NCT07702227

Brief Summary

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.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
2mo left

Started Jun 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress51%
Jun 2026Sep 2026

Study Start

First participant enrolled

June 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 8, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 21, 2026

Expected
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 8, 2026

Last Update Submit

July 9, 2026

Conditions

Keywords

heart rate variabilitycardiac autonomic functionmulticomponent exercisesix-minute walk testresponder non-responder

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Change in 30-second chair stand test performance

    Baseline and after 12 weeks

  • Change in 8-foot Up-and-Go test performance

    baseline and after 12 weeks

Other Outcomes (1)

  • Change in resting heart rate variability parameters

    Baseline to 12 weeks

Study Arms (2)

multicomponent Exercise group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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.

Interventions

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.

multicomponent Exercise group

Eligibility Criteria

Age60 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Canakkale Onsekiz Mart University

Çanakkale, 17100, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 8, 2026

First Posted

July 14, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

September 21, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations