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Motivational Resistance-training Program on Adherence and Body Composition in Elderly

Primary Purpose

Motivation, Body Weight

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motivational resistance-training programme
Sponsored by
Universidad Católica San Antonio de Murcia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Motivation focused on measuring elderly, motivation, adherence, resistance-training, health

Eligibility Criteria

65 Years - 75 Years (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Never previously attended classes in fitness academies or were not currently performing regular physical activity, and had no previous experience with resistance-training programmes

Exclusion Criteria:

  • Any history of neuromuscular, metabolic, hormonal or cardiovascular diseases; not taking any medication that could influence hormonal and neuromuscular metabolism.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    training group

    control group

    Arm Description

    The training group, based on motivational strategies were performed and a moderate intensity training (8 to 12 repetitions). The load was increased: during the 12 weeks from 65% 1-RM to 80% 1-RM, performing individual more than the prescribed number of repetitions (12 repetitions). A 1-2 minutes resting period was allowed between sets. There was no attempt to control the velocity of the repetitions performed. Prior to each training session, the volunteers performed a specific warmup, consisting of 10 repetitions with approximately 50% of the load used in the first and second exercises of the training session. A total of 36 sessions were performed during the training period. This group was compared with no interventions subjects.

    The control group, did not participate in the motivational resistance-training program.

    Outcomes

    Primary Outcome Measures

    Change of behavioural regulation during exercise
    To evaluate the type of motivational regulation related to physical exercise. The Spanish version of Behavioural Regulation during Exercise Questionnaire was used. This questionnaire allows to 13 evaluate the type of motivational regulation related to physical exercise, and consists in 14 23 items distributed in three dimensions, based on the established distinction in the SDT 15 between autonomous motivation, controlled motivation and demotivation.
    Change of basic psychological needs during exercise.
    To assess the perceived need satisfaction of the participant. satisfaction of the participants, the Spanish adaptation of the Basic Psychological Needs 4 in Exercise Scale was used. The questionnaire includes 12 items distributed in three 6 dimensions.

    Secondary Outcome Measures

    Change of body weight (kg)
    After removal of shoes and heavy outer clothing,using a Tanita BC-418 MA scale, (Tanita Corporation, Arlington Heights, IL) to the 24 nearest 0.1 kg
    Change of standing height (cm)
    Assessed without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
    Change of Body Mass Index (BMI): (kg/m^2)
    was calculated as the ratio of weight to squared height
    Change of bioelectrical impedance Muscle mass (kg)
    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.
    Change of bioelectrical impedance Fat mass (%)
    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.

    Full Information

    First Posted
    June 19, 2017
    Last Updated
    June 26, 2017
    Sponsor
    Universidad Católica San Antonio de Murcia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03201081
    Brief Title
    Motivational Resistance-training Program on Adherence and Body Composition in Elderly
    Official Title
    Impact of a Motivational Resistance-training Program on Adherence and Body Composition in Elderly
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    January 15, 2017 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    June 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica San Antonio de Murcia

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Lack of physical activity is one of the major causes for obesity and functional disability in the elderly. Including regular exercise in elderly´s lifestyle is not an easy task. The main objective was to analyse the effect of a motivational resistance-training programme on satisfying the individual´s psychological needs, level of self-determination and body composition. A quasi-experimental study was performed with 47 volunteers (29 females, 18 males) of 67-75 years of age, divided into two groups: experimental (n = 27) and control (n = 20). A 12-week intervention programme was performed, with a total of 36 sessions.
    Detailed Description
    Material and Methods Participants The study included a total of 47 subjects, (29 females, 18 males) ages 65 to 75 years, recruited from an elderly social club. The participants were divided into two groups: experimental group (n=27; 10 men and 17 female) and control group (n=20; 8 men and 12 female). The sampling was natural and intentional. All subjects originated from Murcia (Spain) and met the following inclusion criteria: had never previously attended classes in fitness academies or were not currently performing regular physical activity, and had no previous experience with resistance-training programmes. Exclusion criteria included any history of neuromuscular, metabolic, hormonal or cardiovascular diseases; not taking any medication that could influence hormonal and neuromuscular metabolism. In addition, the participants were advised to not alter their diet during the study. Participants were informed about the possible risks and discomforts that could arise and were asked to complete a health history questionnaire and sign a consent form. The current study was approved of the Ethics Committee of the Catholic University San Antonio of Murcia (Spain) following the guidelines of the Helsinki Declaration. Design A quasi-experimental design (2x2) was developed, dividing the participants into two groups; one experimental and one control. In this design, an initial measurement prior to the intervention (pre-test) and a measurement after the intervention (post-test) were conducted. This same research design has been used in previous studies, which has sought to assess the effect of an intervention programme on body composition, motivational variables and resistance-training. Data Collection and Procedure Motivational variables Behavioural regulation during exercise. The Spanish version of Behavioural Regulation during Exercise Questionnaire was used. This questionnaire allows to evaluate the type of motivational regulation related to physical exercise, and consists in 23 items distributed in three dimensions, based on the established distinction in the SDT between autonomous motivation, controlled motivation and demotivation. Autonomous motivation was calculated using the mean score of intrinsic regulation (e.g. "Because I think that exercise is fun"), integrated regulation (e.g. "Because I believe that physical exercise is consistent with my values") and identified regulation (e.g. "I value the benefits of exercise"). Each of these regulations was composed of 4 items, except for the identified regulations which was composed of 3 items. Controlled motivation was calculated using the mean score of introjected regulation (e.g. "I feel guilty when I don't exercise") and external regulation (e.g. "I feel under pressure from my friends/family to exercise") with 4 items each. Demotivation (e.g. "I don't see why I should have to exercise") was also calculated using 4 items. Previous research in the physical activity and health context demonstrated the internal reliability of the instrument. Basic psychological needs during exercise. To assess the perceived need satisfaction of the participants, the Spanish adaptation of the Basic Psychological Needs in Exercise Scale was used (BPNES), which is specific for the context of physical activity and health.67 The questionnaire includes 12 items distributed in three dimensions. Four items measure autonomy (e.g. "I exercise according to what I intend to do"), four items measure competence (e.g. "I feel that physical exercise is an activity that I do very well") and the other four items measure relatedness (e.g. "I have a close relationship with the people with whom I exercise"). Previous research in the physical activity and health context demonstrated the internal reliability of the instrument. The answers to the questionnaires were assessed on a Likert scale ranging from 1 to 7, where one corresponded with the anchor statement "strongly disagree" and seven with the anchor statement "strongly agree". Before carrying out the intervention, the main researcher contacted with the director of the social club to inform of the purpose of the study. Likewise, all the participants involved were informed about the process that they were going to follow, emphasizing that participation was voluntary. The researcher overviewed how to complete the questionnaire and answered any questions that arose during the process. The different questionnaires were completed in an adequate climate of concentration, with each participant taking approximately 15-20 minutes to complete the questionnaires. Body composition variables Total body weight was measured, after removal of shoes and heavy outer clothing, using a Tanita BC-418 MA scale, (Tanita Corporation, Arlington Heights, IL) to the nearest 0.1 kg.69 Standing height without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm. To minimize the potential source of Bioimpedance systems (BIA) related to total body weight and height, body composition assessment was performed by a level two anthropometrist following International Society for the Advancement of Kinanthropometry recommendations.70 Body Mass Index (BMI) was calculated as the ratio of weight to squared height. BMI was categorized into underweight (<18.50 kg/m2), normal weight (18.50-24.99 kg/m2), overweight (25.00-29.99 kg/m2), and obese (30.00 kg/m2). Bioelectrical impedance was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles. Fat mass (FM) and muscle mass (MM) were then calculated, using the prediction equation described by Jebb et al. Bioelectrical impedance was chosen due to its ease of use and less invasive nature, making it suitable for assessment of body composition in vulnerable populations such as obese individuals and elderly. Multi-dimensional intervention programme Prior to the commencement of the study, the subjects were submitted to two weeks of training, two sessions per week, in order to be familiarized with the resistance-training exercises performed in the current study. During this familiarization period, a higher emphasis was placed on learning the proper exercise techniques, and brief pauses between repetitions were allowed in order to reset their starting positions when necessary. During the second week of the familiarization period, a pre-test of the motivational variables was performed, as well as measuring weight, height, BMI, FM and MM. Both pre-test and post-test were carried out in one day between 8:00 and 9:00 a.m. After the pre-test, the experimental group underwent a resistance-training programme for 12 weeks, where different motivational strategies were used. The resistance-training programme incorporated resistance exercises of six major regions and consisted in 3 training sessions per week on non-consecutive days (Monday, Wednesday, and Friday). The six regions were chest, back, triceps, biceps, shoulders and legs. The different regions were grouped into a circuit. The control group, on the other hand, did not participate in the resistance-training programme. The experimental group exercised at a moderate intensity (8 to 12 repetitions). The load was increased during the 12 weeks from 65% 1-RM to 80% 1-RM. This training load was increased when the individual could perform more than the prescribed number of repetitions (12 repetitions), following the OMNI-RES scale and a hard effort perception level. A 1-2 minutes resting period was allowed between sets. All training sessions were monitored by an experienced physical education professional and the subjects were not allowed to perform any additional exercises during the training period. During the training weeks, participants were instructed not to change dietary habits or perform additional non-resistance-training related physical activity. In addition, with the objective of increasing the adherence to the resistance-training programme, a series of motivational strategies were performed. The strategies to motivation assessment used were based on the principles of the Self-Determination Theory (SDT). SDT includes a meta-theory for framing motivational studies, a formal theory that defines intrinsic and varied extrinsic sources of motivation, their role in cognitive and social development, as well as in individual differences. SDT is a theory of motivation and personality that addresses three universal, innate and basic psychological needs: autonomy, competence and relatedness. During the resistance-training programme, the subjects received verbal motivational strategies, based on previous studies which have proven the beneficial effect they exert on BPN satisfaction and autonomous motivation.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Motivation, Body Weight
    Keywords
    elderly, motivation, adherence, resistance-training, health

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A quasi-experimental design (2x2) was developed, dividing the participants into two groups; one experimental and one control. In this design, an initial measurement prior to the intervention (pre-test) and a measurement after the intervention (post-test) were conducted. The sampling was natural and intentional.
    Masking
    Investigator
    Allocation
    Non-Randomized
    Enrollment
    47 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    training group
    Arm Type
    Experimental
    Arm Description
    The training group, based on motivational strategies were performed and a moderate intensity training (8 to 12 repetitions). The load was increased: during the 12 weeks from 65% 1-RM to 80% 1-RM, performing individual more than the prescribed number of repetitions (12 repetitions). A 1-2 minutes resting period was allowed between sets. There was no attempt to control the velocity of the repetitions performed. Prior to each training session, the volunteers performed a specific warmup, consisting of 10 repetitions with approximately 50% of the load used in the first and second exercises of the training session. A total of 36 sessions were performed during the training period. This group was compared with no interventions subjects.
    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group, did not participate in the motivational resistance-training program.
    Intervention Type
    Other
    Intervention Name(s)
    Motivational resistance-training programme
    Intervention Description
    The experimental group exercised at a moderate intensity (8 to 12 repetitions). The load was increased during the 12 weeks from 65% 1-RM to 80% 1-RM. This training load was increased when the individual could perform more than the prescribed number of repetitions (12 repetitions), following the OMNI-RES scale and a hard effort perception level.74 A 1-2 minutes resting period was allowed between sets. During the sessions, the participants were verbally encouraged to perform the complete range of motion for each exercise and received motivational strategies.
    Primary Outcome Measure Information:
    Title
    Change of behavioural regulation during exercise
    Description
    To evaluate the type of motivational regulation related to physical exercise. The Spanish version of Behavioural Regulation during Exercise Questionnaire was used. This questionnaire allows to 13 evaluate the type of motivational regulation related to physical exercise, and consists in 14 23 items distributed in three dimensions, based on the established distinction in the SDT 15 between autonomous motivation, controlled motivation and demotivation.
    Time Frame
    Change from Baseline behavioural regulation during exercise at 12 weeks
    Title
    Change of basic psychological needs during exercise.
    Description
    To assess the perceived need satisfaction of the participant. satisfaction of the participants, the Spanish adaptation of the Basic Psychological Needs 4 in Exercise Scale was used. The questionnaire includes 12 items distributed in three 6 dimensions.
    Time Frame
    Change from Baseline Basic psychological needs during exercise at 12 weeks
    Secondary Outcome Measure Information:
    Title
    Change of body weight (kg)
    Description
    After removal of shoes and heavy outer clothing,using a Tanita BC-418 MA scale, (Tanita Corporation, Arlington Heights, IL) to the 24 nearest 0.1 kg
    Time Frame
    Change from Baseline body weight (kg) at 12 weeks
    Title
    Change of standing height (cm)
    Description
    Assessed without shoes was measured using a Seca 202 stadiometer (Seca, Hamburg, Germany) to the nearest 0.1 cm.
    Time Frame
    Change from Baseline standing height (cm) at 12 weeks
    Title
    Change of Body Mass Index (BMI): (kg/m^2)
    Description
    was calculated as the ratio of weight to squared height
    Time Frame
    Change from Baseline Body Mass Index (BMI): (kg/m^2) at 12 weeks
    Title
    Change of bioelectrical impedance Muscle mass (kg)
    Description
    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.
    Time Frame
    Change from Baseline bioelectrical impedance Muscle mass (kg) at 12 weeks
    Title
    Change of bioelectrical impedance Fat mass (%)
    Description
    Was measured using the Tanita BC-418 MA scale, with participants standing barefooted on the analyser's footpads, and holding its handles.
    Time Frame
    Change from Baseline bioelectrical impedance fat mass (kg) at 12 weeks

    10. Eligibility

    Sex
    All
    Gender Based
    Yes
    Gender Eligibility Description
    older people
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Never previously attended classes in fitness academies or were not currently performing regular physical activity, and had no previous experience with resistance-training programmes Exclusion Criteria: Any history of neuromuscular, metabolic, hormonal or cardiovascular diseases; not taking any medication that could influence hormonal and neuromuscular metabolism.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Motivational Resistance-training Program on Adherence and Body Composition in Elderly

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