrome, or something similar. ages 18-65. - BMI\>30.
Exclusion criteria
* Other major medical condition or regular medication that produces fatigue. No home computer or internet access. No smart phone.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fatigue Severity Scale | 8 weeks | self-report measure of fatigue impact on functioning.Minimum value=1; Maximum value=7; Range: 1.00-7.00. High scores indicate more sever fatigue and a worse outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Short Form-36 Physical Function Subscale | 8 weeks | Self-report measure of physical functioning. The short-form 36 physical function subscale is composed of ten items encompassing a hierarchical range of difficulties. Each item is scores on the basis of the limitations perceived by surveyed individuals. Item scores (1, 2, or 3) are summed to obtain a total score, which can then be scaled relative to its range. Higher scores indicate higher physical function. |
| Depression, Anxiety and Stress Scale | 8 weeks | Self-report measure if depression, anxiety and stress symptoms. This 21 item stress measure contains three 7-item subscales: anxiety, depression and stress. Domain scores are calculated by summing all items in a domain and multiplying by two. |
| Brief Resilience Scale | 8 weeks | This 6 item self-report scale focuses on how quickly an individuals bounces back and physically and emotionally exhausting events. 5 answer choices range from strongly disagree to strongly agree. Higher scores indicate higher resilience. |
Countries
United States
Contacts
Primary ContactFRED FRIEDBERG, PhD
Backup ContactDaniel Gordon, BA
Outcome results
None listed