Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001408178p
Ethics application status
Not yet submitted
Date submitted
26/03/2019
Date registered
14/10/2019
Date last updated
14/10/2019
Date data sharing statement initially provided
14/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A novel development of liver-targeted androgen therapy for sarcopenia and synergistic benefit of resistance training in elderly
Scientific title
A novel development of liver-targeted androgen therapy for sarcopenia and synergistic benefit of resistance training in elderly
Secondary ID [1] 297810 0
None
Universal Trial Number (UTN)
U1111-1230-6878
Trial acronym
ANDANTE
Linked study record
NA

Health condition
Health condition(s) or problem(s) studied:
Sarcopenia 312174 0
Condition category
Condition code
Musculoskeletal 310724 310724 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Oral crystalline unconjugated testosterone 40 mg/day for 6 months. Testosterone will be administered in 1 capsule (13.3 mg/capsule) 3 times a day. Adherence will be monotored by returned unused capsules.
Participants will be randomized to either receive progressive resistance training or no training for 6 months.
Participants in the resistance training group will perform a partially supervised resistance training program for 6 months. Individually supervised sessions (~40 min) will be performed twice per week at the exercise laboratory at UNSW. For each session, participants will perform a warm-up of 5 minutes’ of low-intensity walking on the treadmill and lower-body flexibility exercises. This will be followed by ~ 30 minutes of upper- and lower-body resistance training, such as leg press, leg extension, calf raise, chest press, and seated row. In addition, resistance bands and adjustable dumbbells will be used to strengthen the muscle groups not targeted specifically by the resistance machines. The final 5 min of each session will be a cool down period, involving stretching of the major muscle groups.
In addition to supervised sessions, participants will be asked to perform one home-based resistance training session per week, with 8-10 exercises targeting the major muscle groups using adjustable dumbbells and body weight loading.
Online instructional videos and a printed training manual will also be provided for each exercise. Compliance to training will be recorded in a training log by the participants.

Thus, there will be four groups (active drug+training, active drug no training, placebo drug + training, placebo drug no training).
Intervention code [1] 314051 0
Treatment: Drugs
Intervention code [2] 314052 0
Treatment: Other
Comparator / control treatment
Placebo microcellulose capsules for 6 months.
Participants will be randomized to either receive progressive resistance training or no training for 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 319568 0
Muscle mass. Will be assessed using DXA.
Timepoint [1] 319568 0
Baseline, 3 months and 6 months of intervention.
(there is no primary timepoint)
Secondary outcome [1] 368697 0
Activity, measured by Fitbit.
Timepoint [1] 368697 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [2] 368698 0
Handgrip strength, will be measured by dynamometer (Jamar Plus digital dynamometer)
Timepoint [2] 368698 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [3] 368699 0
Upper limb muscle strength will be measured by isometric dynamometer.
Timepoint [3] 368699 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [4] 368700 0
Sit-to-stand test, a functional test that measures lower extremity strength and is done over 30 seconds
Timepoint [4] 368700 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [5] 368701 0
Timed get-up-and-go test, a functional test involving 3 m walk.
Timepoint [5] 368701 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [6] 368702 0
Stair-climb test
Timepoint [6] 368702 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [7] 368703 0
Balance test, assessed by PPA Sway Path software.
Timepoint [7] 368703 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [8] 368704 0
Reactive balance assessment, by slip and trip test.
Timepoint [8] 368704 0
Baseline and at 6 months of intervention.
Secondary outcome [9] 368705 0
Quality of Life, assessed by the Sarcopenia Quality of Life (SarQoL) questionnaire
Timepoint [9] 368705 0
Baseline, 3 months and 6 months of intervention.
Secondary outcome [10] 375524 0
Lower limb muscle strength will be measured by isometric dynamometer.
Timepoint [10] 375524 0
Baseline, 3 months and 6 months of intervention.

Eligibility
Key inclusion criteria
Community dwellers with sarcopenia but independent mobility. Sarcopenia will be defined by established clinical criteria: handgrip strength of 37 kg or less for men and 21 kg or less for women; or 12 seconds or more to rise 5 times from a chair with arms folded on the chest. Participants should be able to walk at least 10 m and climb at least one stair step without assistance.
Minimum age
75 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Overt cardiac failure, active non-skin malignancy, diabetes mellitus, uncontrolled hypertension (systolic BP > 160 mmHg), end-stage kidney or liver failure, recent fractures, neurological impairments, joint replacements, planned surgery within next 6 months, and BMI>35 kg/m2.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomization by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer software generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
Participants are only blinded to one part of their assigned treatment (testosterone vs placebo)
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Factorial design will be used to analyse the effects of liver-targeted testosterone or resistance training on body composition parameters, physical activity, QOL, and muscle function. Appropriate multiple comparison procedures will be used to compare individual treatment effects to baseline, and intervention to placebo at each time point. The relationship between physical activity scores and the various endpoint measures will be studied by including physical activity as a covariate in the models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2020
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
212
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13485 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 26104 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 302335 0
University
Name [1] 302335 0
University of New South Wales
Country [1] 302335 0
Australia
Primary sponsor type
University
Name
UNSW Sydney
Address
UNSW Sydney NSW 2052
Country
Australia
Secondary sponsor category [1] 302214 0
None
Name [1] 302214 0
Address [1] 302214 0
Country [1] 302214 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 303008 0
South Eastern Sydney Local Health District HREC
Ethics committee address [1] 303008 0
G71 East Wing Edmund Blacket Building Prince of Wales Hospital Barker St, Randwick NSW 2031
Ethics committee country [1] 303008 0
Australia
Date submitted for ethics approval [1] 303008 0
20/11/2019
Approval date [1] 303008 0
Ethics approval number [1] 303008 0

Summary
Brief summary
A randomized controlled trial will establish the extent of an increase in muscle mass and function during the novel liver-targeted testosterone therapy in older men and women with sarcopenia. We will combine this with progressive resistance training component in half of the patients to investigate independent and exercise-stimulated synergistic effects of resistance training and liver-targeted testosterone in improving muscle mass and function in sarcopenia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 92150 0
Dr Vita Birzniece
Address 92150 0
UNSW Sydney NSW 2052
Country 92150 0
Australia
Phone 92150 0
+61 02 92958483
Fax 92150 0
Email 92150 0
[email protected]
Contact person for public queries
Name 92151 0
Dr Vita Birzniece
Address 92151 0
UNSW Sydney NSW 2052
Country 92151 0
Australia
Phone 92151 0
+61 02 92958483
Fax 92151 0
Email 92151 0
[email protected]
Contact person for scientific queries
Name 92152 0
Dr Vita Birzniece
Address 92152 0
UNSW Sydney NSW 2052
Country 92152 0
Australia
Phone 92152 0
+61 02 92958483
Fax 92152 0
Email 92152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is an investigator-initiated study


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.