Trial Outcomes & Findings for Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles (NCT NCT03442933)

Results Overview

This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

40 participants

Primary outcome timeframe

Change between Baseline and 3 hours

Results posted on

2019-08-12

Participant Flow

In total, 40 participants were randomly assigned to their Arm/Group, in which the intervention was administered in 2 different sequences of intervention: 1) Road Cycling first, then Mountain Biking; and 2) Mountain Biking first, then Road Cycling.

They were required to attend on 2 different occasions to our installation, both spaced a week apart as washout.

Participant milestones

Participant milestones
Measure	Road Cycling First, Then Mountain Biking They will be examined before and after 3 hours road cycling time trial (TT). And after 7 days washout, they will be examined before and after 3 hours mountain biking TT.	Mountain Biking First, Then Road Cycling. They will be examined before and after 3 hours mountain biking time trial (TT). And after 7 days washout, they will be examined before and after 3 hours road cycling TT.
Overall Study STARTED	20	20
Overall Study COMPLETED	20	20
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of the Acute Effect of Cycling Practice in Lumbar and Thigh Muscles

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=40 Participants Regardless of the Arm/Group in which the participants were initially assigned, all participants received all interventions. Therefore they are represented combined into one single Arm/Group.
Age, Continuous	35 years STANDARD_DEVIATION 8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	40 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	40 Participants n=5 Participants
Region of Enrollment Spain	40 Participants n=5 Participants
Height	177 cm STANDARD_DEVIATION 7 • n=5 Participants
Weight	74.4 kg STANDARD_DEVIATION 8.9 • n=5 Participants
Body Mass Index (BMI)	23.9 kg/m^2 STANDARD_DEVIATION 1.9 • n=5 Participants

PRIMARY outcome

Timeframe: Change between Baseline and 3 hours

Population: Amateur males from mixed cycling modalities with an experience in the practice of cycling greater than 3 years

This variable records the intensity pain perceived on the lumbar region (LBPP) by using a 0 to 10 numeric pain-rating scale (NPRS). This is an 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain). The LBPP was measured before and after completing each time trial.

Outcome measures

Outcome measures
Measure	Road Cycling First, Then Mountain Biking n=20 Participants First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.	Mountain Biking First, Then Road Cycling n=20 Participants First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.
Low Back Pain Perception (LBPP) Baseline	1 units on a scale Standard Deviation 1.4	0.8 units on a scale Standard Deviation 1.2
Low Back Pain Perception (LBPP) After 3 hours	3.4 units on a scale Standard Deviation 2.2	3.3 units on a scale Standard Deviation 2

PRIMARY outcome

Timeframe: Baseline and after 3 hours

The variable Dm is given by the radial displacement of the muscular belly in a transverse plane, expressed in milimeters (mm) and depends on muscle tone or stiffness. A low Dm is related to a high muscle tone or an excess of stiffness, while a high Dm value indicates a lack of muscle tone or stiffness defect.

Outcome measures

Outcome measures
Measure	Road Cycling First, Then Mountain Biking n=20 Participants First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.	Mountain Biking First, Then Road Cycling n=20 Participants First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.
Maximal Radial Displacement (Dm) Baseline	7.6 mm Standard Deviation 2.1	7.2 mm Standard Deviation 2.2
Maximal Radial Displacement (Dm) After 3 hours	9 mm Standard Deviation 2.1	8.8 mm Standard Deviation 2.3

PRIMARY outcome

Timeframe: Baseline and after 3 hours

Measured from 0 to 10kg/cm2 with a manual mechanical algometer (FDK/FDN, Wagner Instruments, 1217 Greenwich, CT 06836), which has bilaterally shown an excellent reliability, reproducibility, and sensitivity on the lumbar erector spinae muscles.

Outcome measures

Outcome measures
Measure	Road Cycling First, Then Mountain Biking n=20 Participants First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.	Mountain Biking First, Then Road Cycling n=20 Participants First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.
Pressure Pain Threshold (PPT) Baseline	5 kg/cm^2 Standard Deviation 2	4.7 kg/cm^2 Standard Deviation 1.9
Pressure Pain Threshold (PPT) After 3 hours	4.6 kg/cm^2 Standard Deviation 1.9	4.5 kg/cm^2 Standard Deviation 1.8

SECONDARY outcome

Timeframe: Baseline

The functional disability caused by LBP through the Roland-Morris Questionnaire (RMQ). The score ranges from 0 to 24, with 0 indicating no disability and 24 maximum disability.

Outcome measures

Outcome measures
Measure	Road Cycling First, Then Mountain Biking n=40 Participants First Intervention (3 hours: Road cycling), followed by a 7 days washout, and the second Intervention (3 hours: Mountain Biking). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.	Mountain Biking First, Then Road Cycling First Intervention (3 hours: Mountain Biking), followed by a 7 days washout, and the second Intervention (3 hours: Road cycling). 3 hours Road Cycling Time Trial: The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic. 3 hours Mountain Biking Time Trial: The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.
Roland-Morris Questionnaire (RMQ) Score of 5	1 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 6	3 Participants	—
Roland-Morris Questionnaire (RMQ) Score of more than 6	0 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 0	22 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 1	9 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 2	3 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 3	2 Participants	—
Roland-Morris Questionnaire (RMQ) Score of 4	0 Participants	—

Adverse Events

Road Cycling First, Then Mountain Biking

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Mountain Biking First, Then Road Cycling

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gerson Garrosa Martín

Universidad Europea de Madrid

Phone: +34 663 294 774

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place