NCT05705934

Brief Summary

A decrease in muscle mass and function can cause the development of many chronic diseases, including sarcopenia. It has been reported that the best intervention for sarcopenia is exercise. Despite this, the optimal type of exercise for sarcopenia has not yet been determined. Although the holistic approach is used in the literature in the elderly population, it is noticeable that it does not find much space for itself in this patient group. In this study, it was aimed to examine the effects of holistic approach-based exercise program on individuals with sarcopenia.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Status
unknown

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

January 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 31, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2024

Completed
Last Updated

January 31, 2023

Status Verified

January 1, 2023

Enrollment Period

1.4 years

First QC Date

January 20, 2023

Last Update Submit

January 20, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • Muscle Mass

    Muscle ultrasound (US) is a feasible and practical tool to predict sarcopenia. It provides scope for the efficient assessment of muscle quality whilst providing insight into the pathophysiology of sarcopenia in addition to the diagnosis of low muscle mass. US has distinct advantages over other available modalities for muscle mass because the tool allows for separate measurements of individual muscle groups in addition to being safe and portable.

    Change from baseline at 12 weeks

  • The Timed Up&Go Test

    It is a balance test used in the evaluation of functional mobility in the elderly. In the timed up and go (TUG) test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. The elapsed time in this sequence is recorded in seconds. Patients wear their regular footwear and can use a walking aid, if needed.

    Change from baseline at 12 weeks

  • Short Physical Performance Battery (SPPB)

    The short physical performance battery (SPPB) is a group of measures that combines the results of the gait speed, chair stand and balance tests. It has been used as a predictive tool for possible disability and can aid in the monitoring of function in older people. The scores range from 0 (worst performance) to 12 (best performance). A patient's score below 10 is the inclusion criterion for sarcopenia.

    Change from baseline at 12 weeks

Secondary Outcomes (7)

  • SARC-F Questionnaire

    Change from baseline at 12 weeks

  • Charlson Comorbidity Index

    Change from baseline at 12 weeks

  • 30-Second Chair Stand Test

    Change from baseline at 12 weeks

  • Hand Grip Strength

    Change from baseline at 12 weeks

  • Berg Balance Test

    Change from baseline at 12 weeks

  • +2 more secondary outcomes

Study Arms (2)

Group 1

EXPERIMENTAL

Participants in this group will receive holistic-based group exercise program. All evaluations in this group will be done in the form of before and after. The exercise program will be applied for 12 weeks, 3 days a week.

Other: Exercise

Group 2

NO INTERVENTION

Participants in this group will continue their routine habits and nutrition programs. All assessments in this group will be done in the form of before and after.

Interventions

Each session of the exercise program will last 50 minutes and will consist of 4 stages. At these stages, it is aimed to work the social, physical, spiritual and mental parameters of the holistic approach.

Group 1

Eligibility Criteria

Age65 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Being over the age of 65
  • Getting a diagnosis of sarcopenia
  • To be able to walk at least 10 meters independently in public
  • Getting a score of 4 and above from the clock drawing test
  • Volunteer individuals

You may not qualify if:

  • Having a neurological disease
  • Having an uncontrollable cardiopulmonary disease
  • Acute illness that will prevent him/her from understanding and performing the exercises to be performed status or the presence of significant cognitive impairment
  • Providing continuity for less than 80% of the exercise program

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Sarcopenia

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 20, 2023

First Posted

January 31, 2023

Study Start

March 30, 2023

Primary Completion

August 30, 2024

Study Completion

November 30, 2024

Last Updated

January 31, 2023

Record last verified: 2023-01