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Strength training for the treatment of Cushing's associated myopathy: a randomised study

Organizational Data

DRKS-ID:
DRKS00024575
Recruitment Status:
Recruiting ongoing
Date of registration in DRKS:
2021-04-15
Last update in DRKS:
2023-10-04
Registration type:
Prospective

Acronym/abbreviation of the study

CAESAR

URL of the study

No Entry

Brief summary in lay language

Endogenous Cushing's Syndrome is a rare disease with severe comorbidities, such as Cushing's associated myopathy. This is often persistent in patients with Cushing's Syndrome despite successful therapy, which has an Impact on the Quality of life in the affected patients. The aim of this randomized, interventional study is to better understand Cushing's associated myopathy and the effects of physical Training on muscle function in this context.

Brief summary in scientific language

The overall aim of this study is the elucidation of the mechanism underlying hypercortisolism associated myopathy. To this end, the project addresses two distinct hypotheses: (i) that endogenous hypercortisolism impairs muscular function by multiple synergistic systemic and local mechanisms including protein catabolism, insulin resistance, sarcopenic obesity and fatty muscle degeneration, intramuscular inflammation and inactivity leading to adverse short- and long-term consequences for muscular health; (ii) that correction of hypercortisolism by curative surgery is able to restore muscular function if combined with a high intensity muscular training intervention. To this end, we will perform a randomized controlled intervention trial (RCT) in 14 patients with active Cushing’s syndrome shortly after curative surgery, 14 patients with Cushing's syndrome in long-term remission und 14 patients with metabolic syndrome. Patients with active Cushing's sydrome are randomized in an early intervention group (month 2-7 after surgery, n = 7) or in a late intervention group (month 8-13 after surgery: n = 7). The intervention consists of an individual training program aiming at increased physical activity, fitness and strength. Patients with Cushing's syndrome in long-term remission and metabolic syndrome treated similarly serve as controls. The study has three objectives: Objective 1 is covered by the baseline evaluation of the participants of the RCT, objective 2 by the intervention part of the RCT, and objective 3 by the molecular analysis performed on muscle biopsies obtained before and after intervention.

Health condition or problem studied

ICD10:
E24.9 - Cushing syndrome, unspecified
ICD10:
G73.5 - Myopathy in endocrine diseases
Healthy volunteers:
No

Interventions, Observational Groups

Arm 1:
Early intervention with individual physical training from 4 weeks after baseline/surgery to 13 months after baseline/surgery
Arm 2:
Standard follow-up in the first 7 months after baseline/surgery and late intervention with 6 months of individual physical training until 13 months after baseline/surgery

Endpoints

Primary outcome:
Grip strength after 6 month Intervention (at the time 7 months after baseline/Operation)
Secondary outcome:
Muscle function, diastolic dysfunction, body composition and muscle mass, quality of life

Study Design

Purpose:
Prognosis
Allocation:
Randomized controlled study
Control:
  • Control group receives no treatment
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting ongoing
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center LMU Klinikum München

Recruitment period and number of participants

Planned study start date:
2021-04-19
Actual study start date:
2022-04-01
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
42
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
60 Years
Additional Inclusion Criteria:
Cushing's syndrome: - path. Dexamethasone inhibition test - path. 23 o'clock salivary cortisol level - path. 24h-collection urine cortisol (>2.0 UNL) - planned surgery - Confirmed subtype: adrenal, pituitary or ectopic Cushing's syndrome in long-term remission: - Successfully treated Cushing's syndrome - Persisting functional impairment Metabolic syndrome: - Functional impairment - Exclusion of hypercortisolism - Central obesity and at least 2 of the following criteria: Serum triglycerides < 150 mg/dl; reduced serum HDL cholesterol < 50 mg/dl; art. Hypertension (> 130/85mmHg); elevated fasting blood glucose (> 100mg/dl) or type II diabetes - or drug treatment of any of these symptoms

Exclusion Criteria

- Age under 18 years or over 60 years - Contraindication to surgery - Existing pregnancy - Chronic general illness - Alcohol or drug abuse - Physical limitation to participate in the exercise program - Participation in another interventional clinical trial - Life expectancy of less than one year - Myocardial infarction within the past 3 months - Cardiopulmonary instability or ischemia signs during exercise testing - Cytostatic therapy

Addresses

Primary Sponsor

Medizinische Klinik und Poliklinik IV, LMU Klinikum München
Ziemssenstraße 5
80336 München
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Medizinische Klinik und Poliklinik IV LMU Klinikum München
Prof. Dr. Martin Reincke
Ziemssenstraße 5
80336 München
Germany
Telephone:
+49 (0)89 4400-57544
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Medizinische Klinik und Poliklinik IV LMU Klinikum München
Prof. Dr. Martin Reincke
Ziemssenstraße 5
80336 München
Germany
Telephone:
+49 (0)89 4400-57544
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Medizinische Klinik und Poliklinik IV LMU Klinikum München
Prof. Dr. Martin Reincke
Ziemssenstraße 5
80336 München
Germany
Telephone:
+49 (0)89 4400-57544
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

Deutsche Forschungsgemeinschaft
Kennedyallee 40
53175 Bonn
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.dfg.de

Ethics Committee

Address Ethics Committee

Ethikkommission der Med. Fakultät der LMU
Pettenkoferstraße 8
80336 München
Germany
Telephone:
+49-89-440055191
Fax:
+49-89-440055192
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-03-18
Ethics committee number:
18-0430
Vote of the Ethics Committee:
Approved
Date of the vote:
2021-04-12

Other Address Ethics Committee

Ethikkommission der Technischen Universität München
Ismaninger Str. 22
81675 München
Germany
Telephone:
+49-89-41407737
Fax:
No Entry
Contact per E-Mail
URL:
http://www.ek-med-muenchen.de/index.php?lang=de

Vote of the Ethics Committee

Vote of the Ethics Committee:
No approval required according to the EC
Date of the vote:
2021-09-01

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry