High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia

Official title

Effect of High-Intensity Functional Training on Physical Performance and Mental Health in Elderly With Sarcopenia

Overview

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.

Detailed description

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).

1. Hand Dynamometer. 2. Short Physical Performance. 3. Quadriceps strength test 4. Montreal Cognitive Assessment 5. The Katz Index. 6. The Geriatric Depression Scale-15 (GDS-15). 7. 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.

Interventions

• Other High-Intenisity Functional Training
  A) Awarm up: for 5 min.warm-up (predominantly stretching) of the neck, shoulders, lower back, hips, knees and ankles. 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 squat
• Other Sham
  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.

Primary outcome measures

• Short Physical Performance Battery (SPPB) test [Time frame: 10 weeks]

Secondary outcome measures (6)

• Hand Dynamometer [Time frame: 10 weeks]
• Quadriceps strength test [Time frame: 10 weeks]
• Montreal Cognitive Assessment [Time frame: 10 weeks]
• The Katz Index [Time frame: 10 weeks]
• The Geriatric Depression Scale-15 (GDS-15) [Time frame: 10 weeks]
• The UCLA Loneliness Scale (Version 3) [Time frame: 10 weeks]

Eligibility criteria

Inclusion Criteria: 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.
• Timed Up-and-Go (TUG): ≥20 seconds.
• Age from 60 to 70 years old.
• Old individuals who will be found to have mild depression.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Egypt · 1 center

• Faculty of Physical Therapy — Giza

Identifiers

NCT: NCT07399301 · 202663

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗