NCT04161300

Brief Summary

The main objective of the present study was to evaluate whether FR massage is effective in improving dynamic balance, flexibility and dynamic strength after intense exercise recovery compared to OMPT protocol or a control group. The present study was a randomized controlled trial. Amateur athletes will be recruited from two athletic clubs. Participants will be randomizing and allocating into three non-balanced groups through a computer software by an external assistant who will be blinding to the study objectives: FR group (n = 18), OMPT group (n = 15) and control group (CG) (n = 14). The intervention period will be lasting one day (1 session). Participant assessment will be perform twice: prior to the study (pre-intervention) and immediately after finishing the intervention (post-intervention). Interventions: FR group. FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes; OMPT group. Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; The total duration will be approximately 10-15 minutes.; CG. The CG did not receive any intervention. Outcomes will be Lumbar flexibility, Hip flexion, Dynamic balance, Standing Jump and Impression of Change.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

November 8, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2020

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

2 months

First QC Date

November 8, 2019

Last Update Submit

February 25, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Dynamic balance

    Dynamic balance using the Star Excursion Balance Test (SEBT). The SEBT is a dynamic test that requires strength, flexibility, and proprioception. The goal of the SEBT is to maintain single-leg stance while reaching as far as possible with the contralateral leg. Subjects are instructed to stand with both feet positioned inside the boundaries of the starting box. The test initiates when the subject begins to reach in one of the four diagonal directions.

    1 day

Secondary Outcomes (4)

  • Perception of Change

    1 day

  • Lumbar flexibility

    1 day

  • Hip flexion

    1 day

  • Standing Jump

    1 day

Study Arms (3)

Foam Rolling Group (FR)

ACTIVE COMPARATOR
Other: Foam Rolling (FR)

Orthopaedic Manual Physical Therapy Group (OMPT)

ACTIVE COMPARATOR
Other: Orthopaedic Manual Physical Therapy Group (OMPT)

Control Group (CG)

OTHER
Other: Control Group (CG)

Interventions

FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes.

Foam Rolling Group (FR)

The CG did not receive any intervention.

Control Group (CG)

Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; b) Hip joint decompression, performing 25 repetitions c) Hip rotator stretch with hip and knee flexion, 15 repetitions; d) Femorotibial decompression, 25 reps. e) Quadriceps femoral muscle compression and traction, 25 repetitions; f) Opening of the internal and external femorotibial interline, 15 repetition; g) Ankle decompression, 3 repetitions; h) Posteroanterior and anteroposterior mobilization of head and base of fibula, 25 repetitions. The total duration will be approximately 10-15 minutes.

Orthopaedic Manual Physical Therapy Group (OMPT)

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • male and female amateur athletes

You may not qualify if:

  • previous surgery of the locomotor system in lower limbs
  • musculoskeletal injuries in any part of the body that prevent practicing sports understanding or communication difficulties
  • insufficient fluency in the Spanish language to follow measurement instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gemma v. Espí López

Valencia, 46010, Spain

Location

Related Publications (1)

  • Espi-Lopez GV, Ruescas-Nicolau MA, Castellet-Garcia M, Suso-Marti L, Cuenca-Martinez F, Marques-Sule E. Effectiveness of Foam Rolling vs. Manual Therapy in Postexercise Recovery Interventions for Athletes: A Randomized Controlled Trial. J Strength Cond Res. 2023 Jun 1;37(6):e361-e368. doi: 10.1519/JSC.0000000000004383. Epub 2022 Dec 19.

MeSH Terms

Conditions

Athletic Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Gemma V Espí-López, Dr

    Faculty of Physiotherapy. University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 13, 2019

Study Start

November 15, 2019

Primary Completion

January 15, 2020

Study Completion

February 18, 2020

Last Updated

March 2, 2021

Record last verified: 2021-02

Locations