- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03173755
Pain Discomfort Enjoyment Levels During Moderate Exercise
September 26, 2019 updated by: Martin Binks, Texas Tech University
Relationships of Pain, Discomfort and Enjoyment During Exercise to Weight Status and Diet Quality.
In order to better understand how pre-existing pain and also discomfort/enjoyment during exercise may influence physical activity and be related to body weight the investigators are seeking to examine these as they relate to overweight/obesity compared to normal weight individuals.
Ultimately, the investigators think that people with obesity may have more and be more sensitive to pain and have lower discomfort tolerance that may lead them to experience exercise more negatively.
In the real world, this could result in them stopping exercise sooner or avoiding exercise all together.
Therefore it is important for the investigators to begin to understand this issue better.
In addition, some preliminary studies in animals suggest that the quality of the diet may influence pain sensitivity.
This has yet to be examined in humans.
As such the investigators will examine whether self-reported diet quality and also some markers in participants' blood that can tell the investigators about the recent quality of a person's diet, are related to the measures of pain, enjoyment and discomfort during exercise.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
127
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
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Lubbock, Texas, United States, 79409
- Texas Tech University - Department of Nutritional Sciences
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The study will recruit participants from Lubbock Texas Community and surrounding regions.
Description
Inclusion Criteria:
- Age: 18-60 years.
- BMI ≥ 18.5 kg/m2.
- Typically exercise (moderate-intensity aerobic exercise - e.g. brisk walking) less than 150 minutes per week (last 3 months)
- No known contraindications for participating in up to 42 minutes of moderate intensity physical activity.
- Have not been told by a qualified healthcare provider to avoid moderate physical activity.
Exclusion Criteria:
- Unable/unwilling to provide informed consent.
- Having motor impairment.
- Currently diagnosed with diabetes mellitus, experiencing uncontrolled hypertension (i.e. systolic blood pressure (SBP) > 140 mmHg or diastolic blood pressure (DBP) > 90 mmHg), having a history of ischemic heart disease, cerebrovascular accidents, neurological disease or current/past severe psychiatric illness (e.g. severe depression, psychosis, schizophrenia) that required hospitalization, severe current untreated depression (i.e. score in the severe depression range on the Hospital Anxiety and Depression Scale; HADS), current suicidal ideation, and current or past suicide attempts.
- Women who are pregnant or nursing.
- Diagnosed history of eating disorders such as bulimia nervosa, anorexia nervosa.
- Diagnosed history of substance abuse or alcohol abuse.
- Currently undergoing pain management treatment (pharmacologic and or behavioral).
- Currently taking anti-depressant medicines
- Have been instructed by a qualified healthcare provider to refrain from moderate physical activity at any time during the last 12 months (reasons other than minor orthopedic injury etc.).
- Any implanted medical devices (e.g. pacemaker).
- Currently smoking (within last 12 months).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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People with normal weight
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people with overweight and obesity
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI.
Time Frame: Baseline
|
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI (weight and height will be combined to report BMI in kg/m2).
|
Baseline
|
|
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI.
Time Frame: Baseline
|
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
|
Baseline
|
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Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI.
Time Frame: minute zero through minute 42 of single exercise testing session (pre- post- session)
|
Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI (weight and height will be combined to report BMI in kg/m2).
|
minute zero through minute 42 of single exercise testing session (pre- post- session)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index.
Time Frame: Baseline
|
Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index (DQI; is a factor analytically derived composite score of 5 nutritional quality biomarkers <plasma alkylresorcinol, Omega-3 index, serum fatty acid composition, serum carotenoids, and serum selenium>.)
|
Baseline
|
|
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index.
Time Frame: Baseline
|
Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index (DQI is a factor analytically derived composite score of 5 nutritional quality biomarkers < plasma alkylresorcinol, Omega-3 index, serum fatty acid composition, serum carotenoids, and serum selenium>.)
|
Baseline
|
|
Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI.
Time Frame: Baseline
|
Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI (weight and height will be combined to report BMI in kg/m2).
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Martin Binks, PhD, Texas Tech University - Department of Nutritional Sciences
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 29, 2017
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
May 26, 2017
First Submitted That Met QC Criteria
May 30, 2017
First Posted (Actual)
June 2, 2017
Study Record Updates
Last Update Posted (Actual)
September 30, 2019
Last Update Submitted That Met QC Criteria
September 26, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TTUIRB2017-247
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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