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IRCT20230328057780N1 IRCT 2023-06-26 Babol University of Medical Sciences Healthy lifestyle–based interventions on intrinsic capacity Effectiveness of healthy lifestyle–based interventions on intrinsic capacity in older women adults 2023-07-06 anticipated 240 Complete https://irct.ir/trial/69321 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A computer-generated balanced block randomization (Sealedenvelope.com) in a 1:1 ratio will be conducted. The sample size of the study will be 240 women, which will be arranged in 24 clusters of 10. For the allocation of the participants, an investigator with no clinical involvement in the trial generated the randomization sequence with 1:1 allocation ratio using random block sizes of 6. Allocation concealment will be performed by preparing 24 sealed and unnumbered envelopes containing a piece of paper printed with the word ‘Intervention’ or ‘Control’. N/A Elderly women. Intervention 1: Intervention group: the healthy-life program in the elderly people affiliated to Department of Elderly Health of the Ministry of Health will be used. This program has different parts, which include: a- nutrition, b- physical exercises, c- happy life, d- depression, e- balance. The interventions included eight sessions, with a time of 30 to 45 minutes. In each session, discussion and consultation will be done according to the selected topics and the objectives of the trial. The predetermined questions will be asked from participants. Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group. Intervention 2: Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is According to the results, a decision will be made at the end of the research.
public shabnam omidvar
Babol University of Medical Sciences, Ganj Afrooz Ave., Babol, Iran
Babol Iran (Islamic Republic of) 4717647745 011 32199592-1 shomidvar@yahoo.com Babol University of Medical Sciences scientific shabnam omidvar
Nursing and Midwifery faculty, Babol University of Medical Sciences
Babol Iran (Islamic Republic of) 4717647745 011 32199592-1 shomidvar@yahoo.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Women aged 60-80 years Healthy women who do not have any diagnosed neurological, physical or mental disorders 60 years 80 years Female Unwillingness to participate in the study Hormone therapy in the last two months History of substance abuse, addiction, smoking or alcohol History of eating disorders. Having severe physical activity Participate in another study at the same time Having a special diet, such as being vegetarian or eating raw foods. Lifestyle N/A Intervention group: the healthy-life program in the elderly people affiliated to Department of Elderly Health of the Ministry of Health will be used. This program has different parts, which include: a- nutrition, b- physical exercises, c- happy life, d- depression, e- balance. The interventions included eight sessions, with a time of 30 to 45 minutes. In each session, discussion and consultation will be done according to the selected topics and the objectives of the trial. The predetermined questions will be asked from participants. Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group. Intervention in the control group: No specific intervention is performed in the control group. And at the end of the course, after the completion of the intervention in the test group, the educational content will be provided to the control group. Inherent capacity. Timepoint: The inherent capacity will be assessed at the beginning and the end of trial. Method of measurement: The primary outcome of the present study is intrinsic capacity. The five main areas of intrinsic capacity include mobility, vitality, cognitive, psychological and sensory. 1. Mobility: SPPB (Short Physical Performance Battery) and TUG (Timed Up and Go Vitality: Mini-Nutrition assessment questionnaire. Cognitive: Mini-Cog questionnaire. Psychological: Geriatric Depression Scale (GDS) questionnaire. Sensory: hearing from Whisper self test, vision from WHO simple eye chart. Babol University of Medical Sciences Approved 2023-06-13 Ethics committee of Babol University of Medical Sciences Ganj Afrooz Ave., Babol, Iran. Babol Mazandaran Iran (Islamic Republic of)