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

NCT ID: NCT05224453

Last Updated: 2022-02-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-11-30

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.

Detailed Description

It is a single-blinded, randomized, experimental study performed from March -2020 to November-2021. The trial received acceptance from the department of the ethical committee (DEC), Prince Sattam bin Abdulaziz University, Al-Kharj, Saudi Arabia with an approval number of RHPT/020/51. The DEC approved the subject consent form, treatment protocols, and the outcome parameters measured in the trial. The trial was executed in accordance with the ethical guidelines laid down in the 1964 Declaration of Helsinki. The finally selected subjects for the trial were asked to fill out the written subject consent form and underwent measurements for pre-interventional personal and anthropometric data. A two-block simple random sampling method was used to randomize and allocated the participants into two treatment groups. Group A was treated with integrated physical training with a high protein diet (n = 38) and group B was treated with the same integrated physical training with a low protein diet (n = 38) for a duration of eight weeks.

Subjects' personal and anthropometric measurements were calculated through Kolmogorov-Smirnov test for testing homogeneity and the data were represented in tabular form. The measurements were taken before the intervention, during the intervention at 4 weeks, after intervention at 8 weeks and after 6 months follow up. The data were shown as mean and standard deviation with 95% confidence interval (CI) with upper and lower limits. The time and group (4 × 2) multiple analysis of variance (MANOVA) of primary and secondary variables are reported between group A and group B at various intervals. The student's t-test was used to calculate inter-group effects and repeated measures (rANOVA) were used to calculate the intra-group effects. IBMSPSS - online version 20 was used to do all the statistical tests and the α level was set at 0.05.

Conditions

Sarcopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Physical training and high protein diet

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).

Group Type: OTHER

Physical training and high protein diet

Intervention Type: 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 low protein diet

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)

Group Type: OTHER

Physical training and low protein diet

Intervention Type: 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)

Interventions

Physical training and high protein diet

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)

Intervention Type: OTHER

Physical training and low protein diet

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)

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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)

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Princess Nourah Bint Abdulrahman University

OTHER

Sponsor Role: collaborator

Prince Sattam Bin Abdulaziz University

OTHER

Sponsor Role: lead

Responsible Party

Gopal Nambi

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Dr. Gopal Nambi

Al Kharj, Riyadh Region, Saudi Arabia

Countries

Saudi Arabia

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

RHPT/020/051

Identifier Type: -

Identifier Source: org_study_id