NCT02543008

Brief Summary

Comparison of the effects of physical activity (treadmill running) plus thoracic mobilization, physical activity only or a placebo intervention (only manual contact thoracic mobilization), on heart rate variability and pressure pain threshold.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2015

Shorter than P25 for not_applicable healthy

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 7, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

2 months

First QC Date

September 2, 2015

Last Update Submit

February 13, 2017

Conditions

Keywords

Asymptomatic individuals

Outcome Measures

Primary Outcomes (1)

  • Heart rate variability

    Change from baseline, immediately after, and 15 minutes after the intervention.

Secondary Outcomes (1)

  • Pressure pain threshold

    Change from baseline, mimediately after, and 15 minutes after the intervention.

Study Arms (3)

Physical activity plus thoracic mobilization

EXPERIMENTAL

Subjects randomly allocated to this arm will be submitted to a 10 minutes anaerobic exercise (2 minutes warming up, 5 minutes of 75% to 85% maximal heat rate, 3 minutes slowdown), followed by 5 minutes of passive intervertebral thoracic mobilization (3 sets of 1 minute, grade III, and 1 minute rest between each set).

Procedure: Physical activity plus thoracic mobilization

Physical activity

ACTIVE COMPARATOR

Subjects allocated to this arm will be submitted to the same anaerobic exercise protocol, without the thoracic mobilization.

Procedure: Physical activity

Placebo

PLACEBO COMPARATOR

Subjects in this group will be conducted to a placebo thoracic mobilization, without anaerobic exercise protocol. The investigator will apply only a manual contact, to mimic the genuine thoracic mobilization. The same 5 minutes period will be respected, and the same position of therapist and subject.

Procedure: Placebo

Interventions

Information already included in arm/group descriptions.

Physical activity plus thoracic mobilization

Information already included in arm/group descriptions.

Physical activity
PlaceboPROCEDURE

Information already included in arm/group descriptions.

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Asymptomatic subjects
  • Sedentary

You may not qualify if:

  • Spinal pain
  • Historic of trauma/surgery to the spine
  • Diabetes
  • Hypo/hyperthyroidism
  • Alcoholic
  • Smoker
  • Hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal de Ciencias da Saude

Porto Alegre, Rio Grande do Sul, 90160240, Brazil

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pt, MSc

Study Record Dates

First Submitted

September 2, 2015

First Posted

September 7, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations