Clinical trial NCT03642938: Exercise Dosing for Pain in Healthy Participants
Official title: The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Exercise
Dose
Analgesia
Lead sponsor: Duquesne University
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2018-08-22
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pseudo-randomized controlled trial
Primary purpose: TREATMENT

Brief summary: In this study investigators will examine the effect of dose related to exercise therapy for pain in healthy adult humans. An acute pain model will be employed to study the effect of exercise dose on pain. Acute pain models are currently used to study pain (both acute and chronic) in human samples as there is currently no chronic pain model.

Detailed description: This study is designed as a randomized controlled trial with repeated measures. The effect of exercise dose on pain: subjects will be randomly assigned to one of four exercise groups: 1.) no exercise (control); 2.) low dose exercise (3x/week); 3.) moderate dose exercise (5x/week). 4.) high dose exercise (10x/week).

Eligibility criteria: Inclusion Criteria:

1. Between age 18-40
2. Normal BMI (18.5-25.0)
3. Heart Rate (HR) 60-100 bmp
4. BP less than or equal to 140/90

Exclusion Criteria:

1. Age \<18 or \>40 years
2. Cardiac, respiratory, neurological or musculoskeletal disease
3. Acute pain
4. Chronic pain condition
5. Diabetes
6. BMI ≥ 25.1 or ≤ 18.4
7. Regular participation in high intensity athletic/sporting activities
8. Sedentary
9. Anxiety or depression disorders
10. Tape allergy
11. Currently pregnant

Primary outcomes:
measure: Intervention Effects on Mechanical Sensitivity Threshold
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Constant Heat Pain Intensity
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Constant Heat Pain Unpleasantness
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Radiant Heat Sensitivity
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Radiant Heat Pain
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Pressure Pain Threshold
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Constant Pressure Pain Intensity
timeFrame: baseline and 24 hrs-post final intervention session
measure: Intervention Effects on Constant Pressure Pain Unpleasantness
timeFrame: baseline and 24 hrs-post final intervention session
Secondary outcomes:
measure: Heart Rate
timeFrame: days 1, 3, & 5 at start and end of each exercise session
measure: Borg Rate of Perceived Exertion (RPE)
timeFrame: days 1, 3, & 5 at start and end of each exercise session
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Duquesne University
state: Pennsylvania
Study officials:
affiliation: Duquesne University
name: Kimberly A Szucs, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duquesne University
name: Amy L Phelps, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Duquesne University
name: Matthew C Kostek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Polaski AM, Phelps AL, Szucs KA, Ramsey AM, Kostek MC, Kolber BJ. The dosing of aerobic exercise therapy on experimentally-induced pain in healthy female participants. Sci Rep. 2019 Oct 16;9(1):14842. doi: 10.1038/s41598-019-51247-0.