Cycloergometer and Rotator Cuff Tear

NCT02929433 | Completed

• 1 other identifier: cts 2012-13
• Study Type: interventional
• Target: 38
• Locations: 0 countries
• Sites: N/A

Brief Summary

The cycloergometer is a mechanical device consisting of a bicycle frame fixed on a support base, designed to measure the amount of muscle work performed during exercise and the resistance to pedaling. The cycloergometer has been already employed in many fields of medicine. However, up to date, a little use of cycloergometer in the management of chronic joint diseases has been documented and scientific studies have not clarified if cycloergometer is effective in these diseases and, particularly, in Rotator Cuff Tear patients.

Conditions

Rotator Cuff Tear

Keywords

disability; pain; Rotator Cuff Tear; rehabilitation; range of motion (ROM)

Outcome Measures

Primary Outcomes (1)

• Visual Numeric Scale (VNS)

  The scale evaluated shoulder pain during activity

  Change from Baseline VNS at 6 months after the out-patient rehabilitation

Secondary Outcomes (2)

• Constant-Murley scale

  Change from Baseline Constant-Murley scale at 6 months after the out-patient rehabilitation

• Health Assessment Questionnaire (HAQ)

  Change from Baseline HAQ at 6 months after the out-patient rehabilitation

Study Arms (2)

Cycloergometer group

EXPERIMENTAL

Training at home with the cycloergometer per 20 minutes twice a day. The protocol suggested a continous use of the cycloergometer for a period of 6 months after 2 weeks of rehabilitation as outpatient.

Other: Cycloergometer

Control group

NO INTERVENTION

Usual care after a period (2 weeks) of rehabilitation as outpatient.

Interventions

Cycloergometer OTHER

Daily training of the RCT patients was provided by the use of a cycloergometer at home. Educational support once a month was guaranteed by a nurse of the telemedicine service

Cycloergometer group

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• positive imaging diagnosis of full-thickness RCT
• surgery not considered as the first treatment of choice
• willingness to sign the informed consent form.

You may not qualify if:

• inflammatory rheumatic diseases
• history of fracture or operations around the shoulder region
• neurological diseases
• infections or tumours
• diabetes
• coagulation diseases
• intra-articular injections of the involved shoulder within the last 12 months.

Sponsors & Collaborators

• Fondazione Salvatore Maugeri: lead

MeSH Terms

Conditions

Rotator Cuff Injuries; Pain

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bernardo Gialanella, MD

  Fondazione Salvatore Maugeri

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 11, 2016
• Study Start: January 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: October 11, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will share