Integrated Physical Training With Protein Diet in Older Adults With Sarcopenia Symptoms.

NCT05224453 | Completed Results DMC

• 1 other identifier: RHPT/020/051
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Sarcopenia is the major health concern and common consequence of COVID-19 in the aging population. Moreover, this clinical condition has not been considered in usual physical rehabilitation practice, and its optimal protein requirement in food is not well defined, which requires a meaningful study in this field. The reports of this trial would deliver the latest evidence and proper guidelines for the prescription of physical exercises and also provide an optimal dietary plan in sarcopenia patients with COVID infection. Objective: To find and compare the clinical and psychological effects of integrated physical training with a high protein diet versus a low-protein diet in community-dwelling COVID-19 asymptomatic older adults with Sarcopenia symptoms.

Conditions

Sarcopenia

Keywords

COVID-19; Sarcopenia; physical training; muscle strength; muscle mass; Quality of life; protein diet

Outcome Measures

Primary Outcomes (1)

• Changes in Hand Grip Strength

  The test is easy to perform and a less expensive one. It measures the strength of upper extremity by using a device handheld dynamometer. The participant was instructed to press the hand piece of the dynamometer to the maximum of his ability and the values shown on the display were recorded. Three values were noted for each participant and the mean value was considered for interpretation and it is a reliable and valid tool to measure the strength of upper extremity.

  At baseline and at 6 months

Secondary Outcomes (3)

• Change in Muscle Cross Sectional Area

  At baseline and at 6 months

• Changes in Kinesiophobia

  At baseline and at 6 months

• Changes in Quality of Life

  At baseline and at 6 months

Study Arms (2)

Physical training and high protein diet

OTHER

Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (\>1 g/kg aBW/d).

Other: Physical training and high protein diet

Physical training and low protein diet

OTHER

Subjects in this group underwent integrated physical training for 8 weeks. In addition to the integrated physical training exercises, group B received a low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (\<1 g/kg aBW/d)

Other: Physical training and low protein diet

Interventions

Physical training and high protein diet OTHER

In addition to the integrated physical training exercises, group A received a high protein diet in the range of 1.1 - 1.3 g/kg protein/ ideal body weight/day (\>1 g/kg aBW/d)

Physical training and high protein diet

Physical training and low protein diet OTHER

In addition to the integrated physical training exercises, group B received low protein diet in the range of 0.7 - 0.9 g/kg protein/ ideal body weight/day (\<1 g/kg aBW/d)

Physical training and low protein diet

Eligibility Criteria

• Age: 60 Years - 80 Years
• Gender Eligibility Details: patients with 60 - 80 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Sarcopenia was diagnosed according to the guidelines given by the Asian working group for Sarcopenia (AWGS).
• Appendicular skeletal muscle mass index (ASMI\< 7.0 kg/m2) Patients with less muscle mass, Low handgrip strength (\< 24 kg) Decrease walking speed (\< 0.7 m/sec)

You may not qualify if:

• Subjects with a history of physical workout, Taking medicines Recent surgeries Joint problems in the leg Heart and lung problems Neurological issues Other systemic diseases Contraindications for physical training

Sponsors & Collaborators

• Prince Sattam Bin Abdulaziz University: lead
• Princess Nourah Bint Abdulrahman University: collaborator

Study Sites (1)

Dr. Gopal Nambi

Al Kharj, Riyadh Region, 11942, Saudi Arabia

Location

MeSH Terms

Conditions

Sarcopenia; COVID-19

Interventions

Diet, High-Protein; Diet, Protein-Restricted

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Dr. Gopal Nambi
• Organization: Prince Sattam bin Abdulaziz University

physio_gopal@rediffmail.com

0501878382

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Single-blinded, randomized, experimental study

Study Record Dates

• First Submitted: January 20, 2022
• First Posted: February 4, 2022
• Study Start: March 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: February 17, 2022
• Results First Posted: February 17, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Within one week.
• Access Criteria: IPD can be obtained by contacting principal investigator

Locations

SA (1)