Depression, Pain, Physical Activity, Post-polio Syndrome, Sleep Disorders
Conditions
Keywords
disability, polio, rehabilitation, wellness
Brief summary
In this study, people who have symptoms of post polio will take oral glutathione supplements for three months. Their levels of fatigue, physical activity and sleep efficiency will be assessed.
Detailed description
Subjects will take a glutathione supplement by mouth for three months after an initial medical visit, blood draw and physical exam. There are four timepoints during the three months when subjects will fill out surveys and record food intake and sleep times in diaries for seven days. They will also wear a small device for seven days, a Sensewear monitor that records physical activity, body temperature and other measures. After the fourth timepoint they will return to the medical center for another physical exam and blood draw. Physicians trained in physical medicine and rehabilitation will be monitoring the study.
Interventions
DIETARY_SUPPLEMENTGlutathione
glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
Sponsors
Penn State University
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Ability to walk 100 feet with usual assistive devices (ex. cane or walker) * Having a function score of 18-32 when tested with the IPPS (Index of Post- Polio Sequelae). This will include people with post-polio symptoms in a very specific range of severity.
Exclusion criteria
* Having another serious medical condition (cancer, multiple sclerosis, etc.)or inflammatory disease (ie., lupus) * Currently taking glutathione or other antioxidants
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | Baseline, 1 month, 2 months and 3 months | Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function. |
| Sleep Efficiency | Baseline, 1 month, 2 months and 3 months | The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed. |
| Steps Per Day | Baseline, 1 month, 2 months and 3 months | Count of steps per day using activity monitor worn on upper arm. |
| PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | Baseline, 1 month, 2 months and 3 months | Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Group All subjects were assigned the intervention. The intervention was a three-month trial of twice daily, oral, 1,000 mg glutathione supplements (Glutathione 500 Ultrathione, The Glutathione Corporation, Elmsford, New York; 500 mg. capsule with 250 mg. ascorbic acid). | 20 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
Baseline characteristics
| Characteristic | Study Group |
|---|---|
| Age, Continuous | 60.85 years STANDARD_DEVIATION 3.89 |
| Gender Female | 9 Participants |
| Gender Male | 11 Participants |
| Physical activity, number of steps daily | 4004.1 steps/day STANDARD_DEVIATION 3357.9 |
| PROMIS Fatigue | 56.0 units on a scale STANDARD_DEVIATION 8.7 |
| PROMIS Physical Functioning | 37.8 units on a scale STANDARD_DEVIATION 4.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 18 Participants |
| Region of Enrollment United States | 20 participants |
| Subjective sleep efficiency | 82.0 percentage STANDARD_DEVIATION 14.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 1 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue
Assesses fatigue from mild subjective feelings to an overwhelming, debilitating, and sustained sense of exhaustion that is likely to decrease one's ability to carry out daily activities, including the ability to work effectively and to function at one's usual level in family or social roles. Fatigue is divided conceptually into the experience of fatigue (e.g., frequency, duration, and intensity), and the impact of fatigue upon physical, mental and social activities. Scores are on a T-metric with mean of 50 and standard deviation of 10; higher scores indicate greater fatigue.
Time frame: Baseline, 1 month, 2 months and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | Baseline | 56.0 units on a scale | Standard Deviation 8.7 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | 1 month | 54.9 units on a scale | Standard Deviation 7.1 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | 2 months | 53.4 units on a scale | Standard Deviation 9.2 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Fatigue | 3 months | 52.8 units on a scale | Standard Deviation 9.8 |
Comparison: Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.p-value: 0.0795% CI: [-2.21, 0.1]Mixed Models Analysis
Primary
PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning
Ability to carry out activities that require physical actions, ranging from self-care (activities of daily living) to more complex activities that require a combination of skills, often within a social context. Scores are standardized T-scores with mean of 50 and standard deviation of 10; higher scores indicate better physical function.
Time frame: Baseline, 1 month, 2 months and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | Baseline | 37.8 units on a scale | Standard Deviation 4.6 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | 1 month | 37.9 units on a scale | Standard Deviation 4.3 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | 2 months | 37.5 units on a scale | Standard Deviation 5.6 |
| Study Group | PROMIS (Patient Reported Outcomes Measurement Information System) Physical Functioning | 3 months | 38.1 units on a scale | Standard Deviation 5.1 |
Comparison: Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.p-value: 0.6695% CI: [-0.67, 0.95]Mixed Models Analysis
Primary
Sleep Efficiency
The ratio of time asleep over time in bed gathered from sleep diaries completed at bedtime and at awakening. Scores range from 0 to 100%, higher values indicate better sleep efficiency or more time sleeping in bed.
Time frame: Baseline, 1 month, 2 months and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Sleep Efficiency | Baseline | 82.1 units on a scale | Standard Deviation 14.6 |
| Study Group | Sleep Efficiency | 1 month | 86.9 units on a scale | Standard Deviation 9.2 |
| Study Group | Sleep Efficiency | 2 months | 87.6 units on a scale | Standard Deviation 8.4 |
| Study Group | Sleep Efficiency | 3 months | 87.8 units on a scale | Standard Deviation 8.2 |
Comparison: Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.p-value: 0.4495% CI: [-0.01, 0.02]Mixed Models Analysis
Primary
Steps Per Day
Count of steps per day using activity monitor worn on upper arm.
Time frame: Baseline, 1 month, 2 months and 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Group | Steps Per Day | Baseline | 4004.1 steps per day | Standard Deviation 3357.9 |
| Study Group | Steps Per Day | 1 month | 3590.7 steps per day | Standard Deviation 2928.3 |
| Study Group | Steps Per Day | 2 months | 3598.9 steps per day | Standard Deviation 3139.3 |
| Study Group | Steps Per Day | 3 months | 3693.1 steps per day | Standard Deviation 3317.8 |
Comparison: Linear mixed modeling (LMM) with random effects for intercept and repeated effects for assessment period was used to analyze change over time for study outcomes. The primary predictor of interest in this study was the relationship of time to each of the outcomes to evaluate the potential effect of the intervention. Independent LMMs were used to study outcomes.p-value: 0.3595% CI: [-178.93, 470.02]Mixed Models Analysis