Functional and Physiological Responses to Multicomponent Exercise in Older Adults

Functional and Physiological Responses to a 12-Week Multicomponent Exercise Program in Older Adults: An Exploratory Responder-Non-Responder Analysis

This study will examine functional and physiological responses to a 12-week multicomponent exercise program in community-dwelling older adults. Adults aged 60 to 81 years will be randomly assigned to either a multicomponent exercise group or a control group. The supervised exercise program will be performed twice weekly for 12 weeks and will include aerobic walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Functional performance will be assessed using the six-minute walk test, the 30-second chair stand test, and the 8-Foot Up and Go test at baseline and after 12 weeks. Resting cardiac autonomic function will be assessed using heart rate variability. In addition, an exploratory responder-non-responder analysis will be conducted to examine whether baseline heart rate variability is associated with individual functional adaptations following the exercise program. This study may help identify physiological markers related to functional responsiveness to exercise in older adults.

Study Overview

• Status: Active, not recruiting
• Conditions: Aging; Functional Capacity; Exercise Response; Heart Rate Variability (HRV); Older Adults (60 - 85 Years Old)
• Intervention / Treatment: Behavioral: Multicomponent Exercise Program

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Çanakkale, Turkey (Türkiye), 17100
    • Canakkale Onsekiz Mart University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• being 60 years of age or older,
• being able to walk independently,
• not having any serious cardiovascular, neurological, or musculoskeletal disease that would prevent exercise.
• do not use medications that may affect autonomic nervous system function

Exclusion Criteria:

• diagnosed cardiac arrhythmia,
• uncontrolled hypertension,
• use of medications that may affect autonomic nervous system function,
• inability to perform functional performance tests.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: multicomponent Exercise group; Participants are assigned to either a 12-week supervised multicomponent exercise group or a control group. Outcomes are assessed at baseline and after the 12-week intervention period.	Behavioral: Multicomponent Exercise Program; Participants in the exercise group will complete a supervised multicomponent exercise program twice weekly for 12 weeks. Each session will last approximately 45 to 50 minutes and include warm-up, aerobic interval walking, resistance exercises, balance and agility training, flexibility exercises, and cool-down activities. Exercise intensity will be monitored using the Borg Rating of Perceived Exertion scale and exercise difficulty will be progressively increased by increasing repetitions, walking duration, walking pace, and task complexity.
No Intervention: Control Group; Participants in the control group will maintain their usual daily activities during the 12-week study period and will not receive the supervised multicomponent exercise program.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in six-minute walk distance	Functional walking capacity will be assessed using the six-minute walk test. The total distance walked in six minutes will be recorded in meters at baseline and after the 12-week intervention.	Baseline and 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 30-second chair stand test performance	Lower-limb functional strength will be assessed using the 30-second chair stand test at baseline and after the 12-week intervention.	Baseline and after 12 weeks
Change in 8-foot Up-and-Go test performance	Functional mobility and agility will be assessed using the 8-Foot Up-and-Go test at baseline and after the 12-week intervention.	baseline and after 12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in resting heart rate variability parameters	Resting heart rate variability parameters will be assessed at baseline as pre-specified exploratory physiological markers associated with individual functional responses to the exercise program.	Baseline to 12 weeks

Collaborators and Investigators

• Sponsor: Çanakkale Onsekiz Mart University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2026
• Primary Completion (Estimated): September 21, 2026
• Study Completion (Estimated): September 30, 2026

Study Registration Dates

• First Submitted: July 8, 2026
• First Submitted That Met QC Criteria: July 9, 2026
• First Posted (Actual): July 14, 2026

Study Record Updates

• Last Update Posted (Actual): July 14, 2026
• Last Update Submitted That Met QC Criteria: July 9, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: heart rate variability; six-minute walk test; multicomponent exercise; cardiac autonomic function; responder non-responder
• Other Study ID Numbers: 2026-YONP-0121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No