Clinical trial NCT04866407: 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
Overall status: TERMINATED
Phase: NA
Conditions: Muscle Soreness
Keywords: Essential Oils
Muscle Soreness
Mentha x piperita
Eucalyptus globulus
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-04-29
Enrollment: 8
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Perceived Muscle Soreness
timeFrame: 24 hours after exercise
measure: Perceived Muscle Soreness
timeFrame: 48 hours after exercise
measure: Perceived Muscle Soreness
timeFrame: 72 hours after exercise
Secondary outcomes:
Other outcomes:
Locations:
city: Freehold
country: United States
facility: The Manor Health and Rehabillitation - CentraState
state: New Jersey
Study officials:
affiliation: Rutgers RWJMS Department of Family Medicine
name: Zeeshan Khan, MD
role: PRINCIPAL_INVESTIGATOR
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