Pain Discomfort Enjoyment Levels During Moderate Exercise

NCT ID: NCT03173755

Last Updated: 2019-09-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 127 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-29
• Study Completion Date: 2019-05-31

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.

Conditions

Overweight and Obesity

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

People with normal weight

No interventions assigned to this group

people with overweight and obesity

No interventions assigned to this group

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Texas Tech University

OTHER

Sponsor Role: lead

Responsible Party

Martin Binks

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Martin Binks, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University - Department of Nutritional Sciences

Locations

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, United States

Countries

United States

Other Identifiers

TTUIRB2017-247

Identifier Type: -

Identifier Source: org_study_id