- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03952104
Strength Training and Quality of Life in Elderly (ST-QOL)
Effects of Different Strength Training Programs on Quality of Life in Elderly
Study Overview
Detailed Description
Background: Physical activity in the elderly has benefits which improve psychological wellbeing. However, the majority of older adults perform less physical activity with advancing age.
Aim: To evaluate the impact of three different 32-week strength training programs (low, moderate and high intensity) on psychological wellbeing of elderly.
Design: Randomized Controlled Trial.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Valencia
-
Moncada, Valencia, Spain, 46113
- Universidad CEU Cardenal Herrera
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age ≥60 years;
- having the ability to speak and write in Spanish;
- having the ability to complete the questionnaires independently.
Exclusion Criteria:
-the presence of any medical problem or pathology that could hinder physical activity practice
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 |
|---|---|
|
No Intervention: Control
No intervention
|
|
|
Experimental: Experimental-Low Intensity Strength Training
Strength training (low intensity)
|
Strength training
|
|
Experimental: Experimental-Moderate Intensity Strength Training
Strength training (moderate intensity)
|
Strength training
|
|
Experimental: Experimental-High Intensity Strength Training
Strength training (high intensity)
|
Strength training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quality of life, assessed through the Short Form 36 health survey questionnaire.
Time Frame: 32 weeks
|
This questionnaire measures quality of live.
It provides information on 8 scales, scoring from 0 (worst health) to 100 (best health), and on the physical component scale (PCS) and the mental component scale (MCS), normalized scores representing overall physical and mental functioning.
|
32 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.
Time Frame: 32 weeks
|
The State-Trait Anxiety Inventory (STAI) is a commonly used measure of trait and state anxiety (Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983).
It can be used in clinical settings to diagnose anxiety and to distinguish it from depressive syndromes.
It also is often used in research as an indicator of caregiver distress.
STAI has 20 items for assessing trait anxiety and 20 for state anxiety.
All items are rated on a 4-point scale (e.g., from "Almost Never" to "Almost Always").
Higher scores indicate greater anxiety.
|
32 weeks
|
|
Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)
Time Frame: 32 weeks
|
This questionnaire consists of 19 items measuring stages on the continuum of self-determination.
It measures external regulation (4 items), introjected regulation (3 items), identified regulation (4 items), intrinsic regulation (4 items), and it adds amotivation (4 items) on a scale from 1 (Not at all true for me) to 5 (Absolutely true for me).
Each of the subscales has a maximum score, with a maximum of 20 for external regulation, identified regulation, intrinsic regulation and amotivation, and 15 for introjected regulation.
|
32 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: JF Lisón, PhD, Cardenal Herrera University
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
Other Study ID Numbers
- UNIVERSITY CARDENAL HERRERA-19
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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