NCT04859140

Brief Summary

The present double-blinded randomized controlled design aims at comparing the effects of a full-body manual massage and foam rolling intervention. Sixty-five healthy individuals were randomly allocated to foam rolling, manual massage or a control intervention consisting in an autogenic relaxation routine.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2021

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

Study Start

First participant enrolled

April 1, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2021

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

April 16, 2021

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

Same day

First QC Date

April 16, 2021

Last Update Submit

April 21, 2021

Conditions

Keywords

electroencephalographyelectrodermal activityflexibilityalertness

Outcome Measures

Primary Outcomes (5)

  • Change in range of motion measures from standardized flexibility tests

    Lower back and hamstring flexibility index from sit-and-reach and toe touch tests

    Pretest and an immediate posttest after the intervention

  • Resting-state electroencephalography

    Power of alpha and beta neural oscillations

    Pretest and an immediate posttest after the intervention

  • Changes in subjective scores (self-reports on numeric rating scales)

    Perceived anxiety and physical sensations (muscle pain, warmth and relaxation) on a numeric rating scale of 10 cm (0: "Complete absence of anxiety/muscle pain/muscle warmth/muscle relaxation"; 10: "Maximal possible levels of anxiety/muscle pain/muscle warmth/muscle relaxation")

    Pretest and an immediate posttest after the intervention

  • Changes in mental calculation performances

    Iterated substractions for 2 minutes

    Pretest and an immediate posttest after the intervention

  • Changes in physiological arousal

    Skin conductance during resting state periods

    Pretest and an immediate posttest after the intervention

Study Arms (3)

Foam rolling

EXPERIMENTAL

The foam rolling routine consisted in unilateral exercises alternatively performed on both legs and bilateral exercises on lower and back muscles. All participants started with the feet in a standing up position with a lacrosse ball. Then, participants performed on the ground the foam rolling exercises with the foam roller targeting leg and back muscles.

Other: Psychometric ratings (Likert-scale)Behavioral: Range of motion measuresBehavioral: Mental calculation taskDevice: Resting-state electroencephalographyDevice: Resting-state galvanic skin resistance measures

Manual massage

EXPERIMENTAL

Participants in the manual massage group received manual massage by a professional physiotherapist who was blinded to the purpose of the experiment (20 years of registered practice). Participants were lying in the prone position on a massage table. To facilitate the physiotherapist's maneuvers, massage oil was used. The manual massage protocol reproduced several features of the foam rolling intervention, i.e., order of the areas massaged, massage time per muscles and total duration of the session.

Other: Psychometric ratings (Likert-scale)Behavioral: Range of motion measuresBehavioral: Mental calculation taskDevice: Resting-state electroencephalographyDevice: Resting-state galvanic skin resistance measures

Autogenic relaxation

ACTIVE COMPARATOR

Participants in the relaxation group listened to a 16 min relaxation audio tape, based on the autogenic training method. Participants were lying on the massage table in supine position, wearing headphones. During this desensitization-relaxation technique, they were guided to visualize bodily perceptions of heaviness and warmth in their arms, thorax and legs. To facilitate concentration, participants were left alone in a dark room.

Other: Psychometric ratings (Likert-scale)Behavioral: Range of motion measuresBehavioral: Mental calculation taskDevice: Resting-state electroencephalographyDevice: Resting-state galvanic skin resistance measures

Interventions

Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)

Autogenic relaxationFoam rollingManual massage

Sit-and-reach and toe touch tests

Autogenic relaxationFoam rollingManual massage

Iterated substractions (for 2 minutes)

Autogenic relaxationFoam rollingManual massage

Alpha and beta oscillation power (4 minutes recordings)

Autogenic relaxationFoam rollingManual massage

Skin conductance during the resting state period

Autogenic relaxationFoam rollingManual massage

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Regular practice of foam rolling (10 min routines, 2-3 times per week over the past 6 months)

You may not qualify if:

  • Chronic medical conditions including functional limitations that might affect proprioception and/or pain perception

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Claude Bernard Lyon 1

Villeurbanne, 69622, France

Location

MeSH Terms

Conditions

Health BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Allocation concealment
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Three independent groups, two measurement points
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 26, 2021

Study Start

April 1, 2021

Primary Completion

April 1, 2021

Study Completion

April 1, 2021

Last Updated

April 26, 2021

Record last verified: 2021-04

Locations