The Dosing of Aerobic Exercise Therapy on Experimentally-induced Pain in Healthy Female Participants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Intervention Effects on Constant Heat Pain Unpleasantness
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between age 18-40
- •Normal BMI (18.5-25.0)
- •Heart Rate (HR) 60-100 bmp
- •BP less than or equal to 140/90
排除标准
- •Age <18 or >40 years
- •Cardiac, respiratory, neurological or musculoskeletal disease
- •Chronic pain condition
- •BMI ≥ 25.1 or ≤ 18.4
- •Regular participation in high intensity athletic/sporting activities
- •Anxiety or depression disorders
- •Tape allergy
- •Currently pregnant
结局指标
主要结局
Intervention Effects on Constant Heat Pain Unpleasantness
时间窗: baseline and 24 hrs-post final intervention session
Subjects' constant heat pain unpleasantness rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Mechanical Sensitivity Threshold
时间窗: baseline and 24 hrs-post final intervention session
Subjects' cutaneous mechanical sensitivity threshold will be examined using standard monofilaments that apply a force of 0.008g, 0.02g, 0.04g, 0.07g, 0.16g, 0.4g, 0.6g and 1.0g to the forearm and calf. Percent Baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline). A filament of different weight is applied to the skin to look at the threshold of response.
Intervention Effects on Constant Heat Pain Intensity
时间窗: baseline and 24 hrs-post final intervention session
Subjects' constant heat pain intensity rating will be assessed using a (45 degree Celsius, 3cm x 5cm heating block applied to the forearm and calf for 3 seconds). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Sensitivity
时间窗: baseline and 24 hrs-post final intervention session
Subjects' radiant heat sensitivity will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 60 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "sensitivity threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Pressure Pain Threshold
时间窗: baseline and 24 hrs-post final intervention session
Subjects' pressure pain threshold will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied at constant ramping pressure until participant defined cutoff in kg at "pain threshold"). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Intensity
时间窗: baseline and 24 hrs-post final intervention session
Subjects' constant pressure pain intensity rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the intensity of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "no pain" and "10" represents "the worst pain imaginable" (0=minimum score, 10 maximum score). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Radiant Heat Pain
时间窗: baseline and 24 hrs-post final intervention session
Subjects' radiant heat pain threshold will be assessed using a temperature ramp from 30 degrees Celsius to 50 degrees Celsius over 20 seconds with participant defined cutoff in temperature (degrees Celsius) reading at their "pain threshold" to the thermal stimulus (IITC Thermal Stimulus Apparatus with custom heated glass). This will be assessed on the forearm and calf. Percent baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
Intervention Effects on Constant Pressure Pain Unpleasantness
时间窗: baseline and 24 hrs-post final intervention session
Subjects' constant pressure pain unpleasantness rating will be assessed using a pressure algometer (Wagner Instruments; 1cm round probe applied for 2 seconds at participant defined threshold). Following the stimulus, subjects will rate the unpleasantness of the pain associated with the stimulus using a visual analog scale numbered at 0 and 10, where "0" represents "not unpleasant" and "10" represents "the most unpleasant sensation imaginable" (0=minimum score, 10 maximum score).This will be assessed on the forearm and calf. Percent change from baseline to 24 hrs post-intervention will then be calculated (100\*Value at 24 hours/Value at Baseline).
次要结局
- Borg Rate of Perceived Exertion (RPE)(days 1, 3, & 5 at start and end of each exercise session)
- Heart Rate(days 1, 3, & 5 at start and end of each exercise session)
研究者
Benedict Kolber
Associate Professor
Duquesne University