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Strength Training and Quality of Life in Elderly (ST-QOL)

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ClinicalTrials.gov Identifier: NCT03952104
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Juan F. Lisón Párraga, Dr, Cardenal Herrera University

Brief Summary:
Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.

Condition or disease Intervention/treatment Phase
Quality of Life Other: Strength training Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: Outcome Assessor Blinded
Primary Purpose: Treatment
Official Title: Effects of Different Strength Training Programs on Quality of Life in Elderly
Actual Study Start Date : May 22, 2019
Estimated Primary Completion Date : February 22, 2020
Estimated Study Completion Date : February 23, 2020

Arm Intervention/treatment
Experimental: Experimental-Low Intensity Strength Training
Strength training (low intensity)
Other: Strength training
Strength training

Experimental: Experimental-Moderate Intensity Strength Training
Strength training (moderate intensity)
Other: Strength training
Strength training

Experimental: Experimental-High Intensity Strength Training
Strength training (high intensity)
Other: Strength training
Strength training

No Intervention: Control
No intervention



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03952104


Contacts
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Contact: JF Lisón, PhD 961369000 ext 64349 juanfran@uchceu.es
Contact: Raquel Carcelen, PhD 961369000 ext 64537 raquel.carcelen@uchceu.es

Locations
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Spain
Universidad CEU Cardenal Herrera Recruiting
Moncada, Valencia, Spain, 46113
Contact: JF Lisón, PhD    961369000    juanfran@uchceu.es   
Sponsors and Collaborators
Cardenal Herrera University
Investigators
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Study Director: JF Lisón, PhD Cardenal Herrera University

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Responsible Party: Juan F. Lisón Párraga, Dr, Head of Medicine, Cardenal Herrera University
ClinicalTrials.gov Identifier: NCT03952104     History of Changes
Other Study ID Numbers: UNIVERSITY CARDENAL HERRERA-19
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No