Topical Eucalyptus Globulus and Mentha x Piperita on Muscle Soreness in Older Adults and the Elderly
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| ClinicalTrials.gov Identifier: NCT04866407 |
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Recruitment Status :
Recruiting
First Posted : April 29, 2021
Last Update Posted : April 29, 2021
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Muscle Soreness | Other: Mentha x piperita Other: Eucalyptus globulus | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 20 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | April 26, 2021 |
| Estimated Primary Completion Date : | December 2021 |
| Estimated Study Completion Date : | December 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Mentha x piperita
A diluted solution of Mentha x piperita in carrier oil will be applied to the subject's interventional extremity.
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Other: Mentha x piperita
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. |
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Experimental: Eucalyptus globulus
A diluted solution of Eucalyptus globulus in carrier oil will be applied to the subject's interventional extremity.
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Other: Eucalyptus globulus
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. |
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No Intervention: No intervention
Each participant will have one extremity that receives no essential oil intervention.
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- Perceived Muscle Soreness [ Time Frame: 24 hours after exercise ]Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
- Perceived Muscle Soreness [ Time Frame: 48 hours after exercise ]Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
- Perceived Muscle Soreness [ Time Frame: 72 hours after exercise ]Perceived soreness using a visual analog scale rating from '0' to '100'; a higher score indicates more muscle soreness
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 50 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04866407
| Contact: Sydney Asselstine, MD | 7322942540 | sasselst@centrastate.com |
| United States, New Jersey | |
| The Manor Health and Rehabillitation - CentraState | Recruiting |
| Freehold, New Jersey, United States, 07728 | |
| Contact: Sydney Asselstine, MD 732-294-2540 sasselst@centrastate.edu | |
| Contact: Zeeshan Khan, MD 7322942540 zkhan@centrastate.edu | |
| Principal Investigator: Zeeshan Khan, MD | |
| Sub-Investigator: Joshua Raymond, MD | |
| Sub-Investigator: Sydney Asselstine, MD | |
| Sub-Investigator: Anand Shah, MD | |
| Principal Investigator: | Zeeshan Khan, MD | Rutgers RWJMS Department of Family Medicine |
Publications:
| Responsible Party: | Sydney Asselstine, MD, Resident Physician, Rutgers, The State University of New Jersey |
| ClinicalTrials.gov Identifier: | NCT04866407 |
| Other Study ID Numbers: |
Pro2021000112 |
| First Posted: | April 29, 2021 Key Record Dates |
| Last Update Posted: | April 29, 2021 |
| Last Verified: | April 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Do not plan to. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Essential Oils Muscle Soreness Mentha x piperita Eucalyptus globulus |
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Myalgia Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases |
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