Effect of High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Short Physical Performance Battery (SPPB) test
概览
简要总结
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Group(A):N= 30
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
i. 5 min warm-up ii. 40 min functional training exercises. iii. 5 min cool-down. Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.
详细描述
Sixty patients with age ranged from 60 to 70 years old with individuals who will be found to have sarcopenia will participate in the study, and will be recruited from nursing home in AL-Abadiyah.
Patients will be assigned into two equal groups randomly:
Group (B): N=30 Patients in this group will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants
Procedures:
(A)Evaluating procedures: Before starting the exercise program, a complete history and physical examination will be taken from each subject. Each subject of the two groups will undergo the following steps of measurements. The parameters will be recorded at the beginning and the end of the total study period (10 weeks).
- Hand Dynamometer.
- Short Physical Performance.
- Quadriceps strength test
- Montreal Cognitive Assessment
- The Katz Index.
- The Geriatric Depression Scale-15 (GDS-15).
- The UCLA Loneliness Scale (Version 3). (B) Intervention procedures: All patients will be classified into two equal groups; each group will consist of 30 patients.
I-Intervention for Group A :
Patients in this group will receive high-intensity functional training exercises 3 times per week for 10 weeks. The initial duration of each session was 30 min, and it could be increased progressively, along with the intensity of the exercises, up to 50 min. All sessions included the following:
i. 5 min warm-up ii. 40 min functional training exercises. Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study.
I. Sit to stand( Chair squats) II. Wall push up III. Overhead triceps extension IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min
II. Intervention for Group B :
The participants in the control group will receive sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 60 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •INCLUSION CRITERIA:
- •Old individuals who will be found to have sarcopenia as defined according to European Working Group on Sarcopenia in Older People (EWGSOP2) 2019 criteria, The EWGSOP2 defines sarcopenia as a muscle disease characterized by progressive and generalized loss of skeletal muscle mass and function. Diagnosis requires sequential assessment of three components
- •Low Muscle Strength: The primary criterion. Measured by:
- •Handgrip strength: Cut-offs are \<27 kg for men and \<16 kg for women using a dynamometer.
- •Chair Stand Test: ≥15 seconds for five rises indicates weakness.
- •Low Muscle Quantity or Quality: Assessed via:
- •o calf circumference (≤34 cm men, ≤33 cm women).
- •Poor Physical Performance: Indicates severe sarcopenia. Tests include:
- •Gait speed: ≤0.8 m/s over 4 meters.
- •Short Physical Performance Battery (SPPB): ≤8 points.
排除标准
- •Neurological disorders.
- •Vestibular or balance disorders.
- •Uncontrolled hypertension or heart diseases.
- •Recent surgeries or fractures.
- •Any psychological disorders.
- •Severe renal failure (glomerular filtration rate \< 30 mL/min).
- •moderate to severe liver failure.
- •The patients cannot follow instructions.
研究组 & 干预措施
high-intensity functional training exercises
A) Awarm up: for 5 min, B) Functional training exercises: The participants will be initially instructed to complete up to one set of 8 maximum repetitions for each type of exercise with first and second week, followed by two sets of 8 maximum repetitions in the third and fourth week, Then three sets of 12 maximum repetitions from the fifth week untile the end of the study I. Sit to stand( Chair squats)
II. Wall push up:
III. Overhead triceps extension:
IV. Leg kickbacks V. Wood chops exercise VI. Farmer's Carry training C) A cool down: for 5 min slow continuation of the activity.
干预措施: High-Intenisity Functional Training (Other)
sham therapy
Group (B): N=30 Patients in this group who will be found to have sarcopenia will receive sham exercises. Sham interventions are methodological tools used to treat participants in the study arm and the control arm in exactly the same way, except that the study group receives an active substance and the control group does not.Sham exercises that is commonly administrated as a light touch in the body or mimics the active treatment and aims at blinding of participants
干预措施: Sham (Other)
结局指标
主要结局
Short Physical Performance Battery (SPPB) test
时间窗: 10 weeks
The SPPB assesses physical performance through balance, strength, and gait measurements and is made up of a set of three tests: standing static balance ; lower limb strength and power through getting up and sitting on a chair; and walking speed at normal pace. Strength and gait are first evaluated by the ability to perform the tasks of getting up and sitting on a chair five times and performing the walking speed test (3 to 4 meters) and, second, by the time the individual takes to complete the tasks. The SPPB total score ranges from 0 (worst performance) to 12 points (best performance) and categorically evaluates performance in the tests using three classes of scores: three classes: 0-6 points (poor performance), 7-9 points (moderate performance), and 10-12 points (good performance).
次要结局
- Hand Dynamometer(10 weeks)
- Quadriceps strength test(10 weeks)
- Montreal Cognitive Assessment(10 weeks)
- The Katz Index(10 weeks)
- The Geriatric Depression Scale-15 (GDS-15)(10 weeks)
- The UCLA Loneliness Scale (Version 3)(10 weeks)
研究者
Neveen Mohammed Ibrahim Nawar
Physiotherapy Specialist at Damanhur Medical National Institute, EL-Behira, Egypt
Cairo University