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Individualized Exercise Program Plus Behavioral Change Enhancement Strategies for Managing Fatigue in Frail Older People

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ClinicalTrials.gov Identifier: NCT03394495
Recruitment Status : Recruiting
First Posted : January 9, 2018
Last Update Posted : August 7, 2018
Sponsor:
Information provided by (Responsible Party):
Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University

Brief Summary:

This project aims to investigate the effects of an individualized exercise programme with and without BCE strategies for community-dwelling frail older people with general fatigue, so as to reduce their fatigue and improve their physical endurance, exercise self-efficacy, and habitual physical activity, while reducing their symptoms of frailty.

Twelve district community health centres will be randomized to one of the three study groups: the combined (COMB) group, receiving the 16-week combined intervention consisting of individualized exercise training and Behavioural Change Enhancement programmes plus two booster sessions at 2 and 6 months after the programme; the exercise (EXER) group, receiving exercise training and health talks only; or the control group, receiving health talks only. Participants from each centre will be placed in their centre's corresponding group.

It is hypothesized that the COMB group will achieve a significantly greater reduction in fatigue and a greater improvement in their physical endurance, exercise self-efficacy, and habitual physical activity, and a significantly greater reduction in their frailty symptoms, when compared with the EXER and control groups at 1 week and 6 and 12 months after completing the interventions.


Condition or disease Intervention/treatment Phase
Fatigue Other: BCE Combination group Not Applicable

Detailed Description:

All twelve community centres, which provide similar types of community care and social support services for community-dwelling older people, have been invited by a convenience method to work as collaborators in this study. The target population of this study are community-dwelling frail older people with general fatigue with a nonspecific cause who will be recruited through the community centres. Using computer-generated random numbers, a biostatistician not affiliated with this study will randomize the centres into either: control, EXER, or COMB. The number of participants recruited in each centre will be in proportion to the size of the centre.

Participants allocated to the COMB group will receive a 16-week programme with a combination of the BCE programme and exercise training. The BCE programme is designed based on the Health Action Process Approach (HAPA) model and was piloted by the principal investigator, which aims to motivate the participants to develop the intention to actively manage their fatigue; and to encourage them to gradually exceed the perceived limits of their energy and to recondition their bodies by participating in exercise according to their individual exercise regimens. The BCE programme consists of three phases (the goal initiation, plan formulation and action execution) with 6 face-to-face 1-hour sessions plus two booster BCE sessions at 2 and 6 months after the programme.

For the exercise training, a weekly 45-60 minute centre-based exercise programme, which is designed according to the American Heart Association's recommendations on exercise for older people will be arranged from weeks 4-16 during the execution phase. The exercise sessions consist of balance training, resistance exercises, and aerobic training. All participants will receive circuit training with set exercises, but the dosage of different components will be tailor-made for each participant by a physiotherapist after having their physical conditions examined.

The EXER group will receive a 16-week programme with a combination of exercise training and centre-based health talks on the management of different health issues with the exception of fatigue.

The control group will attend centre-based health talks only.

The number and timing of the health talks for the other two groups will be similar to those in the BCE sessions.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 285 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: A three-arm parallel (single-blinded) cluster randomized controlled trial involves three groups of participants (the COMB, the EXER and the control group). Twelve community health centres that provide similar types of community care and social support services for community-dwelling older people, have been invited by a convenience method to work as collaborators in this study. Using computer-generated random numbers, a biostatistician not affiliated with this study will randomize the centres into either: control, EXER, or COMB group. So during the trial, participants in one group receive combination intervention "in parallel" to participants in the other two groups (the control group and the exercise group).
Masking: Single (Outcomes Assessor)
Masking Description: An independent assessor who is blinded to the group allocations will assess the participants' outcomes.
Primary Purpose: Treatment
Official Title: Evaluation of an Individualized Exercise Programme Plus Behavioural Change Enhancement Strategies for Managing General Fatigue in Community-dwelling Frail Older People: A Cluster-randomized Controlled Trial.
Actual Study Start Date : February 26, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: BCE Combination group

16-week BCE programme with exercise training.

Six 1-hour sessions of BCE programme and a weekly 45-60 minute centre-based exercise programme from week 4 to week 16.

Other: BCE Combination group
The combination intervention programme consists of a weekly exercise training sessions and 6 sessions of Behavioral Change Enhancement (BCE) programme.

No Intervention: Exercise group

16-week programme with health talks and exercise training.

Six 1-hour sessions of health talks and a weekly 45-60 minutes centre-based exercise programme from week 4 to week 16.

No Intervention: Control group
Six sessions of centre-based health talks on the management of different health issues with the exception of fatigue.



Primary Outcome Measures :
  1. Participants' level of fatigue will be assessed using the 20-item Chinese Multidimensional Fatigue Inventory (CMFI-20) [ Time Frame: To detect the change from baseline total fatigue score at mid-term programme (i.e. wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    CMFI-20 consists of 20 items, each item is rated on a 5-point Likert scale from 1=strongly agree to 5 = strongly disagree, with all items summed to get the total score which ranges from 20-100, a higher score indicates more fatigue.


Secondary Outcome Measures :
  1. Participants' lower-limb strength will be assessed using the 30-second chair stand test [ Time Frame: To detect the change from baseline lower-limb strength at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    Participants will be asked to stand up and sit down as many as they can within 30 seconds on a standard chair. The total number of standing up from a chair will be counted. More number indicates better lower-limb strength

  2. Participants' upper-limb strength will be assessed using a handheld Jamar Hydraulic Hand Dynamometer [ Time Frame: To detect the change from baseline upper-limb strength in kg at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    It will be measured by handheld Jamar Hydraulic Hand Dynamometer with kilogram (kg). Greater force in kg indicates better upper-limb strength

  3. Participants' functional mobility will be measured by the timed-up-and-go-test [ Time Frame: To detect the change from baseline time to complete the "timed-up-and-go-test" at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    Record the time in second that participants complete the timed up and go test to indicate their functional mobility

  4. Participants' gait speed will be measured by the 6 meter walk test [ Time Frame: To detect the change from baseline gait speed at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after the completion of the programme ]
    Record the time in second that participants complete the 6 meter walk test to indicate the their gait speed.

  5. Participants' exercise self-efficacy will be measured using Chinese Self-Efficacy for Exercise (CSEE) scale [ Time Frame: To detect the change from baseline total CSSE score at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    The CSEE scale contains of 9 items. Each item is rated on 11-point Liker scale from 0 = no confidence to 10 = full of confidence. All item scores are summed to get the total score which ranges from 0 to 90 with a higher score indicates higher exercise self-efficacy

  6. Participants' frailty level will be assessed using Fried Frailty Index (FFI) [ Time Frame: To detect the change from baseline frailty level at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after the completion of the programme ]
    Fried Frailty Index includes: i) an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced handgrip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., < 30 for men and < 27.7 for women).

  7. Physical activity will be assessed using the Physical Activity Scale for the Elderly-Chinese (PASE-C) [ Time Frame: To detect the change from baseline PASE-C total score at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after completing the programme ]
    The PASE-C is a self-reported scale for evaluating the level of physical activity of older people over a 1-week period. It consists of 12-items to explain three levels of activities: leisure time activity, household activity and work-related activity. Basic descriptions are:1) 5-items under the leisure time activity are rated on a 4-point scale; 2) 6-items relate to household activity are rated on dichotomous (yes or no) scale; 3) work-related activity is rated by whether the activity is a paid or volunteer work; 4) The duration (in hours) spent on such activities will be reported by the participants. 5) The total PASE-C score will be calculated by adding the score of each item determined on the basis of the time spent on each activity or the presence or absence of activity over the past 7 days.6) Amount of time spent in each activity multiplied by PASE-C item weights & adding all scores together for the final PASE-C score. A high score indicates a high level of physical activity.

  8. Participants' depressive mood will be assessed by the 15-item Chinese version Geriatric Depression Scale (C-GDS) [ Time Frame: To detect the change from baseline C-GDS total score at mid-term programme (wk 8 after commences of the programme),and then 1 week, 6 month and 12 months months after the completion of the programme ]
    The C-GDS consists of 15 yes/no questions. Each negative answer will be given 1 point, with possible scores ranging from 0-15. The higher score indicates more depressive mood. • Respondents with a score more than 8 are identified as having symptoms of depression.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • community-dwelling older people aged > 70 years;
  • able to communicate in Cantonese to ensure that they understand our instructions;
  • able to walk with or without an assistive device and able to complete the Time Up and Go (TUG) test with no specific cutoff point to ensure that their mobility and balance is good enough to join the exercise training; and
  • in a frail state with exhaustion as determined using the Fried Frailty Index (FFI), including: i) an unintentional loss of 10% of body weight in the past year; ii) exhaustion: by answering 'Yes' to either 'I felt that everything I did was an effort', or 'I could not get going in the last week'; iii) a slow walk time: with an average walking speed in the lowest quintile stratified by median body height; iv) reduced grip strength: with maximal grip strength in the lowest quintile stratified by body mass index quartile; and v) the Physical Activity Scale for the Elderly-Chinese (PASE-C) score in the lowest quintile (i.e., < 30 for men and < 27.7 for women). The presence of > 3 items indicates frailty, and one criterion indicates that they suffer from exhaustion.

Exclusion Criteria: are older people who:

  • are suffering from any disease in which fatigue is a dominant symptom (such as neurodegenerative diseases, cancer, and end-stage renal failure cachexia cases;
  • have been hospitalized for > 5 days in the preceding 3 months, which may lead to muscle wasting due to recent bed rest or reduced activity levels during hospitalization;
  • underwent major surgery (such as total joint replacement, major abdominal surgeries) during the last 6 months;
  • are confined to bed or restricted by the permanent use of a wheelchair;
  • report that they regularly perform moderately intense exercise (such as hiking, Tai Chi) for > 3 hours per week;
  • are terminally ill;
  • have been diagnosed with major depression entailing frequent adjustments of their antidepressants to control unstable depressive moods. The criteria were chosen to avoid recruiting people with depression-induced fatigue. However, a consistent feeling of fatigue may manifest as a depressed mood. Thus, the participants' mood will be assessed using the Chinese-Geriatric Depression Scale (C-GDS).

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): NCT03394495


Contacts
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Contact: Yat-wa Justina Liu 27664097 justina.liu@polyu.edu.hk

Locations
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Hong Kong
Justina Liu Recruiting
Hong Kong, Hong Kong
Contact: Justina YW LIU    85227664097    justina.liu@polyu.edu.hk   
Contact: Evelyn Nip    85227668295    evelyn.nip@polyu.edu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Yat-wa Justina Liu The Hong Kong Polytechnic University
  Study Documents (Full-Text)

Documents provided by Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University:
Informed Consent Form  [PDF] December 15, 2017
Study Protocol  [PDF] December 15, 2017
Statistical Analysis Plan  [PDF] December 15, 2017

Publications:
Clark LV, White PD. The role of deconditioning and therapeutic exercise in chronic fatigue syndrome (CFS). Journal of Mental Health. 2005; 14(3): 237-52.
Martin KA, Sinden AR. Who will stay and who will go? A review of older adults' adherence to randomized controlled trials of exercise. J Aging Phys Act. 2001; 9(2): 91-114.
Larun L, Brurberg KG, Odgaard-Jensen J, Price JR. Exercise therapy for chronic fatigue syndrome. status and date: New search for studies and content updated (no change to conclusions), published in. 2015; (2).
Nash KC. The effects of exercise on strength and physical performance in frail older people: a systematic review. Rev Clin Gerontol. 2012; 22(4): 274.
Network NCC. NCCN clinical practice guideline in oncology: cancer-related fatigue. Available from: www nccn org. 2013.
Schwarzer R. Modeling health behavior change: How to predict and modify the adoption and maintenance of health behaviors. Appl Psychol-Int Rev. 2008; 57(1): 1 - 29.
Lippke S, Ziegelmann JP, Schwarzer R. Behavioral intentions and action plans promote physical exercise: a longitudinal study with orthopedic rehabilitation patients. J Sport Exerc Psychol. 2004; 26(3): 470.
Rikli R, Jones C. Development and validation of a functional fitness test for community-residing older adults. J Aging Phys Act. 1999; 7(2): 129 - 61.
Ku P-W, Sun W-J, Chang C-Y, Chen L-J. Reliability and validity of the Chinese version of the Physical Activity Scale for the Elderly. Sports & Exercise Research. 2013; 15(3): 309-19.
Stevens JP. Applied multivariate statistics for the social sciences: Routledge; 2012.
Krippendorff K. Content analysis: An introduction to its methodology: Sage; 2004.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Justina Liu Yat Wa, Associate Professor, The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT03394495    
Other Study ID Numbers: 15600717
First Posted: January 9, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: For confidentiality, the data will be kept anonymous and the names of all participants will be replaced by reference codes. The data collected will be kept in a locked place and electronic versions will be encrypted, and only be accessible by the researchers. All data will be destroyed within 3 years after the completion of this research.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Justina Liu Yat Wa, The Hong Kong Polytechnic University:
Fatigue
Frailty
Cluster-RCT
Exercise
Behavioral change
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms