Plain English Summary
Background and study aims
Sarcopenia is the age-related loss of skeletal muscle mass, strength and function. This can lead to problems with walking and balance, increased risk of falling, loss of independence, decreased quality of life and disability. The main treatments are medicines, a nutritional approach and physical activity/exercise. Despite this knowledge, there are no guidelines as to what type of therapeutic exercise is the best. Given the above, the aim of this study is to investigate the effects of two different exercise programs; a group-based exercise programme and a home-based exercise programme, both targeted to improve various parameters of quality of life.
Who can participate?
Adults aged 60 and above who have sarcopenia (pre-sarcopenia, sarcopenia, severe sarcopenia)
What does the study involve?
The sarcopenic participants are randomly allocated to one of three groups; group-based exercise, individual home based exercise and control group. Those in the first group undergo a supervised group exercise programme. These participants will also walk for at least 100 minutes per week for 12 weeks. Those in the second group undergo a home-based exercise programme. These participants will also walk for at least 100 minutes per week for 12 weeks. Those in the third group receive a leaflet with educational advice about sarcopenia. The same number of exercises are performed by both groups. Participants are assessed before the exercise programme, immediately after (at 12 weeks) and at 12 weeks after the exercise programme has finished (24 weeks). They will also complete questionnaires at 1 year.
What are the possible benefits and risks of participating?
Participants may benefit from improvements in their symptoms. There are no notable risks of participating. Participation in the study is voluntary. Participants can refuse to participate or stop participating at any time. All information obtained for this study is used for research purposes only and will be kept strictly confidential.
Where is the study run from?
This study is run in 3 different sites in the small county of Achaia in mainland Greece.
1.University Hospital of Patras
2.Technological Educational Institute (TEI)of Western Greece
3.2nd Open Care Centre of Patras
When is the study starting and how long is it expected to run for?
February 2017 to February 2018
Who is the main contact?
1. Mrs Maria Tsekoura (Scientific)
2. Professor John Gliatis (Scientific)
Trial website
Contact information
Type
Public
Primary contact
Mrs Maria Tsekoura
ORCID ID
Contact details
Psaron 6
Aigio
25100
Greece
+302691061150
mariatsekoura@hotmail.com
Type
Public
Additional contact
Prof John Gliatis
ORCID ID
Contact details
University Hospital of Patra
PATRA
26504
Greece
2613603000
gliatis@hotmail.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2011
Study information
Scientific title
The relationship between therapeutic exercise and parameters of quality of life in patients with sarcopenia
Acronym
ESARQOL
Study hypothesis
Patients with sarcopenia could benefit from a group-based and a home-based exercise programme
Ethics approval
Technological Educational Institute of Western Greece ethics committee, 13/03/2017, 4052/13-03-2017
Study design
Single-blind randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Community
Trial type
Not Specified
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Sarcopenia
Intervention
Participants are randomized into three groups – Group A, Group B and Group C
Group A: Participants receive supervised group therapeutic exercises two times per week for 12 weeks. Furthermore they walk for 100 min per week (minimum).
Group B: Participants receive home therapeutic exercises for 12 weeks. Furthermore they walk for 100 min per week (minimum).
Group C: Participant receive a leaflet with educational advice on diet, lifestyle and activity.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
1. Quality of life is assessed using the Sarcopenia Quality of Life (SarQol) questionnaire at baseline, 12 weeks, 24 weeks and 12 months
2. Muscle strength is assessed with Biodex isokinetic dynamometer for knee flexors and extensors at baseline, 12 weeks and 24 weeks
3. Gait speed is assessed using the 4-m test at baseline, 12 weeks and 24 weeks
Secondary outcome measures
1. Function is assessed using the Timed Up and Go Test and sit to stand test (5 repetitions) at baseline, 12 weeks and 24 weeks
2. Fatigue is assessed using the FSS questionnaire at baseline, 12 weeks, 24 weeks and 12 months
3. Fear of falling is assessed using the FES questionnaire at baseline, 12 weeks, 24 weeks and 12 months
4. Body composition and Muscle mass is assessed using Bioelectrical impedance analysis (Tanita BC 601) at baseline, 12 weeks and 24 weeks
5. Calf measurement is assessed in cm at baseline, 12 weeks and 24 weeks
6. Depression and anxiety is assessed using the HADS questionnaire at baseline, 12 weeks and 24 weeks
7. Hand grip muscle strength is assessed with handheld grip dynamometer (SAEHAN) at baseline, 12 weeks and 24 weeks
8. Balance is assessed with the Berg Balance Scale at baseline, 12 weeks and 24 weeks
9. Nutrition is assessed with the SNAG questionnaire at baseline, 12 weeks, 24 weeks and 12 months post exercise
10. Physical activity is assessed with PASE questionnaire at baseline
11. Mental state is assessed with the Mini Mental Scale at baseline
Overall trial start date
17/02/2016
Overall trial end date
20/03/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Sarcopenic patients according the European Working Group on Sarcopenia in Older People criteria (EWGSOP)
2. Aged 60 years and older
3. Not currently engaged in exercise training (within last 3 months)
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Cognitive impairments
2. Neurological disorders
3. Pacemaker fitted
4. Cardiovascular diseases or high blood pressure not controlled with medication
5. Surgery on lower limbs affecting gait
6. Medical or other musculoskeletal problems that could affect ability to complete objective assessments, or exercise with safety
7. Currently engaged in exercise training (within last 3 months)
Recruitment start date
14/03/2017
Recruitment end date
20/02/2018
Locations
Countries of recruitment
Greece
Trial participating centre
University Hospital of Patras
Rio
Patra
26500
Greece
Trial participating centre
Technological Educational Institute (TEI) of Western Greece, Physiotherapy department
Psaron 6
Aigio
25100
Greece
Trial participating centre
2nd Open Care Center for the elderly
Kazantzaki Nikou 21
Patra
26442
Greece
Sponsor information
Organisation
Technological Educational Institute (TEI) of Western Greece
Sponsor details
Psaron 6
Aigio
25100
Greece
0030 26910 61150
ftherapia@teiwest.gr
Sponsor type
University/education
Website
Funders
Funder type
Not defined
Funder name
investigator initiated and funded
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
IPD sharing statement
The datasets generated during and/or analysed during the current study will be stored in a non-publicly available repository (Laboratory of Human Assessment and Rehabilitation repository) accessible by study contact Maria Tsekoura and her supervisor, Professor John Gliatis. Data will be available from Maria Tsekoura on reasonable request. All participants agreed to participate and signed an informed consent form. Names of participants on the datasets are with codes, ensuring anonymisation. Statistical Analyses described are performed using IMB SPPS Statistics 20.0.
Intention to publish date
20/09/2018
Participant level data
Stored in repository
Basic results (scientific)
Publication list