- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07854860
Four-Week Multicomponent Exercise Program in Older Adults
Effects of a 4-Week Multicomponent Exercise Program on Physical Function and Body Composition in Older Adults: A Non-Randomised Controlled Trial
This study evaluated the effects of a four-week supervised multicomponent exercise program on physical function and body composition in older adults. Participants were allocated non-randomly to an intervention group or a control group based on their ability to attend the scheduled training sessions. The intervention group completed eight supervised 30-minute exercise sessions over four weeks, while the control group maintained their usual daily activity and did not begin a new exercise program. Physical function, muscle strength, gait, static balance, body mass, and body composition were assessed at baseline and after four weeks.
Study Overview
Status
Intervention / Treatment
Detailed Description
This prospective, non-randomised controlled intervention study investigated the effects of a short-term multicomponent exercise program in older adults. Participants were allocated to either an intervention group or a control group according to their ability to attend the scheduled training sessions, primarily based on logistical factors such as place of residence and travel feasibility.
The intervention consisted of eight supervised 30-minute training sessions performed twice weekly for four weeks. The program included exercises targeting muscle strength, mobility, balance, coordination, and functional performance. Exercise volume was progressively increased during the second half of the intervention by increasing the number of repetitions and sets.
The control group received no additional exercise intervention and was instructed to maintain usual daily activity and not initiate a new exercise program during the study period. Assessments were performed at baseline and after four weeks and included muscle strength, functional mobility, gait, static balance, body mass, and body composition.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Gorzów Wielkopolski, Poland, 66-400
- Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow Wielkopolski
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Age 55-90 years Ability to ambulate independently without assistance from another person Ability to complete the full study protocol, including baseline and final assessments and, for the intervention group, participation in the four-week exercise program Provision of written informed consent
Exclusion Criteria:
Medical contraindications to physical exertion Cardiovascular, respiratory, neurological, or musculoskeletal conditions that could prevent safe performance of the tests or exercises Musculoskeletal injury or surgery within the previous six months Substantial balance or gait impairments requiring continuous assistance from another person Cognitive impairment preventing comprehension of instructions
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Multicomponent Exercise
Participants completed a four-week supervised multicomponent exercise program consisting of eight 30-minute sessions performed twice weekly. |
A supervised four-week multicomponent exercise program comprising eight 30-minute sessions performed twice weekly. The program included handgrip squeezing with a soft ball, hip flexion with a resistance band, glute bridges, single-leg stance with multidirectional reaching, supine trunk rotation, cervical spine mobility exercises, and stepping over an obstacle. The program was divided into two stages, with progression during weeks 3-4 achieved by increasing the number of repetitions and sets. |
|
No Intervention: Control
Participants received no additional exercise intervention between assessments and were instructed to maintain their usual daily activity levels and not begin a new exercise program. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Handgrip Strength
Time Frame: Baseline to 4 weeks
|
Change in mean bilateral handgrip strength measured with a digital hand dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Isometric Hip Flexion Strength
Time Frame: Baseline to 4 weeks
|
Change in mean bilateral isometric hip flexion strength measured using an EasyForce dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Isometric Hip Extension Strength
Time Frame: Baseline to 4 weeks
|
Change in mean bilateral isometric hip extension strength measured using an EasyForce dynamometer, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Timed Up and Go Test Time
Time Frame: Baseline to 4 weeks
|
Change in time required to complete the Timed Up and Go test, expressed in seconds. |
Baseline to 4 weeks
|
|
Change in Step Length
Time Frame: Baseline to 4 weeks
|
Change in mean bilateral step length measured using the Zebris FDM-THQ instrumented treadmill, expressed in cm. |
Baseline to 4 weeks
|
|
Change in COP Sway Area
Time Frame: Baseline to 4 weeks
|
Change in center-of-pressure sway area measured during 30-second quiet standing using a dual-plate posturographic platform, expressed in mm². |
Baseline to 4 weeks
|
|
Change in Body Mass
Time Frame: Baseline to 4 weeks
|
Change in body mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Estimated Muscle Mass
Time Frame: Baseline to 4 weeks
|
Change in estimated muscle mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Fat Mass
Time Frame: Baseline to 4 weeks
|
Change in fat mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
|
Change in Bone Mass
Time Frame: Baseline to 4 weeks
|
Change in estimated bone mass measured using bioelectrical impedance analysis, expressed in kg. |
Baseline to 4 weeks
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- AWF-SENIORS-44024
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
De-identified individual participant data underlying the reported results are available from the corresponding author upon reasonable request.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.