NCT06634862

Brief Summary

The aim of this study was to compare the effects of intermittent pneumatic pressure, percussive therapy and graston after a fatigue protocol applied to the leg muscles.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2025

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

3 months

First QC Date

October 8, 2024

Last Update Submit

October 10, 2024

Conditions

Keywords

RecoveryQuadriceps Fatigue ProtocolIntermittent pneumatic pressureSoft Tissue Mobilization TechniquePercussive therapyMuscle FatigueMuscle Tone

Outcome Measures

Primary Outcomes (3)

  • Star Balance Test

    On the floor, 4 strips of adhesive tape, previously cut 2 metres long, will be glued in such a way that they form 45 degree angles between them. The participant will align in the centre of the star and perform the reaching on one leg in anterior, anteromedial, anterolateral, posterior posterolateral, posteromedial, medial and lateral directions. The test will be performed anti-clockwise if the participant's initial leg is right and the participant will reach with the left leg; clockwise if the initial leg is left and the participant will reach with the right leg. During the test, the participant will be asked to keep his/her hands on his/her waist and not to change his/her position throughout the test. Then the participant will be asked to reach to the last point he/she can reach, touch his/her toe to the strip and return to the starting position. Then he/she will be asked to move to the other line in the specified direction and complete a total of 8 lines in this way.

    The balance test will take 10 minutes in total before and after the intervention.

  • Muscle pain measurement with algometer

    Pressure-pain threshold (PPT) will be measured with a hand-held pressure algometer. The participant will be comfortably seated in an ordinary chair with an adjustable seat and backrest and arms resting on a soft support placed on either side of the chair. The chair height and arm rests will be adjusted so that the subject's knees and hips are in 90° flexion. Two sites/muscles will be marked for use in PPT determinations to avoid peripheral sensitisation due to frequent, multiple PPT assessments at the same site. In M. quadriceps femoris, a site 2.5 cm proximal and 2.5 cm distal to the midpoint between the apex patella and groin will be marked bilaterally. The researcher will instruct the participants to press the button on their own as soon as the pressure sensation becomes painful. The rate of pressure increase of the device will be kept between approximately 40-60kPa.

    It will take 30 minutes in total before and after the intervention.

  • Muscle tone measurement with MyotonPRO

    Measurements of bilateral rectus femoris muscles will be taken twice on the same day and time of the week, one week apart.The first measurement will be made without any intervention and the second measurement will be made after the protocol has been implemented.The test lead of the MyotonPRO will be placed on the skin over the area perpendicular to the surface of the muscle belly and the device will then be placed in the measurement position and held steady while the device automatically performs a series of predefined measurements.The device will be used in multiscan mode, where a measurement consists of the average of 10 mechanical touches one second apart. In the control group and in the first measurement of the experimental groups, the measurement will be performed after the participant has rested for 15 minutes after the fatigue protocol as described above.The second measurement in the experimental groups will be performed as described above without resting after the intervention

    It will take 30 minutes in total before and after the intervention.

Study Arms (4)

intermittent pneumatic pressure group

OTHER

Intermittent Pneumatic Compression (IPC) is a mechanical method of applying compression to the limbs and has a number of therapeutic uses. The device consists of a pair of inflatable sleeves wrapped around the leg and an electric pneumatic pump that inflates the sleeves with air, compressing the deep veins and displacing blood proximally. The working principle of IPC is based on passively increasing blood flow by applying external pressure to the extremity, but the exact physiological mechanisms are only partially understood. However, despite its widely recognised use and positive effects on circulatory conditions, the literature on the use of IPC in musculoskeletal treatment is limited. The available evidence has been investigated in several studies, including the efficacy of IPC, its effect on vasodilatory effects in distal skeletal muscle and its effect on serum indices of muscle function, pain and muscle damage. Studies have also reported improvements in exercise duration as wel

Other: Normatec Air Compression

Soft Tissue Mobilization Technique Group

OTHER

The Graston Technique (GT) is a form of instrument-assisted soft tissue mobilisation that uses stainless steel instruments to perform manual therapy on soft tissues. It is widely used by clinicians to treat various soft tissue disorders. Research has reported that it effectively promotes the inhibition of adhesion of treated tissues and collagen synthesis. Furthermore, the graston technique has been used to manage pain and range of motion limitations caused by scar tissue and musculoskeletal injuries. Overall, the graston technique has been studied in a variety of contexts and has demonstrated potential effects on range of motion, pain relief and musculoskeletal conditions. Some studies reported direct effects on specific outcomes, while others emphasised its potential when combined with other therapeutic interventions. These findings contribute to the understanding of the graston technique as a modality for soft tissue mobilisation and musculoskeletal disorders in the field of physio

Other: Soft Tissue Mobilization

Percussive Therapy Group

OTHER

Percussive therapy has gained popularity in recent years as a potential intervention to alleviate muscle soreness and fatigue after exercise. This therapy involves the use of a mechanical system to provide percussive massage and its effectiveness in promoting recovery and reducing muscle soreness has been a topic of interest in the field of sports medicine and rehabilitation. Several studies have investigated the acute effects of percussive therapy on muscle recovery and pain, aiming to understand its potential benefits for athletes and individuals engaged in physical activities. Furthermore, the use of percussive therapy with resistance training has been shown to have acute effects on movement speed, suggesting the potential to influence exercise performance and recovery. These findings contribute to the understanding of how percussive therapy can influence muscle function and recovery processes. In the context of pain management, exercise therapy is advocated as an effective treatm

Other: Percussive therapy

control group

NO INTERVENTION

In the control group, quadriceps fatigue protocol was applied, measurements were taken on two separate days and no intervention was made.

Interventions

Intermittent pneumatic pressure has been used in other studies, usually for deep vein thrombosis and vascular disorders. In this way, it has not been compared with other recovery interventions for post-exercise recovery applications.

intermittent pneumatic pressure group

The soft tissue mobilisation technique has been investigated in other studies in terms of its effect on soft tissue and its role recovery. In this way, there is no comparison with other recovery interventions for post-exercise recovery applications.

Soft Tissue Mobilization Technique Group

Percussive therapy has been investigated in device research and athlete health. In this way, it has not been compared with other recovery interventions for post-exercise recovery applications.

Percussive Therapy Group

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • To be between 25-45 years old.
  • Not having any chronic disease.
  • Not doing active sports for at least 6 months.
  • Not having any previously diagnosed lower extremity pathology.
  • Not having a chronic lower extremity problem and not having a major trauma (fracture, anterior cruciate ligament injury, etc.).
  • Not having any cognitive problem that prevents them from following and adapting to a specific exercise programme.
  • No visual, vestibular and neurological disorders.

You may not qualify if:

  • Having a chronic disease.
  • Any musculoskeletal problem in the lower extremities.
  • Use of sedative medication due to chronic disease (rheumatism, lung and/or heart etc.)
  • Regular use of painkillers, muscle relaxants or anti-inflammatory drugs.
  • Any history of surgery on the lower extremity.
  • Any history of pain in the lower extremity during the fatigue protocol.
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Okan University

Istanbul, Tuzla, 34959, Turkey (Türkiye)

Location

Related Publications (2)

  • Stedge HL, Armstrong K. The Effects of Intermittent Pneumatic Compression on the Reduction of Exercise-Induced Muscle Damage in Endurance Athletes: A Critically Appraised Topic. J Sport Rehabil. 2021 Jan 8;30(4):668-671. doi: 10.1123/jsr.2020-0364.

    PMID: 33418535BACKGROUND
  • Machado AF, Ferreira PH, Micheletti JK, de Almeida AC, Lemes IR, Vanderlei FM, Netto Junior J, Pastre CM. Can Water Temperature and Immersion Time Influence the Effect of Cold Water Immersion on Muscle Soreness? A Systematic Review and Meta-Analysis. Sports Med. 2016 Apr;46(4):503-14. doi: 10.1007/s40279-015-0431-7.

    PMID: 26581833BACKGROUND

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Four groups, together with a control group with no intervention. One group will receive pneumatic pressure treatment, one group will receive soft tissue mobilisation (graston) treatment and another group will receive percussive therapy treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master of Science, Principal Investigator

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

December 2, 2024

Primary Completion

March 16, 2025

Study Completion

May 18, 2025

Last Updated

October 15, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

When the study is finalised, researchers who want to use my data can send me an e-mail and use my data.

Locations