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Exercise Dosing for Pain in Healthy Participants

D

Duquesne University

Status

Completed

Conditions

Pain

Treatments

Behavioral: Control
Behavioral: Walking Exercise

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03642938
2014-04-22
UL1TR001857 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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).

Enrollment

41 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 4 patient groups

Low Dose Exercise
Experimental group
Description:
The Low Dose Exercise group will perform treadmill walking exercise, three times per week for one week.
Treatment:
Behavioral: Walking Exercise
Moderate Dose Exercise
Experimental group
Description:
The Moderate Dose Exercise group will perform treadmill walking exercise, five times per week for one week.
Treatment:
Behavioral: Walking Exercise
High Dose Exercise
Experimental group
Description:
The High Dose Exercise group will perform treadmill walking exercise, ten times per week for one week.
Treatment:
Behavioral: Walking Exercise
Control
Sham Comparator group
Description:
The Control group will perform quiet rest, three times per week for one week.
Treatment:
Behavioral: Control

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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