Feasibility of an Early Progressive Strength Exercise Programme for Acute Achilles Tendon Rupture

NCT ID: NCT04121377

Last Updated: 2020-10-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-11
• Study Completion Date: 2020-04-30

Brief Summary

The aim of this study is to investigate the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. The outcomes will concern the patient's acceptability of the intervention, adherence to the intervention and safety of the healing tendon.

Detailed Description

Regardless of choice of either surgical or non-surgical treatment, long-term muscular deficits and a decreased function after Achilles tendon rupture is found up to 10 years later. The majority of the patients are of working age and a deficit in physical performance will have impact on returning to work and sports.

There has been promising results in treatments using early functional rehabilitation during the first eight weeks of treatment after both surgical and non-surgical treatment, but few studies has examined the effect of the exercises on its own. In general, descriptions of the exercise programs are lacking important information such as type, time of application, frequency, intensity and progression of the exercises.

The primary aim is to test the feasibility of an early progressive exercise program for patients with Achilles tendon rupture treated non-surgically. Feasibility in this study will be defined as successful patient acceptability and compliance of the exercise intervention.

Conditions

Achilles Tendon Rupture

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Resistance exercise program

Early resistance exercise sessions and home program

Group Type: EXPERIMENTAL

Resistance training

Intervention Type: OTHER

Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.

Interventions

Resistance training

Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being "easy" to "hard" (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Acute Achilles tendon rupture treated non-surgically
• Diagnosed and treatment initiated within 3 days of injury
• Age 18-65, able and willing to participate in the intervention
• Able to speak and understand Danish

Exclusion Criteria

• Insertional Achilles tendon rupture on calcaneus or rupture in the musculo-tendinous junction of the triceps surae
• Previous Achilles tendon rupture or other conditions in either leg causing lower leg disability (pain, deficits in strength or range of movement)
• Treated with Fluoroquinolones or Corticosteroids within the last 6 months
• Diabetes
• Severe medical illness: ASA score higher than or equal to 3. (ASA: American Society of Anesthesiologists physical status classification system)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aalborg University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Marianne Christensen

PT, PHD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marianne Christensen, MHSc

Role: PRINCIPAL_INVESTIGATOR

Physiotherapy and Occupational Therapy, Aalborg University Hospital

Locations

Physiotherapy and Occupational Therapy, Aalborg University Hospital

Aalborg, , Denmark

Countries

Denmark

References

Christensen M, Silbernagel KG, Zellers JA, Kjaer IL, Rathleff MS. Feasibility of an early progressive resistance exercise program for acute Achilles tendon rupture. Pilot Feasibility Stud. 2024 Apr 22;10(1):66. doi: 10.1186/s40814-024-01494-4.

Reference Type: DERIVED

PMID: 38650039 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

N-20180072

Identifier Type: -

Identifier Source: org_study_id