FatigueNCT01661595
The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue
A study testing Sildenafil and tadalafil in people with Fatigue, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Read more about this study
- Who is it for?
- Ages 50 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Sildenafil and tadalafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 50-60 years of age
- Ability to sign consent form (score>23 on the 30-item Mini Mental Status examination, MMSE)
- Stable body weight for at least three months.
Who cannot join
- Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year).
- Pregnancy
- Significant heart, liver, kidney, blood or respiratory disease.
- Peripheral vascular disease.
- Diabetes mellitus or other untreated endocrine disease.
- Active cancer
Show all 12Show fewer
- Use of nitrates.
- Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.
- Alcohol or drug abuse.
- Severe depression (>5 on the 15-item Geriatric Depression Scale, GDS).
- Cardiac abnormalities such as cardiac shunt or previously diagnosed pulmonary hypertension.
- Systolic blood pressure <100 or>150, diastolic blood pressure <60 or 90>. This range is smaller than the acceptable range stated in the prescribing information for sildenafil/tadalafil (90/50 and <170/110).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Medical Branch
Galveston, Texas, 77555-0361
About this study
Official title: The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue.
This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and fatigability.
Read the detailed description
The Investigators hypothesize that upregulation of skeletal muscle NO-cGMP mediated responses through phosphodiesterase (PDE) inhibition by sildenafil or tadalafil causes an acute anabolic response of skeletal muscle protein synthesis. NO is well-known to elicit vasodilation through stimulation of cGMP signaling, and NO-mediated changes in muscle perfusion may influence both skeletal muscle anabolism and perceptual fatigue. To measure skeletal muscle protein synthesis, we will infuse a stable isotope tracer of phenylalanine and measure its incorporation into skeletal muscle proteins following a dose of sildenafil, tadalafil, or placebo. The Investigators will also determine whether differences exist between men and women in response to PDE inhibition. As skeletal muscle NO-cGMP signaling has been implicated in fatigue responses, we will assess the acute effect of sildenafil and tadalafil on fatigue. Fatigue can be manifested both as a performance deficit at a local level (e.g., a reduced ability of skeletal muscle to produce power or force) as well as a subjective experience of lacking physical or mental energy. Accordingly, we will use more than one means (skeletal muscle performance, fatigue questionnaires, accelerometers) to study fatigue. The Investigators hypothesize that sildenafil or tadalafil will acutely reduce exercise-associated fatigability and skeletal muscle fatigue development
- Conditions
- Fatigue
- Being tested
- Sildenafil, tadalafil, Placebo
- Keywords
- Fatigue, Fatigability, Surface Electromyography (sEMG), cyclic guanosine monophosphate (cGMP), Nitric Oxide (NO), NO-cGMP, Phosphodiesterase (PDE), Sildenafil, Tadalafil, Isotope, Infusion, Anabolism, Upregulation, Accelerometer, Placebo, Nitrosylation
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
Also called Viagra, Revatio
50 mg/day for 4 weeks
tadalafilDrug
Also called Cialis, Adcirca
10 mg/day for 4 weeks.
PlaceboDrug
Placebo 1 capsule per day for four weeks.
| Study group | Role | What they receive |
|---|---|---|
| Sildenafil / Placebo | Active comparator | 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8. Receives: Drug: Sildenafil; Drug: Placebo |
| Tadalafil / Placebo | Active comparator | 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8. Receives: Drug: tadalafil; Drug: Placebo |
| Placebo / Sildenafil | Active comparator | Placebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8. Receives: Drug: Sildenafil; Drug: Placebo |
| Placebo / Tadalafil | Active comparator | Placebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8. Receives: Drug: tadalafil; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo
Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.
Measured: after 4 weeks of placebo
Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug
Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.
Measured: after 4 weeks of active drug
Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo
The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.
Measured: after 4 weeks of placebo
Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug
The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.
Measured: after 4 weeks of active drug
Secondary outcomes (15)
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of placebo
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.
Peak isometric strength is measured on a Biodex System 4 Pro. This test is isolated to the quadricep muscle of one leg. Isometric test is performed at 90 degrees with 5 seconds of force production for each contraction and 15 seconds of rest. 1 set of 3 contractions at 100% force performed. Isometric strength was measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of active drug
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of placebo
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug
Isokinetic strength (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 1 set of 3 contractions were performed at 100% force. Isokinetic strength will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of active drug
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.
Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 0
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.
Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 4
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.
Lean Body Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 8
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.
Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 0
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.
Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 4
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.
Fat Mass is calculated from a whole body scan measured on a dual energy x-ray absorptiometry.
Measured: week 8
Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo
Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of placebo
Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug
Walking performance will be assessed during 2 minutes of walking in long corridor hallways. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 2 minutes. Distance traveled for the 2 minutes will be recorded. The walking test will be completed at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug.
Measured: after 4 weeks of active drug
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.
Measured: Week 0
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.
Measured: week 4
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8
Fatigue symptoms will be measured using the 30-item Multidimensional Fatigue Symptom Inventory - Short Form, a validated measure that yields one overall score of total fatigue calculated using five sub scales (general, physical, emotional, mental, vigor). With the exception of the vigor sub scale, higher scores indicate greater fatigue. Total fatigue score is calculated by summing the sub categories (general, physical, emotional and mental) and subtracting vigor. Total scores range from -24 to 96, with a higher score indicating more fatigue.
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startNov 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FatigueStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Subjects were assigned to one of 4 arms: 1. Sildenafil (50mg/day) for weeks 0-4. Placebo for weeks 5-8. 2. Tadalafil (10mg/day) for weeks 0-4. Placebo for weeks 5-8. 3. Placebo for weeks 0-4. Sildenafil (50mg/day) for weeks 5-8. 4. Placebo for weeks 0-4. Tadalafil (10mg/day) for weeks 5-8.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melinda Sheffield-Moore, PhD, Principal investigator, University of Texas Medical Branch, Galveston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661595
- Sponsor's protocol ID
- 12-153
- Status last verified
- Apr 2018
- First submitted
- 7 Aug 2012
- Last updated
- 17 Jul 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Sildenafil and Tadalafil on Skeletal Muscle and Perceptual Fatigue.
- ClinicalTrials.gov ID
- NCT01661595
- Acronym / sponsor ID
- 12-153
- Conditions
- Fatigue
- Keywords
- Fatigue, Fatigability, Surface Electromyography (sEMG), cyclic guanosine monophosphate (cGMP), Nitric Oxide (NO), NO-cGMP, Phosphodiesterase (PDE), Sildenafil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Posted 17 Jul 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is funded by the Moody Endowment. In this project, we will investigate the potential effect of skeletal muscle nitric oxide (NO) production on skeletal muscle anabolism, muscle strength, physical function, and body composition in older individuals. Further, we will determine whether augmentation of NO-mediated signaling reduces fatigue and fatigability.
Detailed description
The Investigators hypothesize that upregulation of skeletal muscle NO-cGMP mediated responses through phosphodiesterase (PDE) inhibition by sildenafil or tadalafil causes an acute anabolic response of skeletal muscle protein synthesis. NO is well-known to elicit vasodilation through stimulation of cGMP signaling, and NO-mediated changes in muscle perfusion may influence both skeletal muscle anabolism and perceptual fatigue. To measure skeletal muscle protein synthesis, we will infuse a stable isotope tracer of phenylalanine and measure its incorporation into skeletal muscle proteins following a dose of sildenafil, tadalafil, or placebo. The Investigators will also determine whether differences exist between men and women in response to PDE inhibition. As skeletal muscle NO-cGMP signaling has been implicated in fatigue responses, we will assess the acute effect of sildenafil and tadalafil on fatigue. Fatigue can be manifested both as a performance deficit at a local level (e.g., a reduced ability of skeletal muscle to produce power or force) as well as a subjective experience of lacking physical or mental energy. Accordingly, we will use more than one means (skeletal muscle performance, fatigue questionnaires, accelerometers) to study fatigue. The Investigators hypothesize that sildenafil or tadalafil will acutely reduce exercise-associated fatigability and skeletal muscle fatigue development
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Subjects were assigned to one of 4 arms: 1. Sildenafil (50mg/day) for weeks 0-4. Placebo for weeks 5-8. 2. Tadalafil (10mg/day) for weeks 0-4. Placebo for weeks 5-8. 3. Placebo for weeks 0-4. Sildenafil (50mg/day) for weeks 5-8. 4. Placebo for weeks 0-4. Tadalafil (10mg/day) for weeks 5-8.
| Arm | Type | Receives |
|---|---|---|
| Sildenafil / Placebo | Active comparator | Drug: Sildenafil, Drug: Placebo50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 0-4. Placebo for weeks 5-8. |
| Tadalafil / Placebo | Active comparator | Drug: tadalafil, Drug: Placebo10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 0-4. Placebo for weeks 5-8. |
| Placebo / Sildenafil | Active comparator | Drug: Sildenafil, Drug: PlaceboPlacebo for weeks 0-4. 50 mg/day Sildenafil: (Other Name: Viagra, Revatio) for weeks 5-8. |
| Placebo / Tadalafil | Active comparator | Drug: tadalafil, Drug: PlaceboPlacebo for weeks 0-4. 10 mg/day Tadalafil: (Other Name: Cialis, Adcirca) for weeks 5-8. |
Who may qualify
- Ages
- 50 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 50-60 years of age
- Ability to sign consent form (score>23 on the 30-item Mini Mental Status examination, MMSE)
- Stable body weight for at least three months.
Key exclusion criteria (12 listed)
- Physical dependence or frailty (impairment in any of the Activities of Daily Living (ADL), history of falls (>2/year) or significant weight loss in the past year).
- Pregnancy
- Significant heart, liver, kidney, blood or respiratory disease.
- Peripheral vascular disease.
- Diabetes mellitus or other untreated endocrine disease.
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 |
|---|---|---|
| SildenafilAlso: Viagra, Revatio50 mg/day for 4 weeks | Drug | Placebo / Sildenafil, Sildenafil / Placebo |
| tadalafilAlso: Cialis, Adcirca10 mg/day for 4 weeks. | Drug | Placebo / Tadalafil, Tadalafil / Placebo |
| PlaceboPlacebo 1 capsule per day for four weeks. | Drug | Placebo / Sildenafil, Placebo / Tadalafil, Sildenafil / Placebo, Tadalafil / Placebo |
Primary outcome
Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo
Time frame: after 4 weeks of placebo
Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.
Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Active Drug
Time frame: after 4 weeks of active drug
Isokinetic Fatigue Measure (knee extension) is measured on a Biodex System Pro 4 within a 75 degree range of motion. Subjects performed concentric contractions at a fixed speed of 120 degree/sec. 50 contractions were performed at 100% force, one contraction every second. Isokinetic fatigue will be measured at week 4 and week 8. Depending on grouping, the week 4 and week 8 measures may be placebo or active drug. Data will be reported as after 4 weeks of placebo or after 4 weeks of active drug. Data is presented as mean maximum force over all 50 kicks.
Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Placebo
Time frame: after 4 weeks of placebo
The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test after 4 weeks of placebo. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.
Exercised Induced Fatigability as Measured by Fatigue Rating Scale After 4 Weeks of Active Drug
Time frame: after 4 weeks of active drug
The fatigue rating scale is a scale from 0 to 10 with 0 being no fatigue at all and 10 being the worst fatigue the subject can imagine. The subject is asked to rate their level of fatigue in their leg. This test was performed before and immedicately after the Biodex leg fatigue test. Data is presented as change in scale from pre fatigue test to post fatigue test, with a higher score indicating a greater level of fatigue.
15 secondary outcomes
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo
Time frame: after 4 weeks of placebo
Maximum Peak Isometric Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug.
Time frame: after 4 weeks of active drug
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Placebo.
Time frame: after 4 weeks of placebo
Maximum Peak Isokinetic Leg Strength as Measured by Biodex Pro4 After 4 Weeks of Active Drug
Time frame: after 4 weeks of active drug
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.
Time frame: week 0
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.
Time frame: week 4
Lean Body Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.
Time frame: week 8
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 0.
Time frame: week 0
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 4.
Time frame: week 4
Fat Mass as Measured by Dual Energy X-ray Absorptiometry at Week 8.
Time frame: week 8
Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Placebo
Time frame: after 4 weeks of placebo
Walking Distance at 100% Effort as Measured by Walking Test After 4 Weeks of Active Drug
Time frame: after 4 weeks of active drug
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 0
Time frame: Week 0
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 4
Time frame: week 4
Perceptual Fatigue as Measured by Multidimensional Fatigue Symptom Inventory - Short Form Total Score at Week 8
Time frame: week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Melinda Sheffield-Moore, PhD principal investigator
University of Texas Medical Branch, Galveston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sildenafil and tadalafil in people with Fatigue, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 12 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 17 Jul 2018. 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 United States. 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?
Yes. Results are posted in the registry (first posted 17 Jul 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Skeletal Muscle Fatigue as Measured by Biodex 4 Pro After 4 Weeks of Placebo (time frame: after 4 weeks of placebo). The study lists 4 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 17 Jul 2018.