Clinical trial NCT03173755: Pain Discomfort Enjoyment Levels During Moderate Exercise
Official title: Relationships of Pain, Discomfort and Enjoyment During Exercise to Weight Status and Diet Quality.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Overweight and Obesity
Lead sponsor: Texas Tech University
Sponsor class: OTHER
First posted: 2017-06-02
Enrollment: 127
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study will recruit participants from Lubbock Texas Community and surrounding regions.

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to BMI.
timeFrame: Baseline
measure: Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to BMI.
timeFrame: Baseline
measure: Comparison of physical activity-induced pain (Subjective Pain Rating Scale) according to BMI.
timeFrame: minute zero through minute 42 of single exercise testing session (pre- post- session)
Secondary outcomes:
measure: Comparison of self-report measurement of pain (Short Form McGill Pain Questionnaire) according to diet quality index.
timeFrame: Baseline
measure: Comparison of self-report measurement of pain (Subjective Pain Rating Scale) according to diet quality index.
timeFrame: Baseline
measure: Comparison of objectively measured pain tolerance (Dolorimetry) according to BMI.
timeFrame: Baseline
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Texas Tech University - Department of Nutritional Sciences
state: Texas
Study officials:
affiliation: Texas Tech University - Department of Nutritional Sciences
name: Martin Binks, PhD
role: PRINCIPAL_INVESTIGATOR
References: