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

NCT04121377 | Completed DMC

• 1 other identifier: N-20180072
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Achilles Tendon Rupture

Outcome Measures

Primary Outcomes (2)

• Acceptability

  The participants will rate their acceptability (willingness) to perform the exercises on a 7-point Likert scale ranging from "very unacceptable" to "very acceptable". This is not a measure of whether the patient's symptoms have improved to normal physical function or any other satisfactory level at the specific time, but if it matches, their expectations of the content of an exercise program in this early phase and how they tolerate performing the exercises. The intervention program is categorised as "Unacceptable" if rated as the three lower scores ("very unacceptable" to "slightly unacceptable") and categorised as "Acceptable" if rated as the four higher scores ("neither acceptable or unacceptable" to "very acceptable"). The exercise program is considered feasible if acceptability of the exercise program is 80%. Defined as: ≥13/16 patients will rate the acceptability of the intervention as "acceptable".

  At 10 week follow-up

• Compliance

  The participants will register the number of training sessions and exercises they perform each day in a training journal. The compliance is measured as the mean number of exercise sessions they perform. The timeframe will be from the day they start the exercises to the end of week 9. The exercise program is considered feasible if the adherence to the exercise program is 50%. Defined as: ≥13/16 patients will perform ≥ 50% of the exercise sessions possible from start to end of week 9.

  At 10 week follow-up

Secondary Outcomes (9)

• Fear of re-rupture

  At 2 and 10 weeks and at 3 months

• Achilles tendon total rupture score (ATRS)

  Baseline for a pre-rupture level and at 3 months

• Physical Activity

  Baseline for a pre-rupture level and at 3 months

• Achilles tendon resting angle (ATRA)

  At 10 weeks and at 3 months

• Achilles tendon length

  At 10 weeks and 3 months

Study Arms (1)

Resistance exercise program

EXPERIMENTAL

Early resistance exercise sessions and home program

Other: Resistance training

Interventions

Resistance training 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.

Resistance exercise program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aalborg University Hospital: lead

Study Sites (1)

Physiotherapy and Occupational Therapy, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 38650039 DERIVED

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marianne Christensen, MHSc

  Physiotherapy and Occupational Therapy, Aalborg University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PT, PHD student

Study Record Dates

• First Submitted: September 29, 2019
• First Posted: October 9, 2019
• Study Start: October 11, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: October 14, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share

Locations

DK (1)