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IRCT20190504043468N1 IRCT 2020-08-05 Kharazmi University Effects of low-intensity training on patients with Alzheimer's disease The effect of twelve weeks of low intensity combined exercise with visual stimulation on cognitive and physical performance and brain wave changes of Alzheimer's patients 2019-12-21 anticipated 32 Complete https://irct.ir/trial/39297 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Allocating subjects to the study groups (intervention and control) was done through block randomization using blocks of size 4. This was done by the website (https://www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, two subjects were from the intervention group and two subjects were from the control group, which was arranged randomly. Finally, eight blocks were used, Blinding description: Practitioners, assessor, and analysts are not in the research team. 2 Alzheimer's disease. Intervention 1: Intervention group: Low-intensity compound exercises. The participants in the intervention group will perform 24 workouts twice a week for 12 weeks. Each session lasts about 40-60 minutes, including ten minutes of warm-up, 20-40 minutes of main exercises, and ten minutes of cool down. The participants adhered to a combined protocol, including brain activities (eyes-closed training and cognitive activities) and physical activities (muscle endurance, balance, and aerobic capacity). The main training protocol consisted of five parts. The first part of the training protocol includes sitting and standing on an armchair, accompanies by shoulder girdle strengthening (three sets with 5-15 reps, followed by a gradual increase in resistance and repetition, using dumbbells and Pilates bands). The second part includes crossing over five sponge obstacles (height: 15-20 cm) with eyes closed (two repetitions in the first three sessions, gradually increasing to two reps every three sessions); the distance between the obstacles is variable. In the third part, the participants cross over a safe balance beam board (2 m) with eyes closed (two repetitions in the first three sessions, gradually increasing to two reps every three sessions). In the fourth part, six-vowel stations are placed in a semicircular arrangement at a four-meter distance in front of the subject with eyes closed. The subjects would asked to identify the sound of each station, move toward it, perform the predetermined exercises for 15 seconds (e.g., butterfly curls, Hercules curls, knee raises, hand raises, and biceps curls), and return. There are only two stations in the first session, which increases by one station every three sessions to reach a total of six stations. In the last part, there are four colored lights in front of the participants, each indicating a predetermined exercise. As long as the light is on (10-15 seconds), the subject is required to perform the relevant exercise (e.g., red light: side-right lunge; blue light: side-left lunge; green light: backward right lunge; and yellow light: backward left lunge). This part will last for two minutes in the first session, which increases by one minute every three sessions to reach five minutes by the end. The exercises will change every three sessions and became more intense. The workouts are performed individually, and each individual will attend the center at a certain time. To monitor the workout intensity, heart rate (HR) is monitored by a smart watch. In this study, no specific drug is used. Intervention 2: Control group: without any intervention and training. No - There is not a plan to make this available Justification or reason for not sharing IPD is Because of ethic issues
public Sadegh Amani-Shalamzari
Kharazmi University, Daneshgah square, Shahid Beheshti street, Karaj
Karaj Iran (Islamic Republic of) 37551-31979 +98 26145796000 amani_sadegh@yahoo.com Kharazmi University scientific Sadegh Amani-shalamzari
Kharazmi University, Daneshgah square, Shahid Beheshti street, Karaj
Karaj Iran (Islamic Republic of) 37551-31979 +98 45796000261 amani_sadegh@khu.ac.ir Kharazmi University Iran (Islamic Republic of) age range (50 -70 yr) ability to do exercise stage 1 and 2 Alzheimer's disease 50 years 75 years Both Patients who are unable to walk or stand Patients suffering from Alzheimer's disease due to severe depression Alzheimer's patients who have this disease because of a heart attack Alzheimer's patients who develop Alzheimer's due to obstruction of the cerebrovascular system Patients with cardiovascular problems who are not allowed to exercise by their doctor G30.0 Alzheimer disease with early onset Rehabilitation Rehabilitation Intervention group: Low-intensity compound exercises. The participants in the intervention group will perform 24 workouts twice a week for 12 weeks. Each session lasts about 40-60 minutes, including ten minutes of warm-up, 20-40 minutes of main exercises, and ten minutes of cool down. The participants adhered to a combined protocol, including brain activities (eyes-closed training and cognitive activities) and physical activities (muscle endurance, balance, and aerobic capacity). The main training protocol consisted of five parts. The first part of the training protocol includes sitting and standing on an armchair, accompanies by shoulder girdle strengthening (three sets with 5-15 reps, followed by a gradual increase in resistance and repetition, using dumbbells and Pilates bands). The second part includes crossing over five sponge obstacles (height: 15-20 cm) with eyes closed (two repetitions in the first three sessions, gradually increasing to two reps every three sessions); the distance between the obstacles is variable. In the third part, the participants cross over a safe balance beam board (2 m) with eyes closed (two repetitions in the first three sessions, gradually increasing to two reps every three sessions). In the fourth part, six-vowel stations are placed in a semicircular arrangement at a four-meter distance in front of the subject with eyes closed. The subjects would asked to identify the sound of each station, move toward it, perform the predetermined exercises for 15 seconds (e.g., butterfly curls, Hercules curls, knee raises, hand raises, and biceps curls), and return. There are only two stations in the first session, which increases by one station every three sessions to reach a total of six stations. In the last part, there are four colored lights in front of the participants, each indicating a predetermined exercise. As long as the light is on (10-15 seconds), the subject is required to perform the relevant exercise (e.g., red light: side-right lunge; blue light: side-left lunge; green light: backward right lunge; and yellow light: backward left lunge). This part will last for two minutes in the first session, which increases by one minute every three sessions to reach five minutes by the end. The exercises will change every three sessions and became more intense. The workouts are performed individually, and each individual will attend the center at a certain time. To monitor the workout intensity, heart rate (HR) is monitored by a smart watch. In this study, no specific drug is used. Control group: without any intervention and training Cognitive changes. Timepoint: Once before practicing and once again at the end of twelve weeks of practice. Method of measurement: The questionnaire was based on the diagnosis of a physician and SPMSQ, cognitive status questionnaire MMSE; mental status brief examination ; Knowledgeable cognitive decline questionnaire on IQCDE ; The European dimension of the five dimensional quality of life D-EuroQol; Depression Scale of the Elderly GDS;. Memory. Timepoint: Once before practicing and once again at the end of twelve weeks of practice. Method of measurement: ROLAND RUDAS global demographics scale. Physical performance. Timepoint: Once before practicing and once again at the end of twelve weeks of practice. Method of measurement: The chair sit and reach test; Maximal isometric handgrip strength test; The timed up and go; The six minute walk test;. Brain waves changes. Timepoint: Once before practicing and once again at the end of twelve weeks. Method of measurement: electroencephalogram. Kharazmi University Approved 2019-03-11 Ethics Committee for Research in Sport Science Research Institute No 3; Fifth Alley; Miramad avenue; Motahari avenue Tehran Tehran Iran (Islamic Republic of)