NCT05344586

Brief Summary

The study will be carried out at the Faculty of Nursing and Physiotherapy of the University of Alcala. The study has been approved by the Animal Research and Experimentation Ethics Committee of the University of Alcalá. Healthy subjects will be recruited and divided into two groups randomly to perform a hamstring stretching program for two months. One group will perform a stretch with neural load and the other without neural load, although both groups will stretch for the same amount of time, repetitions and subjective sensation. Participants will be measured before and after performing their assigned stretch. Then, a new post-stretch measurement will be taken after two months, period during which the subjects will perform the stretching program on their own. Finally, subjects will be asked to quit the stretching program to take a final evaluation measurement after one month of follow-up. The objective will be to evaluate the effects of stretching with and without neural load on hamstring flexibility (main variable), maximum isometric strength and tibial nerve pressure pain threshold.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

April 15, 2022

Completed
7 days until next milestone

Study Start

First participant enrolled

April 22, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 28, 2022

Completed
Last Updated

July 29, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

April 15, 2022

Last Update Submit

July 28, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in hamstring flexibility

    measured with a goniometer. The subject remains in a supine position with both lower limbs extended. One examiner maintains a 90° hip flexion of the lower limb chosen for measurement, while the other examiner passively brings the knee to extension until a greater tissue resistance is noted or a feeling of discomfort is indicated by the subject. The knee extension is measured taking as reference the articular interline, the peroneal malleolus and the greater trochanter. The ankle remains in a relaxed position and the first examiner checks that no pelvic tilts occur while measuring. It is determined whether the subject has hamstring retraction if he scores less than 160º.

    Baseline, 2 months and 3 months after intervention commencement

Secondary Outcomes (1)

  • Changes in maximum isometric hamstring strength

    Baseline, 2 months and 3 months after intervention commencement

Other Outcomes (1)

  • Changes on tibial nerve pressure pain threshold

    Baseline, 2 months and 3 months after intervention commencement

Study Arms (2)

Intervention group

EXPERIMENTAL

Hamstring stretching program with neural load

Other: Hamstring stretching program with neural load

Control group

EXPERIMENTAL

Hamstring stretching program without neural load

Other: Hamstring stretching program without neural load

Interventions

Participants will perform a hamstring stretch with neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, different tension parameters will be added in the following order (the next parameter shall not be introduced until the previous one has been exhausted): ankle dorsiflexion, cervical and craniocervical flexion, and hip flexion.

Intervention group

Participants will perform a hamstring stretch without neural load on their dominant leg. They will stretch five days a week, carrying out two repetitions of one minute each, taking a thirty second break in between. The stretch will be performed in a standing position with their dominant leg on a surface at a mid-thigh height approximately, where their knee is not fully stretched and remains unlocked and their back is in a neutral position. Participants will be encouraged to keep a maximum stretching sensation without feeling any pain. To perform the stretch, tension will be added by flexing their hip, keeping their ankle relaxed and their spine neutral.

Control group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy subjects who do not perform hamstring stretches with neural load in their daily training routine

You may not qualify if:

  • Elite athletes competing or preparing for competition
  • Lower limb surgery
  • Hamstring injury in the last year
  • Neurological, rheumatologic and/or orthopedic pathological history of lower limbs.
  • Other comorbidities

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Juan

Alcalá de Henares, Madrid, 28805, Spain

Location

Study Officials

  • Juan Mínguez

    University of Alcalá, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 15, 2022

First Posted

April 25, 2022

Study Start

April 22, 2022

Primary Completion

July 28, 2022

Study Completion

July 28, 2022

Last Updated

July 29, 2022

Record last verified: 2022-07

Locations