Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 13, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date  ICMJE May 22, 2019
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03952104 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 16, 2019)
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • Emotional wellbeing, assessed through the short form of the Profile of Mood States (POMS) questionnaire. [ Time Frame: 32 weeks ]
    This questionnaire requires individuals to describe how they feel "right now" via responses to 29 single-word mood descriptor items along a 5-point Likert-type scale ranging from 0 (Not at all) to 4 (Extremely) to evaluate five subscales, four of them negative: depression (6 items evaluating feelings of worthlessness, sadness, guilt and emotional isolation from others), anger (7 items about the existence of feelings of anger and hostility), tension (6 items measuring musculoskeletal and somatic tension), fatigue (5 items to measure states of abatement, inertia, and low energy levels); and one positive: vigour (5 items evaluating a mood of vigorousness, euphoria and high energy). Each of the subscales has a maximum score, with a maximum of 24 for depression and tension, 20 for vigour and fatigue, and 28 for anger.
  • 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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Strength Training and Quality of Life in Elderly
Official Title  ICMJE Effects of Different Strength Training Programs on Quality of Life in Elderly
Brief Summary Aim: To evaluate the impact of three different strength training programs on psychological wellbeing of elderly.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description:
Outcome Assessor Blinded
Primary Purpose: Treatment
Condition  ICMJE Quality of Life
Intervention  ICMJE Other: Strength training
Strength training
Study Arms  ICMJE
  • Experimental: Experimental-Low Intensity Strength Training
    Strength training (low intensity)
    Intervention: Other: Strength training
  • Experimental: Experimental-Moderate Intensity Strength Training
    Strength training (moderate intensity)
    Intervention: Other: Strength training
  • Experimental: Experimental-High Intensity Strength Training
    Strength training (high intensity)
    Intervention: Other: Strength training
  • No Intervention: Control
    No intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
80
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 23, 2020
Estimated Primary Completion Date February 22, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: JF Lisón, PhD 961369000 ext 64349 juanfran@uchceu.es
Contact: Raquel Carcelen, PhD 961369000 ext 64537 raquel.carcelen@uchceu.es
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03952104
Other Study ID Numbers  ICMJE UNIVERSITY CARDENAL HERRERA-19
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Juan F. Lisón Párraga, Dr, Cardenal Herrera University
Study Sponsor  ICMJE Cardenal Herrera University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: JF Lisón, PhD Cardenal Herrera University
PRS Account Cardenal Herrera University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP