Protocol summary
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Study aim
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Evaluation of the effect of resistance training protocol and comparison of detraining and two types of maintenance training protocols on serum levels of IGF-1, MSTN and some functional factors in sarcopenic elderly women
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Design
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Forty sarcopenic elderly women are randomly divided into two groups: resistance training (n = 30) and control (n = 10). After performing the intervention at the end of week 8, the training group is randomly divided into three groups: maintenance training 1 (10 people), maintenance training 2 (10 people) and detraining group (10 people). Then, the maintenance training protocol is performed at a dose lower than the initial dose and its effect on maintaining the adaptations resulting from resistance training at the end of week 12 is investigated.
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Settings and conduct
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Resistance training will be done in the gym of Shiraz University Sports Center located on Saheli Street.
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Participants/Inclusion and exclusion criteria
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Older women over 60 years who have a muscle mass index of less than 6.76 kg / m2, grip strength of less than 20 kg and a speed of less than 8 m / s, and do not have severe musculoskeletal abnormalities or hypertension.
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Intervention groups
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Stage 1: Resistance Training and Control Group
Stage 2: Maintenance Training Group 1, Maintenance Training Group 2, detraining Group and Control Group
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Main outcome variables
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Insulin-like growth factor-1, myostatin, muscle cross-section, muscle thickness, hand grip strength, gait speed, maximum dynamic strength, maximum oxygen consumption
General information
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Reason for update
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Adding the actual recruitment date and changing the registration to "Prospective"
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200828048549N1
Registration date:
2021-04-04, 1400/01/15
Registration timing:
prospective
Last update:
2022-07-13, 1401/04/22
Update count:
1
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Registration date
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2021-04-04, 1400/01/15
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-01-20, 1399/11/01
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Expected recruitment end date
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2021-03-20, 1399/12/30
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Actual recruitment start date
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2021-04-09, 1400/01/20
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Actual recruitment end date
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2021-04-19, 1400/01/30
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Trial completion date
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2021-08-22, 1400/05/31
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Scientific title
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The effect of resistance training, detraining and maintenance training on Catabolic, Anabolic and Functional factors in elderly women
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Public title
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The effect of resistance training on elderly women muscles
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Purpose
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Health service research
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Inclusion/Exclusion criteria
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Inclusion criteria:
Muscle mass less than 6.76 kg/m2 measured by Bioelectrical Impedance Analysis
Muscle strength less than 20 kg
Walking speed less than 0.8 m/s
Age more than 60 years
no experience in resistance training
Exclusion criteria:
Musculoskeletal abnormalities
Stroke
sever Hypertention
alzheimer and Parkinson disease
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Age
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From 60 years old to 75 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
50
Actual sample size reached:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random allocation will be done with the balanced block method and 4 blocks will be used. Subjects will be placed in these blocks in order of entering the study and each patient randomly will be assigned to the study groups.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-06-08, 1399/03/19
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Ethics committee reference number
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IR.SUMS.REHAB.REC.1399.013
Health conditions studied
1
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Description of health condition studied
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Sarcopenia
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Insulin like growth factor-1
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Blood serum sample
2
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Description
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Myostatin
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Blood serum sample
3
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Description
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hand grip strength
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Hand Dynamometer
4
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Description
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Muscle Mass
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Bioelectric impedance analyzer
5
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Description
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Walking speed
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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6 meters Walking test
6
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Description
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Muscle Cross Sectional Area
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Sonography
7
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Description
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Muscle Tickness
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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Sonography
8
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Description
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Maximum strength
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Timepoint
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week 0,week 8 and week 12
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Method of measurement
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1 Repetition Maximum
Intervention groups
1
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Description
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Intervention group: Resistance Training: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 3 sessions per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
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Category
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Treatment - Other
2
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Description
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Intervention group: Maintenance Training 1: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 2 sessions per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
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Category
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Treatment - Other
3
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Description
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Intervention group: Maintenance Training 2: The 8-week training protocol includes 2 mesocycles. The first mesocycle, 2 weeks (6 sessions / 1 session per week / 2 to 4 sets, repetitions 8 to 15 and each session includes 8 training movements) and the second mesocycle, 6 weeks strength protocol (18 sessions / 3 sessions per week / 2 to 3 sets, 4 to 6 repetitions, 20 minutes of recovery, 2 repetitions in fatigue, 20 minutes of recovery and 1 or 2 repetitions until reaching helplessness and each session includes 8 training movements). At the beginning and end of the session, warm up for 5 minutes and cool down for 5 minutes with low intensity using movements such as walking, jogging and light stretching exercises. A training session lasts approximately 35 minutes. In this study, in order to comply with the principle of overload, the workload will increase by 5-10% on a weekly basis in proportion to the ability of the subjects.
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Category
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Treatment - Other
4
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Description
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Intervention group: detraining: They will leave the training for 4 weeks and will have no activities other than normal daily activities.
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Category
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Treatment - Other
5
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Description
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Control group: Control
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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Zeinab Hooshmandi
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable
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Title and more details about the data/document
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Information about the average of all data will be published.
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When the data will become available and for how long
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Access starts 12 months after the publication of results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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Mentioning the name of the researcher of this study, the use of data is allowed.
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From where data/document is obtainable
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Zeinab Hooshmandi, phone number: 00989171248067, E-mail: z_hoshmandi@yahoo.com
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What processes are involved for a request to access data/document
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Access to the data will be possible one month after submitting the application and subject to the terms of use of the data.
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Comments
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Researchers who apply to use the data are only allowed to use the general average of the data, and mentioning the names of the main researchers in preparing the data of this research (Zeinab Hooshmandi and Farhad Darianush) is one of the conditions for using the data.