Healthy SubjectsNCT03871504
The Influence of Baseline Sensitivity and Expectation on Exercise-induced Hypoalgesia in Young Healthy Adults
A study testing Submaximal isometric exercise in people with Healthy Subjects, run by Marquette University at 1 site in United States.
Trial summary
The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. Pain assessment will be done with different intensities of noxious stimuli. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Subjects
- What is being tested?
- Submaximal isometric exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2017to 30 Dec 2022
- 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
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults
- English proficiency
Who cannot join
- Acute pain condition
- Chronic pain condition
- Mental health disorder
- Cardiovascular disease
- Any chronic illness
- Difficulty with physical exercise
Show all 12Show fewer
- Recent surgery
- Pulmonary disease
- Diabetes
- Smoking
- Raynaud disease
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Marquette University
Milwaukee, Wisconsin, 53201
Marie Hoeger Bement, PT, PhD
About this study
Official title: Quantitative Sensory Testing, Physical Activity, and Body Composition in Adults
The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. Pain assessment will be done with different intensities of noxious stimuli. In addition, the expectation of how exercise impacts pain will be studied.
Read the detailed description
The relation between baseline pain sensitivity and the pain response following exercise is not clear. The aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.
- Conditions
- Healthy Subjects
- Being tested
- Submaximal isometric exercise
- Keywords
- exercise, hypoalgesia, pain, expectation
- Medical subject headings
- Motor Activity, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Submaximal isometric exerciseOther
The exercise is a submaximal isometric contraction
| Study group | Role | What they receive |
|---|---|---|
| submaximal isometric exercise. | Experimental | submaximal isometric exercise will be performed. Receives: Other: Submaximal isometric exercise |
| Quiet rest. | No intervention | Subject will rest in seating position for a period that mimics the exercise time. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change from baseline of pain ratings during temporal summation of pressure pain assessment
Temporal summation is the increase of pain over time caused by a constant or repetitive noxious stimulus. Pain reports will be obtained during the application of constant mechanical stimulus with various intensities. Subjects will be asked to rate the pain using a numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain). Pain ratings will be obtained at the beginning, during, and at the end of the test while a noxious stimulus is applied to the index finger. The change of pain ratings relative to baseline after exercise or quiet rest will be assessed.
Measured: Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.
Secondary outcomes (8)
Expectation
Subjects will be asked about their expectation of whether exercise will increase, decrease, or have no effect on the pain.
Measured: Before exercise which will be on day 1 and day 7 of data collection.
State version of the State-Trait Anxiety Inventory (STAI)
A 20-item questionnaire from state-trait anxiety inventory that evaluates different feelings the subject may or may not have at the moment. The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater state anxiety levels.
Measured: After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
Trait version of the State-Trait Anxiety Inventory (STAI)
A 20-item questionnaire from state-trait anxiety inventory that evaluates how the subject feels in general and not restricted to the current moment. The score of the questionnaire ranges from 0 to 80. Higher scores indicate greater trait anxiety levels.
Measured: Baseline (beginning of session 1) which is day 1 of the data collection.
Pain catastrophizing scale
A 13-item scale that evaluates if the subject has an exaggerated negative mental set towards pain. It has 3 sub-scales which are magnification, rumination, and helplessness. The scores of the sub-scales are summed to get the total score. The total score ranges from 0 to 52. Greater scores indicate greater catastrophizing thinking.
Measured: Baseline (beginning of session 1) which is day 1 of the data collection.
Situational pain catastrophizing scale
A 6-item questionnaire that explores the negative mental set or catastrophizing thinking in reference to a particular experimental pain experience (i.e., temporal summation protocol). The score ranges from 0 to 24 with higher scores indicating greater situational catastrophizing.
Measured: After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
Physical activity assessment using International physical activity questionnaire.
International physical activity questionnaire (IPAQ) will be used to assess physical activity in the past week. IPAQ evaluates physical activity not only related to leisure time but also related to other domains such as transportation, work, gardening or house related physical activities. The questionnaire has been shown to be reliable and valid. The time spent in moderate to vigorous physical activity (minutes/ week) from every domain will be summed with 0 indicating no time (minutes / week) spent moderate to vigorous activities and higher values indicate greater time spent in moderate to vigorous physical activity.
Measured: Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
Muscle mass assessment using Dual-energy x-ray absorptiometry.
Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess muscle mass.
Measured: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Fat mass assessment using Dual-energy x-ray absorptiometry.
Dual-energy x-ray absorptiometry (General Electric Healthcare, Madison, Wisconsin) is an x-ray scan that is used to assess fat mass.
Measured: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start25 Nov 2017
- Primary completion30 Dec 2022 (estimated)
- Study completion30 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy SubjectsStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- All subjects will participate in two randomized sessions (an exercise session and control session). The exercise session consists of submaximal isometric exercise while the quiet rest session consists of a rest for a period that mimics the time spent in exercise.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Marquette University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie Hoeger Bement, PT, PhD, Principal investigator, Marquette University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03871504
- Sponsor's protocol ID
- HR-2999
- Status last verified
- Mar 2019
- First submitted
- 13 Dec 2018
- Last updated
- 12 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Sensory Testing, Physical Activity, and Body Composition in Adults
- ClinicalTrials.gov ID
- NCT03871504
- Acronym / sponsor ID
- HR-2999
- Conditions
- Healthy Subjects
- Keywords
- exercise, hypoalgesia, pain, expectation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Marquette UniversityUniversity, hospital or other
- Study start
- 25 Nov 2017 (actual)
- Primary completion
- 30 Dec 2022 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 12 Mar 2019 (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.
The purpose of this study is to investigate the influence of baseline experimental pain sensitivity and expectation on the pain response following a single exercise session. Pain assessment will be done with different intensities of noxious stimuli. In addition, the expectation of how exercise impacts pain will be studied.
Detailed description
The relation between baseline pain sensitivity and the pain response following exercise is not clear. The aims of this study are to investigate the influence of baseline experimental pain sensitivity on the pain response following submaximal isometric exercise, and whether expectations would influence outcomes with subsequent exposure to exercise.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- All subjects will participate in two randomized sessions (an exercise session and control session). The exercise session consists of submaximal isometric exercise while the quiet rest session consists of a rest for a period that mimics the time spent in exercise.
| Arm | Type | Receives |
|---|---|---|
| submaximal isometric exercise. | Experimental | Other: Submaximal isometric exercisesubmaximal isometric exercise will be performed. |
| Quiet rest. | No intervention | –Subject will rest in seating position for a period that mimics the exercise time. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults
- English proficiency
Key exclusion criteria (12 listed)
- Acute pain condition
- Chronic pain condition
- Mental health disorder
- Cardiovascular disease
- Any chronic illness
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 |
|---|---|---|
| Submaximal isometric exerciseThe exercise is a submaximal isometric contraction | Other | submaximal isometric exercise. |
Primary outcome
The change from baseline of pain ratings during temporal summation of pressure pain assessment
Time frame: Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.
Temporal summation is the increase of pain over time caused by a constant or repetitive noxious stimulus. Pain reports will be obtained during the application of constant mechanical stimulus with various intensities. Subjects will be asked to rate the pain using a numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain). Pain ratings will be obtained at the beginning, during, and at the end of the test while a noxious stimulus is applied to the index finger. The change of pain ratings relative to baseline after exercise or quiet rest will be assessed.
8 secondary outcomes
Expectation
Time frame: Before exercise which will be on day 1 and day 7 of data collection.
State version of the State-Trait Anxiety Inventory (STAI)
Time frame: After each temporal summation protocol in the first and second session which are on day 1 and day 7 of data collection.
Trait version of the State-Trait Anxiety Inventory (STAI)
Time frame: Baseline (beginning of session 1) which is day 1 of the data collection.
Pain catastrophizing scale
Time frame: Baseline (beginning of session 1) which is day 1 of the data collection.
Situational pain catastrophizing scale
Time frame: After each temporal summation protocol in the first and second session which are day 1 and day 7 of data collection.
Physical activity assessment using International physical activity questionnaire.
Time frame: Baseline (beginning of session 1 or 2) which is either day 1 or day 7 of data collection.
Muscle mass assessment using Dual-energy x-ray absorptiometry.
Time frame: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Fat mass assessment using Dual-energy x-ray absorptiometry.
Time frame: Baseline (in the first or second session) which is either day 1 or day 7 of data collection.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
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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.
Marie Hoeger Bement, PT, PhD principal investigator
Marquette University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Submaximal isometric exercise in people with Healthy Subjects, run by Marquette University 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 2 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: status not confirmed, as of the sponsor's last update on 12 Mar 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marie Hoeger Bement, PT, PhD (414-288-6738, mariehoeger.bement@marquette.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change from baseline of pain ratings during temporal summation of pressure pain assessment (time frame: Before and immediately after exercise or quiet rest in session 1 and session 2 which will be on day 1 and day 7 of data collection.). 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 12 Mar 2019.