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Trial registered on ANZCTR


Registration number
ACTRN12619000093189
Ethics application status
Approved
Date submitted
12/01/2019
Date registered
22/01/2019
Date last updated
22/01/2019
Date data sharing statement initially provided
22/01/2019
Date results information initially provided
22/01/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Multicomponent Physical Exercise in old adults after hospitalization: short vs long supervised programs
Scientific title
Effectiveness of Multicomponent Physical Exercise in old adults after hospitalization: short vs long supervised programs
Secondary ID [1] 296753 0
None
Universal Trial Number (UTN)
U1111-1224-8738
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 310648 0
Sarcopenia 311117 0
Condition category
Condition code
Physical Medicine / Rehabilitation 309361 309361 0 0
Physiotherapy
Musculoskeletal 309752 309752 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Physical Exercise program will be offered to people admitted in the service of Internal Medicine of the "Hospital Universitario de Alava" who meet certain criteria. Subjects who accepted to take part in the intervention will be randomly assigned (in a 1:1 ratio) after discharge to short- (6 weeks) or long- (12 weeks) supervised exercise programs. In both branches, participants will continue the program at home 18 weeks (short supervised) or 12 weeks (long supervised) until 24 weeks. The program consist of multicomponent physical exercise sessions designed to improve strength, power, balance and walking retraining conducted by experienced physical trainer. The program´s technical content is based on a previous experience of the authors with population at risk of frailty. The program will individualized based on each participant´s level and progression of physical fitness. Goals will be adapted in response to illness, injury or physical symptoms. The intervention will be adapted to meet the exercise and physical activity guidelines for older adults established by American College of Sport Medicine (ACSM) and American Heart Association. The intervention will consist of 60 minute group sessions (supervised) conducted twice a week where the exercises will be directed to improve strength and balance. An interval of at least 48 hours between training sessions will be respected. All sessions will begin with a brief warm-up of 5 minutes (range-of-motion exercises for the neck, wrists, shoulders, hip, knees and ankles). Strength training (35 minutes) will comprise upper and lower body exercises (arm curl, leg flexion, hip extension, leg abduction, standing on tips and heels, chair stand etc.) performed with external weights, which will be tailored to the individual´s functional capacity through Brzycki equation for the estimation of 1-RM (repetition maximum). In all strength tests subjects will be performed each exercise as forcefully as possible. In the first three weeks exercise will be performed with light loads (40-50% 1-RM) to ensure and appropriate adaption to resistance and thereafter loads will be increased to 60-70 % 1-RM to additional benefits if well tolerated.
Balance training (15 minutes) will include exercises in progressing difficulty starting by decreasing arm support (with 2 arms at first, with one hand, and finally none if possible) along with decreasing base of support (both feet together, semi-tandem and tandem position and increasing complexity of movements. Exercises will be varied through the period: weight transfer from one leg to another, walking with small obstacles, proprioceptive exercises and stepping practice. Sessions will finish with 5 minutes of cooling down by stretching, breathing and relaxing exercises. Walking retraining will be also implemented through individualized recommendations to perform out walking sessions on their own. Training attendance will be recorded every session. The unsupervised part was carried out following a weekly schedule given to the participants with the daily exercises they have to carry out. These exercises were learned in the supervised phase. Every two weeks by means of telephone calls a control of adherence was taken to support the participants and to clarify any doubt they have.
Intervention code [1] 313148 0
Treatment: Other
Comparator / control treatment
We will compare two interventions of physical exercise. One with short (6 week) supervised period (Control group) and the other with a longer (12 weeks) supervised period. Thereafter participants in both branches will continue the program at home on their own until 24 weeks.
Control group
Active

Outcomes
Primary outcome [1] 308429 0
The primary outcome measure will be the difference in function between intervention and control group assessed by changes in summary ordinal score on the Short Physical Performance Battery (SPPB). SPPB is a composite outcome to measure physical funcition of the lower limbs in older adults. It is also a good predictor of frailty and falls. SPPB consists of three tests: balance, gait ability and leg strength. The score for each test is given in categorical modality (0-4) based on run time intervals, and the total score will range from 0 (worst) to 12 points (best). The SPPB has been shown to be a valid instrument for screening frailty and predicting disability, institutionalization and mortality. A total score of less than 10 points indicates frailty and a high risk of disability and falls. 1 point change in the total score has demonstrated to be of clinical relevance.
Timepoint [1] 308429 0
Study assesment will be conducted by blinded research staff during cinic visits at baseline, the following week after the discharge as well as at 12 (primary endopoint) and 24 weeks from the beginning of the intervention.
Primary outcome [2] 318518 0
Time in each intensity of physical activity. This is a composite primary outcome. Active and sedentary periods during everyday life will be recorded with an accelerometer (Actigraph GT3X model (Actigraph LLC, Pensacola, FL, USA)) that participants will be worn on the hip with a belt for a 7 day period. The active-period intensities will be classified following the criteria developed by Freedson et al., 1998 as sedentary, light or moderate to vigorous activities and measured in minutes.
Timepoint [2] 318518 0
Study assesment will be conducted by blinded research staff during cinic visits at baseline, the following week after the discharge as well as at 12 (primary endpoint) and 24 weeks from the beginning of the intervention.
Primary outcome [3] 318519 0
Nutritional status will be measured by Mininutritional Assessment (MNA). he MNA has the following characteristics: * The MNA is a two step procedure: (1) the MNA-SF to screen for malnutrition and risk of malnutrition; (2) assessment of nutritional status with the full MNA. * The MNA is an 18-item questionnaire comprising anthropometric measurements (BMI, mid-arm and calf circumference, and weight loss) combined with a questionnaire regarding dietary intake (number of meals consumed, food and 2uid intake, and feeding autonomy), a global assessment (lifestyle, medication, mobility, presence of acute stress, and presence of dementia or depression), and a self-assessment (self-perception of health and nutrition).The MNA is well validated. It correlates highly with clinical assessment and objective indicators of nutritional status (albumin level, BMI, energy intake, and vitamin status). * A low MNA score can predict hospital-say outcomes in older patients and can be used to follow up changes in nutritional status.
Timepoint [3] 318519 0
Study assesment will be conducted by blinded research staff during cinic visits at baseline, the following week after the discharge as well as at 12 (primary endpoint) and 24 weeks from the beginning of the intervention.
Secondary outcome [1] 365227 0
Cognitive assessment measured by Montreal Cognitive Assessment Score. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total possible score is 30 points; a score of 26 or above is considered normal
Timepoint [1] 365227 0
Study assesment will be conducted by blinded research staff during cinic visits at baseline, the following week after the discharge as well as at 12 and 24 weeks from the beginning of the intervention.
Secondary outcome [2] 365228 0
A commercial enzyme-linked immunosorbent assay (ELISA) will use to measure myostatin serum concentration. Total myostatin (pg/mL) will be measured according to the manufacturer’s protocol (GDF8/Myostatin Quantikine ELISA Kit, R&D System Inc., Minneapolis, USA). To remove the pro-peptide from GDF-8 and to activate myostatin to immunoreactive protein detectable by the kit, a first step of sample activation was performed by acidification and neutralization reagents (pH 7.2-7.6).
Timepoint [2] 365228 0
Study assesment will be conducted by blinded research staff during cinic visits at baseline, the following week after the discharge as well as at 12 and 24 weeks from the beginning of the intervention.

Eligibility
Key inclusion criteria
Subjects will be considered eligible for the study if all of the following apply: Discharged from the Service of Internal Medicine of "Hospital Universitario de Alava" between aged greater than or equal to 70 years, scored greater than or equal to 50 on the Barthel Index, scored greater than or equal to 20 on MEC-35 Test (an adapted and validated version of MMSE in Spanish) who are all capable to stand up and walk independently for 10 m.
Minimum age
70 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be eligible for the study if they are clinically unstable under the clinical judgment of the medical professionals , or in any other condition that means that entering the
study would not be in the subject´s best interests.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Sample size has been calculated to detect minimal significant effects on the variable of physical performance (SPPB): accepting an alpha risk of 0.05 and a beta risk of 0.20 in a bilateral contrast, 63 individuals are required in order to detect a difference equal to or greater than 1 unit in the SPPB (SD= 2.00). It has been increased the sample size in an additional 20% (loss during follow-up) and 5% (mortality). The resultant sample size is determinate in 84 individuals, therefore 42 individuals per group (short and long supervised intervention groups).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21145 0
Spain
State/province [1] 21145 0
Araba

Funding & Sponsors
Funding source category [1] 301333 0
Government body
Name [1] 301333 0
Health Department of The Basque Government
Address [1] 301333 0
Donostia/San Sebastian 1
Vitoria-Gasteiz 01010
Country [1] 301333 0
Spain
Primary sponsor type
Hospital
Name
Hospital Universitario de Alava
Address
Calle Olagibel 29
01004 Vitoria Gasteiz
Country
Spain
Secondary sponsor category [1] 301211 0
University
Name [1] 301211 0
University of the Basque Country
Address [1] 301211 0
Barrio Sarriena s/
48950 Leioa (Bizkaia)
Country [1] 301211 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302073 0
CEIC DEL HOSPITAL UNIVERSITARIO DE ARABA
Ethics committee address [1] 302073 0
Departamento de Salud Gobierno Vasco
San Sebastian
o1010 Vitoria-Gasteiz
Ethics committee country [1] 302073 0
Spain
Date submitted for ethics approval [1] 302073 0
01/03/2017
Approval date [1] 302073 0
26/05/2017
Ethics approval number [1] 302073 0
Expte 2017-021

Summary
Brief summary
Community-dwelling older patients hospitalized for an acute illness usually decline their functional, nutritional and cognitive status. Physical exercise is the one of the effective interventions to revert the decline caused by hospitalization . As a consequence, the major aim of this study is to compare the effect of two physical exercise interventions in patients admitted in a Hospital Service of Internal Medicine after discharge. Both programs are multicomponent exercise interventions, including resistance exercises, balance and walking exercises. The difference between two interventions is the duration of supervised period in the hospital, one is short (6 week) and the other is longer (12 weeks). After finishing the supervised sesions, in both branches the programme will be continue at home until the week 24th. The effectiveness of the programs will be assessed by body composition and functional, nutritional, cognitive status. The results of this research will give information about imprementing physical exercise programmes in hospital in terms of efficacy and efficiency
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89030 0
Dr Ariadna Besga
Address 89030 0
Servicio de Medicina Interna
Hospital Universitario de Araba (Santiago)
Olaguibel, 29 1004 VITORIA-GASTEIZ
Vitoria-Gasteiz
Spain
Country 89030 0
Spain
Phone 89030 0
+ 34626682122
Fax 89030 0
Email 89030 0
ariadna.besgabasterra@osakidetza.org
Contact person for public queries
Name 89031 0
Prof Jon Irazusta
Address 89031 0
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n Leioa (Bizkaia)
48940 Spain
Country 89031 0
Spain
Phone 89031 0
+34946012837
Fax 89031 0
Email 89031 0
jon.irazusta@ehu.eus
Contact person for scientific queries
Name 89032 0
Prof Jon Irazusta
Address 89032 0
Department of Physiology
Faculty of Medicine and Nursing
Barrio Sarriena s/n Leioa (Bizkaia)
48940 Spain
Country 89032 0
Spain
Phone 89032 0
+34946012837
Fax 89032 0
Email 89032 0
jon.irazusta@ehu.eus

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Informed consent form
Ethical approval
How or where can supporting documents be obtained?
Type [1] 895 0
Ethical approval
Citation [1] 895 0
Link [1] 895 0
Email [1] 895 0
Other [1] 895 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 896 0
Conference abstract
Citation/DOI/link/details [1] 896 0
60 Congreso de la Sociedad Española de Geriatría y Gerontología

https://www.sciencedirect.com/science/article/pii/S0211139X18303147?via%3Dihub
Attachments [1] 896 0
Citation type [2] 923 0
Conference abstract
Citation/DOI/link/details [2] 923 0
23th Congress of the European College of Sports Science. Page 198.


http://wp1191596.server-he.de/DATA/CONGRESSES/DUBLIN_2018/Documents/DUBLIN_BOA_WEB.pdf
Attachments [2] 923 0
Citation type [3] 924 0
Conference poster
Citation/DOI/link/details [3] 924 0
Congress of the European Geriatrics Medicine. Page 121, P237; Page 308, P828

https://link.springer.com/epdf/10.1007/s41999-018-0097-4?shared_access_token=eGIVvZ8ADzr7xHtF5VILRfe4RwlQNchNByi7wbcMAY4ye865jdo9Xo4IY45fql5IxY8W1TnI5L3zYDTGPrjIEyp6LDWbL1fRv17Ue2KFoCWsIpSUDMgjHroh6tx3wepSVo4l88RJ1U6YZvSbc5SOQ8tfiPCEYrD5DTLjUNKGo4s%3D
Attachments [3] 924 0
Results – basic reporting
Results – plain English summary