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Topical Eucalyptus Globulus and Mentha x Piperita on Muscle Soreness in Older Adults and the Elderly

Primary Purpose

Muscle Soreness

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mentha x piperita
Eucalyptus globulus
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Muscle Soreness focused on measuring Essential Oils, Muscle Soreness, Mentha x piperita, Eucalyptus globulus

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Subjects 50 years or older with no previous resistance training sessions in the past year
  • Duke Activity Screening Index functional capacity of at least 3.5 metabolic equivalents or greater
  • currently admitted at the Manor Health and Rehabilitation

Exclusion Criteria:

  • history of musculoskeletal injury or weight bearing restrictions to the upper extremities within the past year
  • known adverse reaction or allergy to the essential oils or hypersensitivities to fragrances
  • open upper extremity wounds or history of upper extremity skin grafts

Sites / Locations

  • The Manor Health and Rehabillitation - CentraStateRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Mentha x piperita

Eucalyptus globulus

No intervention

Arm Description

A diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.

A diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.

Each participant will have one extremity that receives no essential oil intervention.

Outcomes

Primary Outcome Measures

Perceived Muscle Soreness
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Perceived Muscle Soreness
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Perceived Muscle Soreness
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness

Secondary Outcome Measures

Full Information

First Posted
April 25, 2021
Last Updated
April 27, 2021
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT04866407
Brief Title
Topical Eucalyptus Globulus and Mentha x Piperita on Muscle Soreness in Older Adults and the Elderly
Official Title
Essential Oils and Delayed Onset Muscle Soreness; The Effects of Topical Mentha x Piperita and Eucalyptus Globulus Oils in the Older Adult and Elderly Population
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 26, 2021 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Subjects over age 50 with no previous resistance training sessions will be recruited at a subacute rehabilitation and long term care facility. Subjects will be asked to perform a series of eccentric upper arm curl exercises under physician supervision in order to induce muscle soreness. Afterwards, topical oil containing a 2% dilution of either eucalyptus or peppermint oil in fractionated coconut oil will be applied to the flexor surface of the proximal non-dominent arm, and plain fractionated coconut oil to the other arm. This will be repeated at 8 hours and 24 hours after exercise. Subjects will be asked to report their perceived level of muscle soreness using a visual analog scale survey 24, 48, and 72 hours after exercise.
Detailed Description
Subjects 50 years old and above with no previous resistance training sessions within the past year will be recruited at a subacute rehabilitation and long-term care facility. A verbal explanation will be provided to the potential subjects by investigators on-site at the facility, including the fact that their care at the facility will not be affected by their decision to participate or not, and if they are interested in proceeding they will be asked to complete a survey regarding the subject's demographics (gender, age, hand dominance) and medical history, ensure there are no hypersensitivities to the oils being used, upper extremity injuries within 1 year, and that they have the functional capacity for exercise of 3.5METs or greater based on the Duke Activity Status Index. If participants pass the screening process they will again be informed of the study and all potential risks/benefits prior to signing an informed consent. Eucalyptus globulus and Mentha x piperita essential oils will be obtained commercially from SunRose Aromatics (Morrill, Maine), and, individually, will be mixed with carrier oil for application. SunRose Aromatics is a recommended supplier from the RJ Buckle Clinical Aromatherapy for Health Professionals course. Fractionated coconut oil will be used as the carrier oil and also obtained from SunRose Aromatics. A 2% oil mixture for topical application will be made with essential oils diluted in fractionated coconut oil per guidelines from the RJ Buckle Clinical Aromatherapy for Health Professionals course recommendations. This mixture will be prepared directly before application of oils. The unmixed oils will be stored in a private room with no windows at room temperature at the Manor Health and Rehabilitation facility (689 W Main St, Freehold, NJ 07728). Participants will be divided randomly into the Mentha x piperita or the Eucalyptus globulus group. A 2% oil mixture for topical application will be made with essential oils from SunRise Aromatics diluted in fractionated coconut oil per guidelines from the RJ Buckle Clinical Aromatherapy for Health Professionals course recommendations. Physician-supervised eccentric exercise of the elbow flexors will be performed based on an adaptation of the method described by Weber. Free weight dumbbells will provide resistance. The subject will be instructed to prolong the extension aspect of the curl to be five seconds long. They will repeat this motion for 10 or more repetitions until exhaustion, either due to the participant feeling they can no longer tolerate the five second eccentric aspect of the exercise or the investigator identifying that their form has faltered. If subjects reach exhaustion after the 10 repetitions minimum, they will rest for 1 minute. If they are unable to complete 10 repetitions at this weight, the resistance will be decreased to the next lowest weight and they will continue until exhaustion. This will continue until subjects reach exhaustion with the lowest resistance weight. Immediately following exercise, the participants will have the respective oil applied topically to their left upper extremity by the investigator. Their right upper extremity will serve as the control and no essential oil will be applied. Investigators will apply the oil without any use of massage technique and to only apply very superficial pressure. This application will be repeated 8 hours after exercise, when DOMS has been known to initiate, and at 24 hours after exercise, when DOMS may begin to peak. Subject outcomes will be based on a self-reported visual analog scale, which has previously been shown to have validity in subjectively quantifying perceived muscle soreness and used in prior studies. These outcomes will be recorded by investigators for both the intervention and control upper extremity at 24, 48, and 72 hours post-exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Soreness
Keywords
Essential Oils, Muscle Soreness, Mentha x piperita, Eucalyptus globulus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mentha x piperita
Arm Type
Experimental
Arm Description
A diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.
Arm Title
Eucalyptus globulus
Arm Type
Experimental
Arm Description
A diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
Each participant will have one extremity that receives no essential oil intervention.
Intervention Type
Other
Intervention Name(s)
Mentha x piperita
Intervention Description
2% solution of Mentha x piperita diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Mentha x piperita' group.
Intervention Type
Other
Intervention Name(s)
Eucalyptus globulus
Intervention Description
2% solution of Eucalyptus globulus diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Eucalyptus globulus' group.
Primary Outcome Measure Information:
Title
Perceived Muscle Soreness
Description
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Time Frame
24 hours after exercise
Title
Perceived Muscle Soreness
Description
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Time Frame
48 hours after exercise
Title
Perceived Muscle Soreness
Description
Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Time Frame
72 hours after exercise

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects 50 years or older with no previous resistance training sessions in the past year Duke Activity Screening Index functional capacity of at least 3.5 metabolic equivalents or greater currently admitted at the Manor Health and Rehabilitation Exclusion Criteria: history of musculoskeletal injury or weight bearing restrictions to the upper extremities within the past year known adverse reaction or allergy to the essential oils or hypersensitivities to fragrances open upper extremity wounds or history of upper extremity skin grafts
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sydney Asselstine, MD
Phone
7322942540
Email
sasselst@centrastate.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeeshan Khan, MD
Organizational Affiliation
Rutgers RWJMS Department of Family Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Manor Health and Rehabillitation - CentraState
City
Freehold
State/Province
New Jersey
ZIP/Postal Code
07728
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sydney Asselstine, MD
Phone
732-294-2540
Email
sasselst@centrastate.edu
First Name & Middle Initial & Last Name & Degree
Zeeshan Khan, MD
Phone
7322942540
Email
zkhan@centrastate.edu
First Name & Middle Initial & Last Name & Degree
Zeeshan Khan, MD
First Name & Middle Initial & Last Name & Degree
Joshua Raymond, MD
First Name & Middle Initial & Last Name & Degree
Sydney Asselstine, MD
First Name & Middle Initial & Last Name & Degree
Anand Shah, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Do not plan to.
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Links:
URL
https://www.acsm.org/blog-detail/acsm-certified-blog/2018/02/01/exercise-preparticipation-screening-removing-barriers-initiating-exercise
Description
ACSM's New Exercise Preparticipation Screening

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Topical Eucalyptus Globulus and Mentha x Piperita on Muscle Soreness in Older Adults and the Elderly

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