- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07680036
Resistance Training and Capillarization - Role on the Anabolic Response in Older Adults (RECAP)
RESISTANCE TRAINING AND CAPILLARIZATION - ROLE ON THE ANABOLIC RESPONSE IN OLDER ADULTS
Ecco una versione strutturata secondo il template ClinicalTrials.gov:
The goal of this clinical trial is to learn how muscle capillaries influence the response to resistance exercise training in older adults. The study will include older men and women who may experience age-related declines in muscle mass and function. The main questions it aims to answer are:
- Does baseline muscle capillarization influence the increase in muscle size and function following resistance exercise training?
- Can resistance exercise stimulate the formation of new capillaries in older adults with lower baseline capillarization, and how is this related to muscle growth?
Participants will:
- Undergo assessments of muscle structure, capillarization, and physical function before and after the intervention.
- Participate in a supervised resistance exercise training program.
- Provide muscle samples and other physiological measurements to evaluate changes in muscle growth and blood vessel formation.
Researchers will analyze the relationship between baseline muscle capillarization, exercise-induced angiogenesis, and improvements in muscle mass and function to better understand why some older adults respond more effectively to resistance exercise than others.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Per la sezione **Detailed Description** di ClinicalTrials.gov conviene essere molto più sintetici rispetto al protocollo operativo, evitando di duplicare dettagli che compariranno in *Arms and Interventions* e *Outcome Measures*.
This randomized clinical trial will investigate the effects of different exercise training strategies on skeletal muscle adaptations in older adults. Participants will be randomly assigned to one of three training groups and will complete a supervised 12-week exercise program, consisting of three sessions per week.
The interventions will include different combinations and sequencing of resistance and aerobic exercise during the first 8 weeks of training, followed by a standardized resistance training program during the final 4 weeks. The study is designed to determine whether the timing and type of exercise influence muscle growth, vascular adaptations, and functional outcomes.
Participants will undergo assessments before the intervention and after 4, 8, and 12 weeks of training. Measurements will include body composition, muscle size and architecture, muscle strength, aerobic fitness, and physical function. A subgroup of participants may also undergo optional muscle biopsies to evaluate changes in muscle capillarization and biological markers associated with muscle adaptation.
The results will help identify exercise strategies that optimize muscle and vascular adaptations in older adults and improve understanding of the mechanisms underlying individual variability in training responsiveness.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
PD
-
Padova, PD, Italy, 35131
- Nutrition and Exercise Lab, DSB
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 65 years
- Body Mass Index (BMI) >18 and <30 kg/m²
- Stable body weight for at least 3 months prior to enrollment
Exclusion Criteria:
- Prediabetes or diabetes according to ADA criteria
- Chronic diseases, including cardiovascular, liver, respiratory diseases, or cancer
- Acute inflammatory conditions, infections, or other clinically significant illnesses
- Regular participation in vigorous physical activity (≥2 sessions per week)
- Current or recent (within the previous 3 months) treatment with steroid medications
- Regular use of protein supplements
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: RRR
Effect of 3 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
|
Active Comparator: ARR
Effect of 1 month of aerobic training followed by 2 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
|
Active Comparator: RAR
Effect of the combination of 1 month of resistance training followed by 1 month of aerobic training and 1 months of progressive resistance training on muscle adaptation in older adults
|
2 months of different combination of aerobic and resistance training before undergoing to 1 month of resistance training at 80% 1RM
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
muscle hypertrophy
Time Frame: 3 months
|
difference of kilograms of Lean Body Mass from baseline measured by DEXA
|
3 months
|
|
capillary density
Time Frame: 3 month
|
change on the number of capillary per muscle fiber measured histochemically trought muscle biopsy.
|
3 month
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- RECAP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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.
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