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Completed

NCT Number: NCT03173755

Pain Discomfort Enjoyment Levels During Moderate Exercise

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Texas Tech University - Department of Nutritional Sciences

Lubbock, Texas, 79409, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

Secondary outcomes

  1. 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>.)

  2. 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>.)

  3. 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).

Sponsors and collaborators

Lead sponsor

Texas Tech University

Other

Registry information

Official study title

Relationships of Pain, Discomfort and Enjoyment During Exercise to Weight Status and Diet Quality.

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jun 2, 2017
Registry last updated
Sep 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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