NCT03952104

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable quality-of-life

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 16, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

May 22, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 10, 2020

Completed
Last Updated

July 16, 2020

Status Verified

July 1, 2020

Enrollment Period

1.1 years

First QC Date

May 13, 2019

Last Update Submit

July 15, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life, assessed through the Short Form 36 health survey questionnaire.

    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 Outcomes (2)

  • Emotional wellbeing, assessed through the STAI (State-Trait Anxiety Inventory) questionnaire.

    32 weeks

  • Motivation towards physical activity, assessed through the Behavioural Regulation in Exercise Questionnaire (BREQ-2)

    32 weeks

Study Arms (4)

Experimental-Low Intensity Strength Training

EXPERIMENTAL

Strength training (low intensity)

Other: Strength training

Experimental-Moderate Intensity Strength Training

EXPERIMENTAL

Strength training (moderate intensity)

Other: Strength training

Experimental-High Intensity Strength Training

EXPERIMENTAL

Strength training (high intensity)

Other: Strength training

Control

NO INTERVENTION

No intervention

Interventions

Strength training

Experimental-High Intensity Strength TrainingExperimental-Low Intensity Strength TrainingExperimental-Moderate Intensity Strength Training

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age ≥60 years;
  • having the ability to speak and write in Spanish;
  • having the ability to complete the questionnaires independently.

You may not qualify if:

  • the presence of any medical problem or pathology that could hinder physical activity practice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad CEU Cardenal Herrera

Moncada, Valencia, 46113, Spain

Location

MeSH Terms

Interventions

Resistance Training

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • JF Lisón, PhD

    Cardenal Herrera University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Outcome Assessor Blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Medicine

Study Record Dates

First Submitted

May 13, 2019

First Posted

May 16, 2019

Study Start

May 22, 2019

Primary Completion

July 10, 2020

Study Completion

July 10, 2020

Last Updated

July 16, 2020

Record last verified: 2020-07

Locations