NCT05593471

Brief Summary

this study aims to compare the effect of high-intensity resistance exercises measured using the 10-repetition maximum versus low-intensity aerobic exercises on muscle performance, physical function and quality of life in chronic kidney patients with sarcopenia who recently recovered from COVID-19 infection

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 25, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 19, 2023

Completed
Last Updated

March 21, 2023

Status Verified

March 1, 2023

Enrollment Period

2 months

First QC Date

October 20, 2022

Last Update Submit

March 19, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life (SAR QoL) questionnaire used to assess the quality of life experienced by sarcopenia patients

    In order to measure the quality of life, we used the SarQoL® questionnaire, which is a valid, consistent, and reliable, and can therefore be recommended for clinical and research purposes (Beaudart et al., 2017).

    6 weeks

Secondary Outcomes (3)

  • Physical function:

    6 weeks

  • Muscle power:

    6 weeks

  • Muscle strength

    6 weeks

Study Arms (2)

High intensity exercises

EXPERIMENTAL

The first group (HG) received a High-intensity exercise program consisting of progressive resistance training for 30 min using dumbbells, sandbags, and TheraBand with different colors. The exercised muscles were (knee extensors, elbow flexors, chest muscles, hip adductors, abductors, abdominal muscles, back muscles, and hand grip muscles) (references). The intensity of exercise was determined by the load which was kept at 65% of the 10-repetition maximum throughout the program duration. The repetitions of each exercise were kept at a fixed value of 2 sets of 10 - 12 repetitions per session (exercises stopped if the patient reached fatigue level). For progression, the 10-repetition maximum test was performed on a weekly schedule and the amount of load was adjusted accordingly. Exercises were done in a cyclic manner where half of the selected muscles were exercised per session and the other half were exercised in the next session.

Other: high intensity exercises

low intensity aerobic exercises

EXPERIMENTAL

The second group (LG) received a low-intensity aerobic exercise program consisting of an arm ergometer, and a bicycle ergometer to train both upper and lower body muscles. Additionally, 5 minutes of regular treadmill walking was added at the beginning and the end of the exercises session as warming up and cooling down respectively. Exercises were performed in a cyclic manner where the arm and bicycle ergometers were used alternatively. The rate of perceived exertion (RPE) scale was used to monitor the intensity of the exercises to be at 3 -4 level. The actual working out time was 20 minutes plus 10 minutes for the warming up and cooling down. Sessions were performed 3 times per week for six weeks.

Other: low intensity aerobic exercises

Interventions

resistance training progressively increasing according to specific criteria (10 repetitions maximum). for the major muscles of the body

Also known as: progressive resistance training
High intensity exercises

low-intensity exercises performed using arm or leg ergometer machines

Also known as: aerobic exercises
low intensity aerobic exercises

Eligibility Criteria

Age30 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Both sexes with age between 50 - 70 years old.
  • CKD stages (3 and 4)
  • Infected by COVID-19 and recovered (1 - 2 months)
  • Score of 4 or more on SAR-QoL Questionnaire
  • Patients having had a medical prescription for physical rehabilitation.

You may not qualify if:

  • Patients infected again by -CoVID-19
  • Any serious inflammatory, neurological, or cardiovascular diseases.
  • Chronic chest disease.
  • Chronic inflammatory orthopedic disorders and rheumatoid arthritis.
  • Mental impairments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid Hospital

Hail, Saudi Arabia

Location

MeSH Terms

Conditions

Sarcopenia

Interventions

High-Intensity Interval TrainingExercise

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

October 20, 2022

First Posted

October 25, 2022

Study Start

January 15, 2023

Primary Completion

March 15, 2023

Study Completion

March 19, 2023

Last Updated

March 21, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations