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IRCT20230216057434N7 IRCT 2024-03-10 Self Funded Effects of lower limb strength training and aerobic exercise in combination with lifestyle modification in type II diabetes mellitus. Effectiveness of lower limb strength training and aerobic exercises in combination with lifestyle modification on strength, aerobic fitness and quality of life in patients with type II diabetes mellitus. 2024-03-15 anticipated 54 Complete https://irct.ir/trial/75867 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done through a computer software "Random allocation software Version 2. The total sample size will be entered with required number of participants to be allocated in two groups. An automated randomization list will be achieved with attrition rate included. The program starts running with the default settings. Users may run the program with the default settings or set the number of groups, the name of participants in each group and the sample size. Clicking the 'Generate' button produces the random sequence. Before generating the random sequence, the option window will be displayed and different randomization settings can be entered, Blinding description: Blinding will be done on part of outcome assessor who will be an experienced therapist. Patients will be assessed by him at the end of treatment session. He will be blinded about the type of intervention patient will receive. Patients will also be blinded about the type of intervention they will received. N/A Diabetes mellitus II. Intervention 1: Group A (Intervention group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that includes walking at a slow pace, followed by lower limb strength training and aerobic exercise. In the intervention group, patients will receive lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. Patients will perform these exercises in standing position with the assistance of a chair. For the 1st four weeks, the sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will progress to 1kg till 8th week. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which will consist of breathing exercises. The total session duration for the Intervention group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks. Lifestyle modification program which will include: Mediterranean diet instructions like consumption of fruit and vegetables (one or two portions a day), whole grains, legumes, and nuts it will also include a moderate quantity of fish and dairy products while minimizing the intake of meat, processed and industrial food. Healthy sleep instructions according to the guidelines developed by the American Academy of Sleep Medicine includes: setting a bedtime that is early enough for a person to get at least 7-8 hours of sleep, making your bedroom quiet and relaxing before sleeping, limiting exposure to bright light in the evening, turning off electronic devices at least 30 minutes before bedtime, don’t eat a large meal before bedtime, avoiding consuming caffeine in the afternoon or evening. Intervention 2: Group B (Control Group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that will include walking at a slow pace, followed by lower limb strength training and aerobic exercise. Lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. The patient will perform these exercises in a standing position with the assistance of a chair. For the 1st four weeks sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will be progressed to 1kg till 8th weeks. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The Patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which consist of breathing exercises. In unguided lifestyle instructions, the therapist will advise the patient to live a healthy life and eat a healthy diet without specific or detailed guidance or instructions. The total session duration for the Control group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is Real patient is involved
public Zainab Sheraz
House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
Faisalabad Pakistan 38000 +92 335 6600141 zainab.48@hotmail.com Riphah International University, Faisalabad scientific Zainab Sheraz
House no. 32, street no. 2, Rehman Town, adjacent Shahzad Colony, Satyana Road, Faisalabad
Faisalabad Pakistan 38000 +92 335 6600141 zainab.48@hotmail.com Riphah International University, Faisalabad Pakistan Pakistan Pakistan Pakistan Both male and female patients Age: 40 to 60 years Patient with diabetes type II diagnosed by physician 40 years 60 years Both Unsafe blood pressure Mental retardation Any recent surgery (cardiac, musculoskeletal and neurological) Fracture Limb amputation and joint replacement Central nervous system dysfunction (stroke, Parkinson disease) E11. 9 Diabetes mellitus II Treatment - Other Treatment - Other Group A (Intervention group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that includes walking at a slow pace, followed by lower limb strength training and aerobic exercise. In the intervention group, patients will receive lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. Patients will perform these exercises in standing position with the assistance of a chair. For the 1st four weeks, the sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will progress to 1kg till 8th week. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which will consist of breathing exercises. The total session duration for the Intervention group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks. Lifestyle modification program which will include: Mediterranean diet instructions like consumption of fruit and vegetables (one or two portions a day), whole grains, legumes, and nuts it will also include a moderate quantity of fish and dairy products while minimizing the intake of meat, processed and industrial food. Healthy sleep instructions according to the guidelines developed by the American Academy of Sleep Medicine includes: setting a bedtime that is early enough for a person to get at least 7-8 hours of sleep, making your bedroom quiet and relaxing before sleeping, limiting exposure to bright light in the evening, turning off electronic devices at least 30 minutes before bedtime, don’t eat a large meal before bedtime, avoiding consuming caffeine in the afternoon or evening Group B (Control Group) consisting of 27 patients will receive an exercise session of 3 minutes warm-up that will include walking at a slow pace, followed by lower limb strength training and aerobic exercise. Lower limb strength training in the form of resistance exercises which will consist of hip abduction/adduction with a sandbag worn on the ankle, step (hip and knee flexion/extension), and tiptoe (ankle flexion/extension) with sandbag worn on the ankle. The patient will perform these exercises in a standing position with the assistance of a chair. For the 1st four weeks sandbag weighing 0.5 kg will be worn with each exercise and performed for 8-15 times. After 4 weeks, the weight of the sandbag will be progressed to 1kg till 8th weeks. The total time for lower limb strength training exercises will be 20 minutes. Aerobic exercises will consist of 10 minutes of stationary cycling and 10 minutes of step-ups. The Patients will be instructed while doing step-ups, they will keep their back straight. The total time for aerobic exercises would be 20 minutes, followed by 2 minutes of cool-down exercises which consist of breathing exercises. In unguided lifestyle instructions, the therapist will advise the patient to live a healthy life and eat a healthy diet without specific or detailed guidance or instructions. The total session duration for the Control group will be 45 minutes and will repeat thrice a week, 24 sessions over 8 weeks. Strength. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment. Method of measurement: Five times sit to stand test. Aerobic fitness. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment. Method of measurement: Harvard step test. Quality of life. Timepoint: Assessment will be performed at 0 week (baseline) and at completion of 8 weeks treatment. Method of measurement: SF-36. N/A Approved 2024-03-01 Ethics committee of Riphah International University Faisalabad Riphah International University, Faisalabad Faisalabad Punjab Pakistan