NCT04632979

Brief Summary

This study will look to evaluate the feasibility of a backwards downhill running program as an option for the treatment of Achilles tendinopathy in runners. It is known that exercise on the Achilles tendon during elongation (eccentric exercise) improves tendon function after injury. However, during recovery, the patient is required to stop tendon-loading activities such as jumps and sprints. Therefore, during recovery, athletes decline in physical fitness. Backward running on a negative slope can achieve a biomechanical load similar to eccentric exercise without decreasing physical fitness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 3, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 17, 2020

Completed
Last Updated

November 17, 2020

Status Verified

September 1, 2019

Enrollment Period

6 months

First QC Date

November 9, 2020

Last Update Submit

November 16, 2020

Conditions

Keywords

Achilles tendinopathybackward runningexerciserunning overuse injury

Outcome Measures

Primary Outcomes (12)

  • VISA-A questionnaire

    Subjective questionnaire specific for Achilles tendinopathy

    baseline

  • VISA-A questionnaire

    Subjective questionnaire specific for Achilles tendinopathy

    two weeks

  • VISA-A questionnaire

    Subjective questionnaire specific for Achilles tendinopathy

    three weeks

  • VISA-A questionnaire

    Subjective questionnaire specific for Achilles tendinopathy

    five weeks

  • Number of single legged heel raises from a flat surface before the onset of pain

    Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters

    baseline

  • Number of single legged heel raises from a flat surface before the onset of pain

    Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters

    two weeks

  • Number of single legged heel raises from a flat surface before the onset of pain

    Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters

    three weeks

  • Number of single legged heel raises from a flat surface before the onset of pain

    Heel raise height will be defined by a pretest of one maximum single legged heel raise assessed by a measuring tape in centimeters

    five weeks

  • Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill

    Forward running on treadmill until the onset of relevant pain

    baseline

  • Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill

    Forward running on treadmill until the onset of relevant pain

    three weeks

  • Onset of relevant Achilles tendon pain (measured in seconds) during Forward running at a self-selected comfortable pace on a treadmill

    Forward running on treadmill until the onset of relevant pain

    five weeks

  • Compliance

    Treatment sessions will be calculated upon the patient's completion of the full treatment protocol for that specific session. Inclusion will be terminated upon lack of fulfilling the treatment protocol or failing to complete a total of at least eight sessions.

    five weeks

Study Arms (1)

Backward runners

EXPERIMENTAL

Training protocol patients

Procedure: Backwards running on a Treadmil with a negative slope

Interventions

Running backward on a treadmill with a negative slope

Backward runners

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Distinct tenderness of Achilles tendon with no pain in the neighboring structures.
  • Nontraumatic diffuse pain in the posterior calf with local tenderness in the Achilles tendon.
  • A history of running for at least one session a week in the past three months.
  • Age \> 18 and \< 70

You may not qualify if:

  • Achilles pain longer than six months.
  • Patients with an additional lower extremity injury unable to bear full weight on the limb.
  • Patients who are currently receiving physical therapy for Achilles tendinopathy, have received a steroid injection into the tendon in the three months prior, or underwent Achilles tendon surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meuhedet Health Services

Jerusalem, Israel

Location

Related Publications (3)

  • Braunstein M, Baumbach SF, Herterich V, Bocker W, Polzer H. [Acute achilles tendon rupture : State of the art]. Unfallchirurg. 2017 Dec;120(12):1007-1014. doi: 10.1007/s00113-017-0420-4. German.

    PMID: 29038897BACKGROUND
  • Bovend'Eerdt TJ, Botell RE, Wade DT. Writing SMART rehabilitation goals and achieving goal attainment scaling: a practical guide. Clin Rehabil. 2009 Apr;23(4):352-61. doi: 10.1177/0269215508101741. Epub 2009 Feb 23.

    PMID: 19237435BACKGROUND
  • Billingham SA, Whitehead AL, Julious SA. An audit of sample sizes for pilot and feasibility trials being undertaken in the United Kingdom registered in the United Kingdom Clinical Research Network database. BMC Med Res Methodol. 2013 Aug 20;13:104. doi: 10.1186/1471-2288-13-104.

    PMID: 23961782BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Shmuel Springer, prof

    Ariel University, Physical Therapy Department

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 17, 2020

Study Start

October 3, 2019

Primary Completion

April 1, 2020

Study Completion

May 1, 2020

Last Updated

November 17, 2020

Record last verified: 2019-09

Data Sharing

IPD Sharing
Will not share

Locations